Clincosm LogoSign in Get a demo

Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes

Sponsor
Jaeb Center for Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT00406133
Collaborator
JDRF Artificial Pancreas Project (Other)
451
Enrollment
11
Locations
2
Arms
26.1
Duration (Months)
41
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will follow an identical protocol to that of the first cohort with HbA1c >=7.0%.

The >=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group.

After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous glucose monitor
 Phase 3

Detailed Description

  1. On the day of enrollment, a glycated hemoglobin (HbA1c) level will be obtained, psychosocial questionnaires will be completed, and instructions will be given for use of the real time continuous glucose monitoring device (RT-CGM). The study personnel will supervise the subject or parent inserting the RT-CGM sensor in the clinic and will instruct the subject or parent to insert a second sensor at home as needed. To obtain a baseline assessment of glycemic control and variability, the RT-CGM used during the first week will be blinded so subjects will not be able to view the data from the sensor. The subject will be instructed to complete at least four glucose measurements a day using the study home glucose meter (HGM) and as needed to calibrate the RT-CGM.

  2. The subject will return for a second visit about 10 days after the enrollment visit.

  • Subjects who have been compliant with use of the RT-CGM and HGM will be randomized to one of two treatment groups: RT-CGM Group or Control Group.

  • Compliance will be defined as use of the RT-CGM for at least 6 out of the 7 days prior to the second visit, at least 96 hours of RT-CGM glucose values obtained with at least 24 hours between the hours of 10 p.m. and 6 a.m., and use of the HGM for testing at least 3 times each day prior to the second visit.

  • Subjects who are not compliant will be given another opportunity to complete the baseline requirements at the discretion of the investigator.

  • For the RT-CGM Group, the RT-CGM, HGM, and pump data (if subject uses an insulin pump) will be reviewed and changes will be made to diabetes management as needed. Subjects/parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on RT-CGM and HGM data. Instructions for downloading the RT-CGM and HGM will be provided to subjects with a home computer.

  • For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if subject uses an insulin pump) will be reviewed and changes made in diabetes management as needed. The blinded RT-CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Subjects and parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data.

  1. Both groups will have follow-up visits at 1, 4, 8, 13, 19, and 26 weeks (+/- 1 week) plus one phone contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.

  • Both groups will download device data on a weekly basis (if the subject has a computer). Subjects with email access will be instructed to email the downloaded data to the clinical center prior to each phone contact.

  • For both groups, at each visit, the HGM and pump (if subject uses an insulin pump) will be downloaded and for the RT-CGM Group, the RT-CGM will be downloaded.

  1. In the 13th and 26th weeks, the Control Group will use a blinded RT-CGM for one week. The RT-CGM Group will continue to use the unblinded RT-CGM. The Control Group will return the blinded RT-CGM to the clinic after a week. The data will be reviewed by personnel who are not involved in the care of the subject to determine if additional blinded sensor data are needed. The blinded data will not be reviewed by study personnel for management decisions until the end of the first 6 months of the study.

  2. Following the 26-week visit:

  • Subjects in the RT-CGM Group will continue to use the RT-CGM.

  • Subjects in the Control Group will be provided with a RT-CGM and sensors after the week of blinded use and will have visits after 1 week and 4 weeks, with a phone contact during the first and third weeks.

  • Both groups will have visits after 13 weeks and 26 weeks (study time 9 and 12 months).

Study Design

Study Type:
Interventional
Actual Enrollment :
451 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard intensive glucose monitoring

Patients in the control group were given blood glucose meters and test strips and asked to perform home blood glucose monitoring at least four times daily.
Active Comparator: Continuous Glucose Monitoring (CGM)

Patients in the CGM group were instructed to use the CGM device on a daily basis and to verify the accuracy of the glucose measurement with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).

Device: Continuous glucose monitor
Daily use of a continuous glucose monitor
Other Names:
  • Abbott FreeStyle Navigator
  • DexCom SEVEN
  • Medtronic Paradigm REAL-Time

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) [Baseline and 26 weeks]

      The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).

    2. Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.

