Clincosm LogoSign in Get a demo

CTR3: Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

Sponsor
Jaeb Center for Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT02137512
Collaborator
(none)
30
Enrollment
6
Locations
2
Arms
15
Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if an automated insulin management system ("study system") can safely be used at home to manage blood sugar. The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed and allows the study participant user to control the whole system, and (3) an insulin pump that delivers the insulin. The CGM will be from Dexcom. The pump will be from Roche. The CGM and pump are similar to the devices that are currently available for people to purchase and use. However, the smartphone device, the CGM sensor type used with it, and the overall study system can only be used for research at this time.

The study will be completed by about 24 individuals at 6 centers in the United States and Europe. This study has several phases and will take about 11-14 weeks to complete depending on whether the study participant is a CGM user or not.

At selected sites (based on subject eligibility and availability), approximately 10-20 subjects who exhibit safe and competent use of the system at home will be given the option to continue home use of the system in Day-and-Night Closed-Loop mode for up to 5 months.

Condition or Disease Intervention/Treatment Phase
  • Device: Closed-Loop Control System
  • Device: Sensor-Augmented Pump (SAP)
 N/A

Detailed Description

The study phases are as follows:

  • Screening visit to see if you are eligible for the study and to determine how long you will need to use the study CGM (visit 1)

  • Up to 3 weeks using the study CGM (depends on your current CGM use), followed by an office visit (visit 2)

  • 2 weeks using the study insulin pump and study CGM together

  • Full day visit in clinic or hotel for training using the system (visit 3)

  • 1 week using the system without automated insulin delivery or suspension

  • 2-day hotel or clinic visit for closed-loop training (visit 4),

  • 16-19 days using the system in the evening and overnight only followed by an office visit (visit 5)

  • 16-19 days using the system for the full 24 hours

  • Final study clinic visit (visit 6)

  • Option 5 month extension phase of day-and-night closed-loop home use

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Closed-Loop Control System

Use of an investigational control-to-range automated insulin management (artificial pancreas) system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.

Device: Closed-Loop Control System
This investigational device system included the following components: DiAs - a smart-phone medical platform; Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
Other Names:
  • Diabetes Assistant (DiAs)

    		•
    Active Comparator: Sensor-Augmented Pump (SAP)

    Use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump

    Device: Sensor-Augmented Pump (SAP)
    This commercial device system included the following components: Dexcom G4 Platinum CGM system; Roche Accu-Chek insulin pump

    Outcome Measures

    Primary Outcome Measures

    1. Time Spent <70 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)

    Secondary Outcome Measures

    1. Time Spent <70 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase

    2. Time Spent <70 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)

    3. Time in Range 70-180 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase

    4. Time in Range 70-180 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)

    5. Time in Range 70-180 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)

    6. Mean Sensor Glucose - Main Phase, Day and Night [2 weeks]

      Mean CGM sensor glucose during study Main Phase

    7. Mean Sensor Glucose - Main Phase, Night Only [2 weeks]

      Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)

    8. Mean Sensor Glucose - Main Phase, Day Only [2 weeks]

      Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)

    9. Glucose Coefficient of Variation - Main Phase, Day and Night [2 weeks]

      CGM Glucose Coefficient of Variation (CV) during study Main Phase

    10. Glucose Coefficient of Variation - Main Phase, Night Only [2 weeks]

      CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)

    11. Glucose Coefficient of Variation - Main Phase, Day Only [2 weeks]

      CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)

    12. Glucose Standard Deviation - Main Phase, Day and Night [2 weeks]

      CGM Glucose Standard Deviation (SD) during study Main Phase

    13. Glucose Standard Deviation - Main Phase, Night Only [2 weeks]

      CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)

    14. Glucose Standard Deviation - Main Phase, Day Only [2 weeks]

      CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)

    15. Time Spent >180 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase

    16. Time Spent >180 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)

    17. Time Spent >180 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)

    18. Time Spent <50 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase

    19. Time Spent <50 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)

    20. Time Spent <50 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)

    21. Time Spent <60 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase

    22. Time Spent <60 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)

    23. Time Spent <60 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)

    24. LBGI - Main Phase, Day and Night [2 weeks]

      Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

    25. LBGI - Main Phase, Night Only [2 weeks]

      Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

    26. LBGI - Main Phase, Day Only [2 weeks]

      Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.

