A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02092220
• Collaborator: Boston University (Other)
• Enrollment: 48
• Locations: 4
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site: 12
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will test the hypothesis that a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults with type 1 diabetes.

Please note that all participants must work or attend school at one of the following campuses: Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1	Device: Bionic Pancreas; Device: Insulin pump with or without CGM	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic Pancreas
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bionic Pancreas Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Device: Bionic Pancreas
Active Comparator: Usual Care Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.	Device: Insulin pump with or without CGM

Outcome Measures

Primary Outcome Measures

1. Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11 [Days 2 to 11 of each period]

   Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.

2. Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11 [Days 2 to 11 of each period]

   Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.

Secondary Outcome Measures

1. Mean CGMG Values [Day 1 and Days 1 to 11 in each period]

   Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.

2. Percentage of Time With CGMG Concentration by Ranges During Day 1 [Day 1 of each period]

   Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

3. Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11 [Days 1 to 11 of each period]

   Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

4. Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11 [Days 2 to 11 of each period]

   Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)

5. Percentage of Participants With Mean CGMG < 154 mg/dl [Day 1, Days 2 to11, Days 1 to11 of each period]

   Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.

6. Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) [Days 1-11]

   A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.

7. Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care [Days 1-11 of each period]

   The percentage of days that participants reported the CGM device was being worn and working properly is reported.

8. Glycated Albumin on Day 12 [Day 12 of each period]

9. 1,5-anhydroglucitol on Day 12 [Day 12 of each period]

10. Anti-Insulin and Anti-Glucagon Antibodies on Day 12 [Day 12 of each period]

11. Number of Participants With Severe Hypoglycemic Events [11 days of each period]

    A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.

12. Number of Episodes of Symptomatic Hypoglycemia [Day 1, Days 1 to 11 and Days 2 to 11 of each period]

    The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.

13. Number of Reported Carbohydrate Interventions for Hypoglycemia [Day 1, Days 1 to 11 and Days 2 to 11 of each period]

    The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.

14. Total Grams of Carbohydrate Taken for Hypoglycemia [Day 1, Days 1 to 11 and Days 2 to 11 of each period]

    The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged. The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported.

15. Insulin Total Daily Dose [Day 1, Days 1 to 11, Days 2 to 11 of each period]

    Insulin total daily dose is reported in units per kilogram per day (U/kg/day).

16. Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm [Day 1, Days 2 to 11, Days 1 to 11 of each period]

    Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).

17. Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm [Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period]

18. Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly [11 days]

    Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.

19. Mean Nausea Index Score Using a Visual Analog Scale (VAS) [Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period]

    Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.

20. Change From Baseline in Body Weight [Baseline and Day 12 of each period]

    The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.

21. Change From Baseline in Hemoglobin [Baseline and Day 12 of each period]

    The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.

22. Number of Participants With Skin Rash [11 days of each period]

Other Outcome Measures

1. Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM [11 days]

2. Number of Unscheduled Infusion Set Replacements [11 days]

3. Mean Daily Basal Insulin Dose [Day 1, Days 2 to 11, each individual day 2 to 11 of each period]

   Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).

4. Mean Daily Bolus Insulin Dose [Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period]

   Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).

5. CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads [11 days]

   This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥18 years and have had clinical type 1 diabetes for at least one year

• Diabetes managed using an insulin pump for ≥ 6 months

• Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgement of the site principal investigator).

• Employee or student working or studying during most of the week at one of the participating campuses (Massachusetts General Hospital in Boston, MA; University of Massachusetts Medical Center in Worcester, MA; University of North Carolina in Chapel Hill, NC; Stanford University in Palo Alto, CA)

• Lives within a 30 minute drive-time radius of the central monitoring location for one of the study sites

• Willing to remain within a 60 minute drive-time radius of the central monitoring location for one of the study sites during each of the 11-day study arms

• Have someone over 18 years of age who lives with them, has access to where they sleep, is willing to be in the house when the subject is sleeping, and is willing to receive calls from the study staff and check the welfare of the study subject if telemetry shows a technical problem or severe biochemical hypoglycemia without subject response and the subject does not answer their telephone (up to two individuals can share this role, but they must be willing to carefully coordinate with each other and the subject so that one of them is clearly designated as having this responsibility at any given time)