    Secondary Outcome Measures

    1. Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) [Baseline and 26 weeks]

      Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort

    2. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) [Baseline and 26 weeks]

      Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    3. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) [Baseline and 26 weeks]

      Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    4. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort [Baseline and 26 weeks]

      Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    5. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)

    6. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)

    7. Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      Glucose variability was assessed by computing the absolute rate of change.

    8. Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort) [Baseline and 26 weeks]

      The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.

    9. Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    10. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    11. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort [Baseline and 26 weeks]

      Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.

    12. Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)

    13. Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Glucose variability was assessed by computing the absolute rate of change.

    14. Quality of Life [26 weeks]

      Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.

    15. Cost-effectiveness of CGM. [26 weeks]

      Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group

    16. QALW [26 weeks]

      Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.

    17. Total Costs: Direct and Indirect Costs [26 weeks]

      Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09-2042/DC1 (Table 1).

    Other Outcome Measures

    1. Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.

    2. Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.

    3. Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.

    4. Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.

    5. 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) [Baseline and 26 weeks]

      A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.

    6. Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.

    7. Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.

    8. 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%) [Baseline and 26 weeks]

      Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year

    • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

    • Age >8 years

    • Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and <7.0% for the secondary cohort

    • The DCA2000 or comparable point of care device will be used to assess eligibility.

    • Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) and has been stable for the last two months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)

    • Subjects using premixed fixed doses of insulin at the time of enrollment will not be eligible

    • Subject (and parent/guardian for children) understands the study protocol and agrees to comply with it

    • Subjects >9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish

    • This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages.

    • Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions in Spanish and has a User Guide in Spanish is available.

    • No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center.

    • Informed Consent Form signed by the subject (or parent/guardian if subject is a minor, with subject signing the Child Assent Form)

    Exclusion Criteria:

    • The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.

    • The presence of any of the following diseases:

    • Asthma if treated with systemic or inhaled corticosteroids in the last 6 months

    • Cystic fibrosis

    • Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment

    • Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for either the subject or the subject's primary care giver).

    • Home use of RT-CGM in past 6 months

    • Use of a CGMS or GlucoWatch does not exclude subjects from enrollment

    • Participation in an intervention study (including psychological studies) in past 6 weeks.

    • Another member of the same household is participating in this study.

    • For females, pregnant or intending to become pregnant during the next year Pregnancy is an exclusion because of uncertainty about the lag between interstitial fluid glucose and blood glucose during pregnancy, which might affect the accuracy of the sensor. Subjects who become pregnant during the study will be discontinued from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Beverly Hills California United States 90211
    2 Kaiser Permanente San Diego California United States 92111
    3 Stanford University Stanford California United States 94305
    4 University of Colorado Aurora Colorado United States 80010
    5 Yale University School of Medicine New Haven Connecticut United States 06520
    6 Nemours Children's Clinic Jacksonville Florida United States 32207
    7 Atlanta Diabetes Associates Atlanta Georgia United States 30309
    8 Children's Hospital of Iowa Iowa City Iowa United States 52242
    9 Joslin Diabetes Center - Adults Boston Massachusetts United States 02215
    10 Joslin Diabetes Center - Children Boston Massachusetts United States 02215
    11 University of Washington Seattle Washington United States 98105

    Sponsors and Collaborators

    • Jaeb Center for Health Research
    • JDRF Artificial Pancreas Project

    Investigators

    • Study Director: Roy W Beck, MD, PhD, Jaeb Center for Health Research
    • Study Chair: Lori Laffel, MD, Joslin Diabetes Center Pediatric Section
    • Study Chair: William V. Tamborlane, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00406133
    Other Study ID Numbers:
    • 2006-2402
    First Posted:
    Dec 4, 2006
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from within the patient population of the study clinical centers.
    Pre-assignment Detail Participants completed a run-in phase wearing a blinded continuous glucose monitoring (CGM) device. Eligibility required that a sensor be worn for six out of seven days prior to randomization, with a minimum of 96 hours of glucose values with at least 24 hours overnight, and home blood glucose monitoring be performed at least three times daily.
    Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
    Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care
    Period Title: Phase 1 (First 26 Week Period)
    STARTED 165 157 67 62
    COMPLETED 162 155 67 60
    NOT COMPLETED 3 2 0 2
    Period Title: Phase 1 (First 26 Week Period)
    STARTED 159 155 67 60
    COMPLETED 157 152 67 60
    NOT COMPLETED 2 3 0 0