    27. AOC 70 mg/dL - Main Phase, Day and Night [2 weeks]

      Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

    28. AOC 70 mg/dL - Main Phase, Night Only [2 weeks]

      Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

    29. AOC 70 mg/dL - Main Phase, Day Only [2 weeks]

      Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.

    30. HBGI - Main Phase, Day and Night [2 weeks]

      High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

    31. HBGI - Main Phase, Night Only [2 weeks]

      High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

    32. HBGI - Main Phase, Day Only [2 weeks]

      High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.

    33. ADRR - Main Phase, Day and Night [2 weeks]

      Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.

    34. AUC 180 mg/dL - Main Phase, Day and Night [2 weeks]

      Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

    35. AUC 180 mg/dL - Main Phase, Night Only [2 weeks]

      Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

    36. AUC 180 mg/dL - Main Phase, Day Only [2 weeks]

      Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).

    37. Time Spent >250 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase

    38. Time Spent >250 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)

    39. Time Spent >250 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)

    40. Time Spent >300 mg/dL - Main Phase, Day and Night [2 weeks]

      Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase

    41. Time Spent >300 mg/dL - Main Phase, Night Only [2 weeks]

      Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)

    42. Time Spent >300 mg/dL - Main Phase, Day Only [2 weeks]

      Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00)

    Other Outcome Measures

    1. Mean Sensor Glucose - Extension Phase [3 months]

      Mean CGM sensor glucose during Extension Phase

    2. Change in HbA1c - Extension Phase [5 months]

      Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase

    3. Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase

    4. Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase

    5. Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase

    6. Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL)

    7. Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase

    8. Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase

    9. Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase [3 months]

      Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase

    10. Episodes of Severe Hypoglycemia Events - Extension Phase [5 months]

      Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

    11. Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase [5 months]

      Episodes of DKA events that occurred during the 5-month extension phase

    12. Reported Serious Adverse Events - Extension Phase [5 months]

      Reported serious adverse events during the 5-month extension phase

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year and an insulin pump for at least 6 months.

    2. Age >=18 to <70 years.

    3. HbA1c <10.0%; if HbA1c <6.0% then total daily insulin must be >=0.5 U/kg

    4. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

    5. Demonstration of proper mental status and cognition for the study.

    6. Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes

    7. Hypoglycemia awareness as demonstrated by a Clarke Hypoglycemia Awareness score of 2 or lower

    8. Access to internet and cell phone service at home, and a computer for downloading device data.

    9. Living with significant other or family member committed to participating in all training activities, knowledgeable at all times of the participant's location, and being present and available to provide assistance when system is being used at night.

    10. Commitment to maintaining uninterrupted availability via cell phone and avoiding any overnight travel for the duration of each two-week period using the closed-loop system.

    11. An understanding of and willingness to follow the protocol and sign the informed consent.

    Exclusion Criteria:

    1. Admission for diabetic ketoacidosis in the 12 months prior to enrollment.

    2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.

    3. History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist.

    4. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.

    5. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)

    6. Cystic fibrosis.

    7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

    • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)

    • Presence of a known adrenal disorder

    • Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function

    • Abnormal renal function test results (calculated GFR <60); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty

    • Active gastroparesis

    • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study

    • Uncontrolled thyroid disease (TSH undetectable or >10); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise

    • Abuse of alcohol or recreational drugs

    • Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)

    1. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol 8.
    Current use of the following drugs and supplements:

    • Acetaminophen

    • Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose

    • Beta blockers

    • Oral or injectable glucocorticoids

    • Any other medication that the investigator believes is a contraindication to the subject's participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sansum Diabetes Research Institute Santa Barbara California United States 93105
    2 Stanford University Stanford California United States 94305
    3 University of Virginia Charlottesville Virginia United States 22908
    4 Montpellier University Hospital Montpellier France 34295
    5 National Center for Childhood Diabetes- Schneider Children's Medical Center Petah Tikva Israel 49202
    6 University of Padova Padova Italy 93106