• Willing to wear two infusion sets and continuous glucose monitor (CGM) sensor and change sets frequently (at least one new glucagon infusion set daily)

Exclusion Criteria:

• Unable to provide informed consent (e.g. impaired cognition or judgment)

• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory, unable to speak and read English)

• Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the subject

• Pregnancy [positive urine human chorionic gonadotropin (HCG)] breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception

• Need to go outside of the designated geographic boundaries during either arm of the study

• Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)

• Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial

• Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of beta blockers will be allowed as long as the dose is stable and the subject does not meet the criteria for hypoglycemia unawareness while taking that stable dose, but use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)

• History of liver disease that is expected to interfere with the anti-hypoglycemia action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.

• Renal failure on dialysis

• Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes

• Any known history of coronary artery disease including, but not limited to, history of myocardial infarction, stress test showing ischemia, history of angina, or history of intervention such as coronary artery bypass grafting, percutaneous coronary intervention, or enzymatic lysis of a presumed coronary occlusion)

• Abnormal electrocardiogram (EKG) consistent with coronary artery disease or increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, prior myocardial infarction, proximal left anterior descending coronary artery (LAD) critical stenosis (Wellen's sign), prolonged QT interval (> 440 ms). Non-specific ST segment and T wave changes are not grounds for exclusion in the absence of symptoms or history of heart disease. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.

• Congestive heart failure (CHF) [established history of CHF, lower extremity edema, paroxysmal nocturnal dyspnea, or orthopnea]

• History of transient ischaemic attack (TIA) or stroke

• Seizure disorder, history of any non-hypoglycemic seizure within the last two years, or ongoing treatment with anticonvulsants

• History of hypoglycemic seizures or coma in the last year

• History of pheochromocytoma: fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor:

• episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension

• paroxysms of tachycardia, pallor, or headache

• personal or family history of multiple endocrine neoplasia type 2A (MEN 2A), multiple endocrine neoplasia type 2B (MEN 2B), neurofibromatosis, or von Hippel-Lindau disease

• History of adrenal disease or tumor

• Hypertension with systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 despite treatment

• Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.

• Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radio-frequency (RF) interference

• Unable to completely avoid acetaminophen for duration of study

• History of adverse reaction to glucagon (including allergy) besides nausea and vomiting

• Established history of allergy or severe reaction to adhesive or tape that must be used in the study

• History of eating disorder such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight

• History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment

• Use oral [e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors] anti-diabetic medications

• Lives in or frequents areas with poor Verizon wireless network coverage (which would prevent remote monitoring)

• Any factors that, in the opinion of the site principal investigator or overall principal investigator, would interfere with the safe completion of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Massachusetts General Hospital (MGH) Diabetes Research Center	Boston	Massachusetts	United States	02114
3	UMass Medical Center	Worcester	Massachusetts	United States	01655
4	University of North Carolina Chapel Hill	Chapel Hill	North Carolina	United States	27514

Sponsors and Collaborators

• Massachusetts General Hospital
• Boston University

Investigators

• Principal Investigator: Steven J Russell, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02092220
• Other Study ID Numbers: Multicenter Study
• First Posted: Mar 20, 2014
• Last Update Posted: Nov 22, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital: Bionic Pancreas; Insulin; Glucagon; Continuous Glucose Monitor
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1; Pancrelipase

Study Results

Participant Flow

Pre-assignment Detail	48 participants were enrolled in the trial, but only 43 participants actually participated. 2 participants were not eligible and 3 participants were not randomized because target enrollment was already met.

Arm/Group Title	Bionic Pancreas Then Usual Care	Usual Care Then Bionic Pancreas
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 1 followed by Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days in Period 1 followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days in Period 2. There was a 3 to 10-day washout period between periods.
Period Title: Period 1
STARTED	21	22
COMPLETED	21	20
NOT COMPLETED	0	2
Period Title: Period 1
STARTED	21	20
COMPLETED	20	19
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	All Randomized Participants
Arm/Group Description	All randomized participants who completed both periods of the study.
Overall Participants	39
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	39 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (11.0)
Sex: Female, Male (Count of Participants)
Female	21 53.8%
Male	18 46.2%