    Baseline Characteristics

    Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group Total
    Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care Total of all reporting groups
    Overall Participants 165 157 67 62 451
    Age, Customized (participants) [Number]
    8-14 years
    56
    33.9%
    58
    36.9%
    18
    26.9%
    11
    17.7%
    143.0
    31.7%
    15-24 years
    57
    34.5%
    53
    33.8%
    15
    22.4%
    18
    29%
    143.0
    31.7%
    >=25 years
    52
    31.5%
    46
    29.3%
    34
    50.7%
    33
    53.2%
    165.0
    36.6%
    Sex: Female, Male (Count of Participants)
    Female
    87
    52.7%
    93
    59.2%
    36
    53.7%
    32
    51.6%
    248
    55%
    Male
    78
    47.3%
    64
    40.8%
    31
    46.3%
    30
    48.4%
    203
    45%
    Race/Ethnicity, Customized (participants) [Number]
    Non-Hispanic White
    150
    90.9%
    146
    93%
    63
    94%
    58
    93.5%
    417.0
    92.5%
    Other
    15
    9.1%
    11
    7%
    4
    6%
    4
    6.5%
    34.0
    7.5%
    College graduate (subject or primary care giver) (participants) [Number]
    College graduate
    125
    75.8%
    125
    79.6%
    58
    86.6%
    55
    88.7%
    363.0
    80.5%
    Other
    40
    24.2%
    32
    20.4%
    9
    13.4%
    7
    11.3%
    88.0
    19.5%
    Insulin modality (participants) [Number]
    Pump
    128
    77.6%
    128
    81.5%
    62
    92.5%
    49
    79%
    367.0
    81.4%
    Multiple daily injections
    37
    22.4%
    29
    18.5%
    5
    7.5%
    13
    21%
    84.0
    18.6%
    One or more severe hypoglycemic events in last six months (participants) [Number]
    One or more events
    14
    8.5%
    10
    6.4%
    7
    10.4%
    7
    11.3%
    38.0
    8.4%
    No events
    151
    91.5%
    147
    93.6%
    60
    89.6%
    55
    88.7%
    413.0
    91.6%
    Duration of diabetes (years) [Mean (Standard Deviation) ]
    8-14 years
    6.2
    (3.1)
    5.3
    (2.8)
    4.9
    (2.6)
    4.4
    (3.2)
    5.5
    (3.0)
    15-24 years
    9.5
    (4.8)
    8.8
    (4.0)
    8.7
    (5.3)
    8.1
    (4.5)
    9.0
    (4.5)
    >=25 years
    23.6
    (10.6)
    21.8
    (10.4)
    25.6
    (16.6)
    28.6
    (12.7)
    24.5
    (12.6)
    Glycated hemoglobin (HbA1c) (percent) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percent]
    7.9
    (0.7)
    7.8
    (0.7)
    6.4
    (0.5)
    6.5
    (0.3)
    7.4
    (0.9)