    Sponsors and Collaborators

    • Jaeb Center for Health Research

    Investigators

    • Principal Investigator: Roy Beck, MD, PhD, Jaeb Center for Health Research
    • Study Chair: Boris Kovatchev, PhD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT02137512
    Other Study ID Numbers:
    • Pilot 3 Outpatient CTR
    First Posted:
    May 13, 2014
    Last Update Posted:
    Oct 29, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Jaeb Center for Health Research
    Artificial Pancreas
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Closed-Loop Control System
    Arm/Group Description A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
    Period Title: 2-Week Baseline Sensor-Augmented Pump
    STARTED 30
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: 2-Week Baseline Sensor-Augmented Pump
    STARTED 30
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: 2-Week Baseline Sensor-Augmented Pump
    STARTED 30
    COMPLETED 30
    NOT COMPLETED 0
    Period Title: 2-Week Baseline Sensor-Augmented Pump
    STARTED 14
    COMPLETED 14
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Closed-Loop Control System
    Arm/Group Description A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
    Overall Participants 30
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    44
    Sex: Female, Male (Count of Participants)
    Female
    13
    43.3%
    Male
    17
    56.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    1
    3.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    24
    80%
    More than one race
    0
    0%
    Unknown or Not Reported
    5
    16.7%
    Region of Enrollment (participants) [Number]
    United States
    15
    50%
    Italy
    5
    16.7%
    Israel
    5
    16.7%
    France
    5
    16.7%
    Diabetes duration (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    19
    Body-mass index (BMI) (kg/m^2) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [kg/m^2]
    25
    Hemoglobin A1c (HbA1c) (percent) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [percent]
    7.3
    Daily total insulin dose (U/kg/day) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [U/kg/day]
    0.57
    Daily basal insulin (U/kg/day) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [U/kg/day]
    0.27