Outcome Measures

1. Primary Outcome

Title	Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11
Description	Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.
Time Frame	Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [milligrams/deciliter (mg/dL)]	141.2 (9.9)	161.5 (28.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bionic Pancreas, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Repeated measures model.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.28
	Confidence Interval	(2-Sided) 95%; -28.00 to -12.56
	Parameter Dispersion	Type: Standard Deviation; Value: 24.59
	Estimation Comments	Bionic Pancreas Arm - Usual Care Arm

2. Primary Outcome

Title	Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11
Description	Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.
Time Frame	Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [percentage of time]	0.6 (0.6)	1.9 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bionic Pancreas, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Repeated measures model.
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.8 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean CGMG Values
Description	Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.
Time Frame	Day 1 and Days 1 to 11 in each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	145.3 (17.6)	161.9 (45.2)
Days 1 to 11	141.5 (10.0)	161.7 (29.3)

4. Secondary Outcome

Title	Percentage of Time With CGMG Concentration by Ranges During Day 1
Description	Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Time Frame	Day 1 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
< 50 mg/dl (2.8 mmol/L)	0.1 (0.3)	0.9 (1.5)
< 60 mg/dL (3.3 mmol/L)	0.5 (0.9)	2.3 (3.4)
< 70 mg/dl (3.9 mmol/L)	1.5 (2.3)	5.0 (6.5)
70 to 120 mg/dL (3.9 to 6.7 mmol/L)	39.4 (13.6)	28.5 (18.6)
70-180 mg/dl (3.9 to 10.0 mmol/L)	76.8 (11.5)	62.1 (22.2)
> 180 mg/dL (10.0 mmol/L)	21.7 (11.2)	32.9 (24.0)
> 250 mg/dL (13.9 mmol/L)	6.0 (7.4)	12.3 (17.7)

5. Secondary Outcome

Title	Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11
Description	Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Time Frame	Days 1 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
< 50 mg/dl (2.8 mmol/L)	0.1 (0.1)	0.6 (0.6)
< 60 mg/dL (3.3 mmol/L)	0.6 (0.5)	1.9 (1.8)
< 70 mg/dl (3.9 mmol/L)	1.8 (1.4)	4.6 (3.9)
70 to 120 mg/dL (3.9 to 6.7 mmol/L)	40.6 (8.0)	27.5 (11.3)
70-180 mg/dl (3.9 to 10.0 mmol/L)	78.3 (6.0)	61.9 (14.5)
> 180 mg/dL (10.0 mmol/L)	19.9 (6.0)	33.5 (16.5)
> 250 mg/dL (13.9 mmol/L)	4.4 (2.7)	11.0 (10.3)

6. Secondary Outcome

Title	Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11
Description	Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)
Time Frame	Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
< 50 mg/dl (2.8 mmol/L)	0.1 (0.2)	0.6 (0.6)
< 70 mg/dl (3.9 mmol/L)	1.8 (1.4)	4.5 (3.8)
70 to 120 mg/dL (3.9 to 6.7 mmol/L)	40.7 (7.8)	27.4 (11.4)
70-180 mg/dl (3.9 to 10.0 mmol/L)	78.4 (6.0)	61.9 (14.4)
> 180 mg/dL (10.0 mmol/L)	19.8 (6.1)	33.6 (16.4)
> 250 mg/dL (13.9 mmol/L)	4.2 (2.7)	10.9 (10.0)

7. Secondary Outcome

Title	Percentage of Participants With Mean CGMG < 154 mg/dl
Description	Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.
Time Frame	Day 1, Days 2 to11, Days 1 to11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	79 202.6%	59 NaN
Days 1 to 11	92 235.9%	41 NaN
Days 2 to 11	92 235.9%	41 NaN

8. Secondary Outcome

Title	Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Description	A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.
Time Frame	Days 1-11

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
<50 mg/dl	0.58 (0.87)	1.0 (1.06)
<60 mg/dl	1.33 (1.31)	2.88 (2.67)
<70 mg/dl	2.68 (2.4)	5.28 (4.14)

9. Secondary Outcome

Title	Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care
Description	The percentage of days that participants reported the CGM device was being worn and working properly is reported.
Time Frame	Days 1-11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.