    Outcome Measures

    1. Primary Outcome
    Title Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)
    Description The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    -0.37
    (0.90)
    -0.22
    (0.54)
    15-24 years
    -0.18
    (0.65)
    -0.21
    (0.61)
    >=25 years
    -0.50
    (0.56)
    0.02
    (0.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.29
    Comments A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05. P value is for age 8-14 group.
    Method ANCOVA
    Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.52
    Comments A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05. P value for age 15-24 group.
    Method ANCOVA
    Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05. P value is for age >=25 group.
    Method ANCOVA
    Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
    2. Primary Outcome
    Title Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)
    Description The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [minutes/day]
    54
    91
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments P-value was for the comparison of RT-CGM group and Control group.
    Method ANCOVA
    Comments Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    3. Secondary Outcome
    Title Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
    Description Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (>=1 Severe hypoglycemic event)
    4
    6
    15-24 years (>=1 Severe hypoglycemic event)
    3
    5
    >=25 years (>=1 Severe hypoglycemic event)
    5
    4
    8-14 years (>=1 Severe hypo with seizure or coma)
    0
    0
    15-24 years (>=1 Severe hypo with seizure or coma)
    1
    3
    >=25 years (>=1 Severe hypo with seizure or coma)
    1
    1
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.74
    Comments P-value is for N(%) of subjects with >=1 severe hypo event in the 8-14 year age group.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments P-value is for N(%) of subjects with >=1 severe hypo event in the 15-24 year age group.
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0
    Comments P-value is for N(%) of subjects with >=1 severe hypo event in the >=25 year age group.
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.74
    Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 8-14 year age group.
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 15-24 year age group.
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0
    Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the >=25 year age group.
    Method Fisher Exact
    Comments
    4. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
    Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    646
    (179)
    710
    (187)
    8-14 years (26 Weeks)
    750
    (215)
    746
    (223)
    15-24 years (Baseline)
    691
    (208)
    697
    (201)
    15-24 years (26 Weeks)
    761
    (188)
    761
    (200)
    >=25 years (Baseline)
    854
    (202)
    811
    (226)
    >=25 years (26 Weeks)
    986
    (189)
    840
    (165)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.53
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.79
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments
    5. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
    Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    745
    (200)
    671
    (206)
    8-14 years (26 Weeks)
    643
    (231)
    635
    (240)
    15-24 years (Baseline)
    650
    (227)
    641
    (198)
    15-24 years (26 Weeks)
    591
    (226)
    591
    (203)
    >=25 years (Baseline)
    497
    (216)
    549
    (248)
    >=25 years (26 Weeks)
    394
    (200)
    519
    (185)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.58
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.85
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    6. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
    Description Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    343
    (177)
    282
    (151)
    8-14 years (26 Weeks)
    242
    (167)
    268
    (172)
    15-24 years (Baseline)
    271
    (162)
    265
    (157)
    15-24 years (26 Weeks)
    215
    (154)
    242
    (187)
    >=25 years (Baseline)
    149
    (112)
    181
    (150)
    >=25 years (26 Weeks)
    101
    (116)
    161
    (103)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.44
    Comments P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    7. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
    Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    49
    (68)
    59
    (67)
    8-14 years (26 Weeks)
    47
    (59)
    59
    (60)
    15-24 years (Baseline)
    99
    (79)
    102
    (93)
    15-24 years (26 Weeks)
    88
    (88)
    88
    (79)
    >=25 years (Baseline)
    89
    (128)
    80
    (71)
    >=25 years (26 Weeks)
    60
    (54)
    81
    (89)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.29
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.79
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    8. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
    Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    17
    (39)
    18
    (34)
    8-14 years (26 Weeks)
    10
    (21)
    13
    (22)
    15-24 years (Baseline)
    37
    (49)
    42
    (61)
    15-24 years (26 Weeks)
    29
    (48)
    31
    (43)
    >=25 years (Baseline)
    32
    (86)
    22
    (30)
    >= 25 years (26 Weeks)
    11
    (19)
    23
    (37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.50
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.99
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    9. Secondary Outcome
    Title Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
    Description Glucose variability was assessed by computing the absolute rate of change.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years (Baseline)