    Outcome Measures

    1. Primary Outcome
    Title Time Spent <70 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    3.0
    1.1
    0.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments No adjustments were made for multiple comparisons.
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    2. Secondary Outcome
    Title Time Spent <70 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    4.1
    2.6
    1.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    3. Secondary Outcome
    Title Time Spent <70 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    4.6
    3.2
    2.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    4. Secondary Outcome
    Title Time in Range 70-180 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    65
    73
    73
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.91
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    5. Secondary Outcome
    Title Time in Range 70-180 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    61
    75
    72
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    6. Secondary Outcome
    Title Time in Range 70-180 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    65
    70
    72
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.49
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    7. Secondary Outcome
    Title Mean Sensor Glucose - Main Phase, Day and Night
    Description Mean CGM sensor glucose during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Mean (Standard Deviation) [mg/dL]
    157
    (18)
    149
    (12)
    153
    (12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    8. Secondary Outcome
    Title Mean Sensor Glucose - Main Phase, Night Only
    Description Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Mean (Standard Deviation) [mg/dL]
    163
    (23)
    150
    (12)
    154
    (13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    9. Secondary Outcome
    Title Mean Sensor Glucose - Main Phase, Day Only
    Description Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Mean (Standard Deviation) [mg/dL]
    154
    (19)
    148
    (15)
    152
    (14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.54
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    10. Secondary Outcome
    Title Glucose Coefficient of Variation - Main Phase, Day and Night
    Description CGM Glucose Coefficient of Variation (CV) during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage]
    38
    35
    34
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    11. Secondary Outcome
    Title Glucose Coefficient of Variation - Main Phase, Night Only
    Description CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage]
    36
    30
    32
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.52
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    12. Secondary Outcome
    Title Glucose Coefficient of Variation - Main Phase, Day Only
    Description CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage]
    38
    37
    35
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.13
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    13. Secondary Outcome
    Title Glucose Standard Deviation - Main Phase, Day and Night
    Description CGM Glucose Standard Deviation (SD) during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    61
    52
    51
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    14. Secondary Outcome
    Title Glucose Standard Deviation - Main Phase, Night Only
    Description CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    61
    47
    48
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    15. Secondary Outcome
    Title Glucose Standard Deviation - Main Phase, Day Only
    Description CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    58
    55
    53
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    16. Secondary Outcome
    Title Time Spent >180 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    32
    24
    25
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.26
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    17. Secondary Outcome
    Title Time Spent >180 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    37
    24
    27
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.11
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    18. Secondary Outcome
    Title Time Spent >180 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    31
    23
    25
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.61
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    19. Secondary Outcome
    Title Time Spent <50 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    0.8
    0.2
    0.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.29
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    20. Secondary Outcome
    Title Time Spent <50 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    0.3
    0.0
    0.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value >0.99
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    21. Secondary Outcome
    Title Time Spent <50 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    0.9
    0.2
    0.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.09
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    22. Secondary Outcome
    Title Time Spent <60 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    2.2
    1.1
    0.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    23. Secondary Outcome
    Title Time Spent <60 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    1.4
    0.2
    0.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.26
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    24. Secondary Outcome
    Title Time Spent <60 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    2.4
    1.4
    0.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    25. Secondary Outcome
    Title LBGI - Main Phase, Day and Night
    Description Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    1.1
    0.8
    0.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    26. Secondary Outcome
    Title LBGI - Main Phase, Night Only
    Description Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    0.7
    0.4
    0.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 1 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.53
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    27. Secondary Outcome
    Title LBGI - Main Phase, Day Only
    Description Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    1.2
    0.9
    0.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    28. Secondary Outcome
    Title AOC 70 mg/dL - Main Phase, Day and Night
    Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    0.5
    0.3
    0.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    29. Secondary Outcome
    Title AOC 70 mg/dL - Main Phase, Night Only
    Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    0.3
    0.1
    0.0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.22
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    30. Secondary Outcome
    Title AOC 70 mg/dL - Main Phase, Day Only
    Description Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    0.6
    0.3
    0.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    31. Secondary Outcome
    Title HBGI - Main Phase, Day and Night
    Description High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    6.8
    5.0
    5.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.26
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    32. Secondary Outcome
    Title HBGI - Main Phase, Night Only
    Description High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    7.5
    5.1
    5.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    33. Secondary Outcome
    Title HBGI - Main Phase, Day Only
    Description High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [index scores]
    6.4
    5.1
    5.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.52
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    34. Secondary Outcome
    Title ADRR - Main Phase, Day and Night
    Description Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [range scores]
    27
    24
    24
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.71
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    35. Secondary Outcome
    Title AUC 180 mg/dL - Main Phase, Day and Night
    Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    15.0
    9.2
    11.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    36. Secondary Outcome
    Title AUC 180 mg/dL - Main Phase, Night Only
    Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    17.7
    8.4
    9.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    37. Secondary Outcome
    Title AUC 180 mg/dL - Main Phase, Day Only
    Description Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [mg/dL]
    13.6
    10.0
    9.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.86
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    38. Secondary Outcome
    Title Time Spent >250 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    7
    4
    5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.74
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    39. Secondary Outcome
    Title Time Spent >250 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    8
    3
    4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.09
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    40. Secondary Outcome
    Title Time Spent >250 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    6
    5
    5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.68
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    41. Secondary Outcome
    Title Time Spent >300 mg/dL - Main Phase, Day and Night
    Description Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    2
    1
    1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.62
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    42. Secondary Outcome
    Title Time Spent >300 mg/dL - Main Phase, Night Only
    Description Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    2
    0
    0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    43. Secondary Outcome
    Title Time Spent >300 mg/dL - Main Phase, Day Only
    Description Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 2-Week Overnight-Only Closed-Loop 2-Week 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period Overnight-only home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 2-Week period
    Measure Participants 29 29 29
    Median (Inter-Quartile Range) [percentage of CGM values]
    2
    1
    1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.67
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.09
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2-Week Overnight-Only Closed-Loop, 2-Week 24/7 Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.22
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    44. Other Pre-specified Outcome
    Title Mean Sensor Glucose - Extension Phase
    Description Mean CGM sensor glucose during Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Mean (Standard Deviation) [mmol/L]
    8.6
    (1.1)
    8.3
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.25
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    45. Other Pre-specified Outcome
    Title Change in HbA1c - Extension Phase
    Description Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase
    Time Frame 5 months