Arm/Group Title	Usual Care
Arm/Group Description	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39
Number [percentage of days]	49

10. Secondary Outcome

Title	Glycated Albumin on Day 12
Time Frame	Day 12 of each period

Outcome Measure Data

Analysis Population Description

No data was collected for Glycated Albumin.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	0	0

11. Secondary Outcome

Title	1,5-anhydroglucitol on Day 12
Time Frame	Day 12 of each period

Outcome Measure Data

Analysis Population Description

No data was collected for 1,5-anhydroglucitol.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	0	0

12. Secondary Outcome

Title	Anti-Insulin and Anti-Glucagon Antibodies on Day 12
Time Frame	Day 12 of each period

Outcome Measure Data

Analysis Population Description

No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	0	0

13. Secondary Outcome

Title	Number of Participants With Severe Hypoglycemic Events
Description	A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Time Frame	11 days of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Count of Participants [Participants]	0 0%	1 NaN

14. Secondary Outcome

Title	Number of Episodes of Symptomatic Hypoglycemia
Description	The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.
Time Frame	Day 1, Days 1 to 11 and Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.74 (1.04)	1.13 (1.12)
Days 1 to 11	0.59 (0.56)	0.90 (0.64)
Days 2 to 11	0.57 (0.54)	0.88 (0.64)

15. Secondary Outcome

Title	Number of Reported Carbohydrate Interventions for Hypoglycemia
Description	The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.
Time Frame	Day 1, Days 1 to 11 and Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.36 (0.63)	1.29 (1.25)
Days 1 to 11	0.39 (0.34)	0.96 (0.72)
Days 2 to 11	0.40 (0.34)	0.93 (0.72)

16. Secondary Outcome

Title	Total Grams of Carbohydrate Taken for Hypoglycemia
Description	The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged. The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported.
Time Frame	Day 1, Days 1 to 11 and Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	6.18 (11.61)	25.61 (26.12)
Days 1 to 11	22.04 (13.62)	34.8 (16.21)
Days 2 to 11	22.27 (13.79)	34.8 (16.84)

17. Secondary Outcome

Title	Insulin Total Daily Dose
Description	Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time Frame	Day 1, Days 1 to 11, Days 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.64 (0.20)	0.64 (0.21)
Days 1 to 11	0.66 (0.15)	0.63 (0.18)
Days 2 to 11	0.66 (0.15)	0.62 (0.18)

18. Secondary Outcome

Title	Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Description	Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Time Frame	Day 1, Days 2 to 11, Days 1 to 11 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.

Arm/Group Title	Bionic Pancreas
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Measure Participants	39
Day 1	7.8 (3.84)
Days 1 to 11	6.9 (2.34)
Days 2 to 11	6.8 (2.4)

19. Secondary Outcome

Title	Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm
Time Frame	Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas
Arm/Group Description	All randomized participants who completed both periods of the study.
Measure Participants	39
Day 1, Overall	101.2 (2.0)
Day 1, Daytime	101.3 (1.6)
Day 1, Nighttime	101.0 (3.9)
Day 2 to 11, Overall	101.9 (5.0)
Day 2 to 11, Daytime	102.0 (5.1)
Day 2 to 11, Nighttime	101.7 (4.9)
Day 1 to 11, Overall	101.8 (4.6)
Day 1 to 11, Daytime	101.9 (4.7)
Day 1 to 11, Nighttime	101.6 (4.5)

20. Secondary Outcome

Title	Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly
Description	Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.
Time Frame	11 days

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only

Arm/Group Title	Bionic Pancreas
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.
Measure Participants	39
Insulin pump Lost Wireless Connectivity	3.9 (2.5)
Glucagon Pump Lost Wireless Connectivity	4.1 (2.4)
CGM Signal Unavailable	3.4 (1.3)

21. Secondary Outcome

Title	Mean Nausea Index Score Using a Visual Analog Scale (VAS)
Description	Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.
Time Frame	Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.79 (1.54)	0.00 (0.00)
Days 1 to 11	0.51 (0.79)	0.05 (0.17)
Days 2 to 11	0.48 (0.82)	0.05 (0.18)
Day 2	0.46 (1.55)	0.08 (0.48)
Day 3	0.56 (1.47)	0.03 (0.16)
Day 4	0.41 (1.19)	0.13 (0.47)
Day 5	0.33 (1.11)	0.00 (0.00)
Day 6	0.56 (1.25)	0.00 (0.00)
Day 7	0.49 (1.47)	0.03 (0.16)
Day 8	0.67 (1.49)	0.08 (0.35)
Day 9	0.44 (1.23)	0.10 (0.50)
Day 10	0.59 (1.62)	0.08 (0.35)
Day 11	0.28 (1.45)	0.03 (0.16)