    0.84
    (0.18)
    0.83
    (0.17)
    8-14 years (26 Weeks)
    0.82
    (0.21)
    0.83
    (0.21)
    15-24 years (Baseline)
    0.85
    (0.25)
    0.86
    (0.17)
    15-24 years (26 Weeks)
    0.84
    (0.21)
    0.87
    (0.21)
    >=25 years (Baseline)
    0.73
    (0.18)
    0.72
    (0.18)
    >=25 years (26 Weeks)
    0.68
    (0.15)
    0.74
    (0.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Glucose variability was assessed by computing the absolute rate of change.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.66
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
    Method ANCOVA
    Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
    10. Secondary Outcome
    Title Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)
    Description The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 67 62
    Mean (Standard Deviation) [Percent]
    0.02
    (0.45)
    0.33
    (0.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments Adjusted for baseline A1c and clinical center.
    11. Secondary Outcome
    Title Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
    Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [minutes/day]
    1063
    949
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    Method ANCOVA
    Comments Adjusted for baseline value, clinical center and type of continuous glucose monitor.
    12. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
    Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [minutes/day]
    283
    341
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments P-value representative of 13 and 26 weeks combined.
    Method ANCOVA
    Comments
    13. Other Pre-specified Outcome
    Title Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
    Description A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    16
    9.7%
    7
    4.5%
    15-24 years
    8
    4.8%
    5
    3.2%
    >=25 years
    13
    7.9%
    2
    1.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments P-value for the 8-14 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.46
    Comments P-value for the 15-24 year age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value for the >=25 year age group
    Method Regression, Logistic
    Comments
    14. Other Pre-specified Outcome
    Title Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
    Description A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    5
    3%
    2
    1.3%
    15-24 years
    2
    1.2%
    2
    1.3%
    >=25 years
    0
    0%
    1
    0.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.24
    Comments P-value for 8-14 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.98
    Comments P-value for the 15-24 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments P-value for the >=25 year old age group
    Method Regression, Logistic
    Comments
    15. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort
    Description Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [minutes/day]
    48
    82
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments P-value representative of 13 and 26 weeks combined
    Method ANCOVA
    Comments
    16. Secondary Outcome
    Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)
    Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [minutes/day]
    4
    8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments P-value representative of 13 and 26 weeks combined.
    Method ANCOVA
    Comments
    17. Secondary Outcome
    Title Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)
    Description Glucose variability was assessed by computing the absolute rate of change.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 66 60
    Median (Inter-Quartile Range) [mg/dl/min]
    0.66
    0.66
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Glucose variability was assessed by computing the absolute rate of change.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments P-value representative of 13 and 26 weeks combined.
    Method ANCOVA
    Comments
    18. Secondary Outcome
    Title Quality of Life
    Description Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%.
    Arm/Group Title CGM Group Control Group
    Arm/Group Description Participants who were randomized to CGM use Participants randomized to SMBG
    Measure Participants 120 106
    Mean (Standard Deviation) [units on a scale]
    33.3
    (11.5)
    36.0
    (13.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.04
    Comments Nominal p-value not adjusted for multiple comparisons
    Method ANCOVA
    Comments
    19. Secondary Outcome
    Title Cost-effectiveness of CGM.
    Description Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    Baseline A1c<7%.
    Arm/Group Title CGM Group Control Group
    Arm/Group Description Participants randomized to CGM Use Participants randomized to SMBG
    Measure Participants 67 62
    Number [dollars per QALY]
    70904
    49438
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups: (mean cost[CGM] - mean cost [control]) / (mean QALY[CGM] - mean QALY[SMBG]). Units are dollars per QALY.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Ratio of treatment differences
    Estimated Value 408148
    Confidence Interval (2-Sided) 95%
    -176644 to 3475108
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Other Pre-specified Outcome
    Title Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
    Description A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    30
    18.2%
    18
    11.5%
    15-24 years
    20
    12.1%
    19
    12.1%
    >=25 years
    24
    14.5%
    5
    3.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments P-value for the 8-14 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.57
    Comments P-value for 15-24 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for the >=25 year old age group