    Outcome Measure Data

    Analysis Population Description
    One participant was excluded due to missing baseline CGM data
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Mean (Standard Deviation) [percentage]
    7.2
    (0.6)
    7.0
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.23
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    46. Other Pre-specified Outcome
    Title Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [mmol/L]
    4.1
    1.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    47. Other Pre-specified Outcome
    Title Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [mmol/L]
    2.2
    0.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    48. Other Pre-specified Outcome
    Title Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [mmol/L]
    1.0
    0.1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    49. Other Pre-specified Outcome
    Title Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL)
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [percentage of CGM values in range]
    66
    77
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    50. Other Pre-specified Outcome
    Title Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [percentage of CGM values >10.0 mmol/L]
    31
    22
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    51. Other Pre-specified Outcome
    Title Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [percentage of CGM values in range]
    6
    3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    52. Other Pre-specified Outcome
    Title Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase
    Description Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    One subject had missing CGM data at baseline and was not included in this analysis
    Arm/Group Title 2-Week Baseline Sensor-Augmented Pump 5-Month 24/7 Closed-Loop
    Arm/Group Description Home use of a study-assigned commercial continuous glucose monitoring (CGM) system and commercial insulin pump for a 2-Week period 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 13 13
    Median (Inter-Quartile Range) [percentage of CGM values in range]
    2
    0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2-Week Baseline Sensor-Augmented Pump, 2-Week Overnight-Only Closed-Loop
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments No adjustments were made for multiple comparisons.
    Method t-test, 2 sided
    Comments
    53. Other Pre-specified Outcome
    Title Episodes of Severe Hypoglycemia Events - Extension Phase
    Description Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
    Time Frame 5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 5-Month 24/7 Closed-Loop
    Arm/Group Description 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 14
    Number [events]
    0
    54. Other Pre-specified Outcome
    Title Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase
    Description Episodes of DKA events that occurred during the 5-month extension phase
    Time Frame 5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 5-Month 24/7 Closed-Loop
    Arm/Group Description 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 14
    Number [events]
    0
    55. Other Pre-specified Outcome
    Title Reported Serious Adverse Events - Extension Phase
    Description Reported serious adverse events during the 5-month extension phase
    Time Frame 5 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 5-Month 24/7 Closed-Loop
    Arm/Group Description 24/7 (night and day) home use of a control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes for a 5-Month period
    Measure Participants 14
    Number [events]
    0

    Adverse Events

    Time Frame 12-weeks during the main portion of the study and 5 months in the optional extension phase of the study.
    Adverse Event Reporting Description
    Arm/Group Title Closed-Loop Control System
    Arm/Group Description A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment. Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class
    All Cause Mortality
    Closed-Loop Control System
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Closed-Loop Control System
    Affected / at Risk (%) # Events
    Total 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Closed-Loop Control System
    Affected / at Risk (%) # Events
    Total 9/30 (30%)
    Endocrine disorders
    Ketosis 1/30 (3.3%) 2
    Hyperglycemia 1/30 (3.3%) 1
    Gastrointestinal disorders
    Nausea 1/30 (3.3%) 1
    General disorders
    Cold 2/30 (6.7%) 2
    Infections and infestations
    Tooth Infection 1/30 (3.3%) 1
    Injury, poisoning and procedural complications
    Skin injury 1/30 (3.3%) 1
    Musculoskeletal and connective tissue disorders
    Shoulder Pain 1/30 (3.3%) 1
    Renal and urinary disorders
    Urinary tract infection 1/30 (3.3%) 2
    Reproductive system and breast disorders
    Endometriosis 1/30 (3.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Sinus Infection 1/30 (3.3%) 1
    Upper Respiratory Infection 2/30 (6.7%) 2
    Sore Throat 1/30 (3.3%) 1
    Pneumonia 1/30 (3.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title John Lum, Artificial Pancreas Project Director
    Organization Jaeb Center for Health Research
    Phone 8139758690
    Email jlum@jaeb.org
    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT02137512
    Other Study ID Numbers:
    • Pilot 3 Outpatient CTR
    First Posted:
    May 13, 2014
    Last Update Posted:
    Oct 29, 2018
    Last Verified:
    Aug 1, 2018