22. Secondary Outcome

Title	Change From Baseline in Body Weight
Description	The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.
Time Frame	Baseline and Day 12 of each period

Outcome Measure Data

Analysis Population Description

All participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [kilograms]	0.4 (0.95)	0.1 (1.1)

23. Secondary Outcome

Title	Change From Baseline in Hemoglobin
Description	The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.
Time Frame	Baseline and Day 12 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [grams/deciliter (mg/dL)]	-0.16 (0.68)	0.14 (0.68)

24. Secondary Outcome

Title	Number of Participants With Skin Rash
Time Frame	11 days of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Count of Participants [Participants]	0 0%	0 NaN

25. Other Pre-specified Outcome

Title	Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM
Time Frame	11 days

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [percentage of possible values]	96.6 (1.4)	96.3 (1.6)

26. Other Pre-specified Outcome

Title	Number of Unscheduled Infusion Set Replacements
Time Frame	11 days

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Glucagon Unscheduled Infusion Set Replacements	14
Insulin Unscheduled Infusion Set Replacements	11	15

27. Other Pre-specified Outcome

Title	Mean Daily Basal Insulin Dose
Description	Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).
Time Frame	Day 1, Days 2 to 11, each individual day 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.3 (0.1)	0.3 (0.1)
Days 2 to 11	0.3 (0.1)	0.3 (0.002)
Day 2	0.3 (0.1)	0.3 (0.1)
Day 3	0.3 (0.1)	0.3 (0.1)
Day 4	0.3 (0.1)	0.3 (0.1)
Day 5	0.3 (0.1)	0.3 (0.1)
Day 6	0.3 (0.1)	0.3 (0.1)
Day 7	0.3 (0.1)	0.3 (0.1)
Day 8	0.3 (0.1)	0.3 (0.1)
Day 9	0.3 (0.1)	0.3 (0.1)
Day 10	0.3 (0.1)	0.3 (0.1)
Day 11	0.3 (0.1)	0.3 (0.1)

28. Other Pre-specified Outcome

Title	Mean Daily Bolus Insulin Dose
Description	Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).
Time Frame	Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods of the study.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Day 1	0.4 (0.1)	0.3 (0.2)
Days 1 to 11	0.4 (0.1)	0.3 (0.015)
Days 2 to 11	0.4 (0.1)	0.3 (0.015)
Day 2	0.4 (0.1)	0.3 (0.2)
Day 3	0.4 (0.1)	0.3 (0.2)
Day 4	0.4 (0.1)	0.3 (0.3)
Day 5	0.4 (0.1)	0.3 (0.2)
Day 6	0.4 (0.1)	0.3 (0.2)
Day 7	0.4 (0.1)	0.3 (0.2)
Day 8	0.4 (0.1)	0.3 (0.2)
Day 9	0.4 (0.1)	0.3 (0.2)
Day 10	0.4 (0.2)	0.3 (0.2)
Day 11	0.4 (0.1)	0.3 (0.2)

29. Other Pre-specified Outcome

Title	CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads
Description	This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.
Time Frame	11 days

Outcome Measure Data

Analysis Population Description

All randomized participants who completed both periods.

Arm/Group Title	Bionic Pancreas	Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.	Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
Measure Participants	39	39
Mean (Standard Deviation) [percent difference]	19.2 (31.4)	18.0 (28.2)

Adverse Events

Time Frame	Days 1 to 11
Arm/Group Title	Bionic Pancreas		Usual Care
Arm/Group Description	Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 11 days.		Usual Care diabetes management, standard of care for diabetes including use of an insulin pump with or without CGM according to the participant's usual practice, for 11 days.
All Cause Mortality
	Bionic Pancreas		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Serious Adverse Events
	Bionic Pancreas		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Bionic Pancreas		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/41 (100%)		41/41 (100%)
Gastrointestinal disorders
Nausea	21/41 (51.2%)		5/41 (12.2%)
Metabolism and nutrition disorders
Hypoglycemia	41/41 (100%)		41/41 (100%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.