    Method Regression, Logistic
    Comments
    21. Other Pre-specified Outcome
    Title Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
    Description A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HBA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    12
    7.3%
    7
    4.5%
    15-24 years
    7
    4.2%
    7
    4.5%
    >=25 years
    0
    0%
    5
    3.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments P-value for 8-14 year age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.84
    Comments P-value for 15-24 year old age group.
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments P-value for >=25 year old age group.
    Method Regression, Logistic
    Comments
    22. Other Pre-specified Outcome
    Title 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
    Description A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    15
    9.1%
    7
    4.5%
    15-24 years
    8
    4.8%
    9
    5.7%
    >= 25 years
    17
    10.3%
    4
    2.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments P-value for 8-14 year age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.80
    Comments P-value for 14-24 year age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments P-value for >=25 year age group
    Method Regression, Logistic
    Comments
    23. Post-Hoc Outcome
    Title 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
    Description A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c >=7.0% who were randomized to CGM use Participants with baseline HbA1c >=7.0% who were randomized to standard care
    Measure Participants 165 157
    8-14 years
    14
    8.5%
    6
    3.8%
    15-24 years
    7
    4.2%
    7
    4.5%
    >=25 years
    15
    9.1%
    3
    1.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments P-value for the 8-14 year age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.67
    Comments P-value for the 15-24 year old age group
    Method Regression, Logistic
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments P-value for the >=25 year old age group
    Method Regression, Logistic
    Comments
    24. Other Pre-specified Outcome
    Title Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
    Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 67 62
    Number [participants]
    21
    12.7%
    3
    1.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    25. Other Pre-specified Outcome
    Title Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
    Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 67 62
    Number [participants]
    19
    11.5%
    31
    19.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Regression, Logistic
    Comments
    26. Other Pre-specified Outcome
    Title 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)
    Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
    Time Frame Baseline and 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed according to the intention-to-treat principle.
    Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
    Arm/Group Description Participants with baseline HbA1c <7.0% who were randomized to CGM use Participants with baseline HbA1c <7.0% who were randomized to standard care
    Measure Participants 67 62
    Number [participants]
    59
    35.8%
    38
    24.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
    Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    27. Secondary Outcome
    Title QALW
    Description Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    Baseline A1c <7.0%
    Arm/Group Title CGM Group Control Group
    Arm/Group Description Participants who were randomized to CGM use Participants randomized to SMBG
    Measure Participants 67 62
    Mean (Standard Error) [weeks]
    23.23
    (0.81)
    21.84
    (0.66)
    28. Secondary Outcome
    Title Total Costs: Direct and Indirect Costs
    Description Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09-2042/DC1 (Table 1).
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    Baseline A1c < 7.0%
    Arm/Group Title CGM Group Control Group
    Arm/Group Description Participants who were randomized to CGM use Participants randomized to SMBG
    Measure Participants 67 62
    Mean (Standard Error) [dollars]
    31675
    (6292)
    20764
    (4351)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
    Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care
    All Cause Mortality
    Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/165 (4.2%) 12/157 (7.6%) 7/67 (10.4%) 7/62 (11.3%)
    Endocrine disorders
    Severe Hypoglycemia 7/165 (4.2%) 7 12/157 (7.6%) 12 7/67 (10.4%) 7 7/62 (11.3%) 7
    Other (Not Including Serious) Adverse Events
    Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/165 (2.4%) 3/157 (1.9%) 0/67 (0%) 0/62 (0%)
    Endocrine disorders
    Diabetic ketoacidosis 0/165 (0%) 0 1/157 (0.6%) 1 0/67 (0%) 0 0/62 (0%) 0
    General disorders
    Seizure not caused by hypoglycemia 1/165 (0.6%) 1 0/157 (0%) 0 0/67 (0%) 0 0/62 (0%) 0
    Injury, poisoning and procedural complications
    Dizziness during blood draw 0/165 (0%) 0 1/157 (0.6%) 1 0/67 (0%) 0 0/62 (0%) 0
    Kidney laceration 0/165 (0%) 0 1/157 (0.6%) 1 0/67 (0%) 0 0/62 (0%) 0
    Psychiatric disorders
    Anxiety and depression 1/165 (0.6%) 1 0/157 (0%) 0 0/67 (0%) 0 0/62 (0%) 0
    Skin and subcutaneous tissue disorders
    Cellulitis related to sensor use 2/165 (1.2%) 2 0/157 (0%) 0 0/67 (0%) 0 0/62 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Roy W. Beck, M.D., Ph.D., Director
    Organization Jaeb Center for Health Research
    Phone 813-975-8690
    Email rbeck@jaeb.org
    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00406133
    Other Study ID Numbers:
    • 2006-2402
    First Posted:
    Dec 4, 2006
    Last Update Posted:
    Apr 14, 2017
    Last Verified:
    Mar 1, 2017