CompletedNCT00406133Updated Apr 14, 2017Results posted

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

A Phase 3 interventional study of Continuous glucose monitor in Type 1 Diabetes, sponsored by Jaeb Center for Health Research. Completed at 11 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 451
Allocation: Randomized
Ages: 8 Years and older
Sex: All

Study 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.

Read the detailed description

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.
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.
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.
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.
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).

Conditions studied

Type 1 Diabetes

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 451 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 8 Years and older
Sexes eligible: 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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 451 participants (actual)

Study arms

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

Interventions

DeviceContinuous glucose monitor
Daily use of a continuous glucose monitor
Also known as: Abbott FreeStyle Navigator, DexCom SEVEN, Medtronic Paradigm REAL-Time

What researchers measure

Primary outcomes

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)
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
Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)
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

Secondary outcomes

Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c \>=7.0% cohort
Time frame: Baseline and 26 weeks
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
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
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
Glucose variability was assessed by computing the absolute rate of change.
Time frame: Baseline and 26 weeks
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)
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
Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort
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
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)
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
Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)
Glucose variability was assessed by computing the absolute rate of change.
Time frame: Baseline and 26 weeks
Quality of Life
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
Cost-effectiveness of CGM.
Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group
Time frame: 26 weeks
QALW
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
Total Costs: Direct and Indirect Costs
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

Other outcomes

Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
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
Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
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
Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
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
Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
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
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
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
Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
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
Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
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
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)
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

Results

Posted Sep 2, 2009

Participant flow

Participants were recruited from within the patient population of the study clinical centers.

Phase 1 (First 26 Week Period)

Participant flow — Phase 1 (First 26 Week Period)
Milestone	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
Started	165	157	67	62
Completed	162	155	67	60
Not completed	3	2	0	2

Phase 2 (Second 26 Week Period)

Participant flow — Phase 2 (Second 26 Week Period)
Milestone	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
Started	159	155	67	60
Completed	157	152	67	60
Not completed	2	3	0	0

Outcome measures

PrimaryChange 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)

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
Reported as:: Mean · Percent

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)
Percent	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.29 (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.)Performed in each age group and adjusted for the baseline A1c and clinical center.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.52 (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.)Performed in each age group and adjusted for the baseline A1c and clinical center.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = <0.001 (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.)Performed in each age group and adjusted for the baseline A1c and clinical center.

PrimaryTime With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)

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
Reported as:: Median · minutes/day

Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)	54 (28 to 108)	91 (27 to 188)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.16 (P-value was for the comparison of RT-CGM group and Control group.)Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.

SecondarySevere Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)

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

Time frame:: Baseline and 26 weeks
Reported as:: Number · subjects with event

Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
subjects with event	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 0.74 (P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 0.48 (P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 1.0 (P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 0.74 (P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 0.48 (P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Fisher Exact · p = 1.0 (P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.)

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)

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
Reported as:: Mean · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.53 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.79 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = <0.001 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)

Time frame:: Baseline and 26 weeks
Reported as:: Mean · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.58 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.85 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.002 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort

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
Reported as:: Mean · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.18 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.44 (P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = <0.001 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Mean · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
minutes/day	Primary Cohort RT-CGM Group	Primary Cohort Control Group
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

Primary Cohort RT-CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.29 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort RT-CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.79 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort RT-CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.41 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Mean · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.50 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.99 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.10 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.

SecondaryGlucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)

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

Time frame:: Baseline and 26 weeks
Reported as:: Mean · Mean mg/dl/minute

Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
Mean mg/dl/minute	Primary Cohort CGM Group	Primary Cohort Control Group
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

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.66 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.48 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.07 (P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.)Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.

SecondaryChange 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)

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
Reported as:: Mean · Percent

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)
Percent	Primary Cohort CGM Group	Primary Cohort Control Group
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)	0.02 ± 0.45	0.33 ± 0.43

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = <0.001Adjusted for baseline A1c and clinical center.

SecondaryMinutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)

Time frame:: Baseline and 26 weeks
Reported as:: Median · minutes/day

Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)	1063 (948 to 1185)	949 (784 to 1106)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = <0.001 (Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.)Adjusted for baseline value, clinical center and type of continuous glucose monitor.

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)

Time frame:: Baseline and 26 weeks
Reported as:: Median · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)	283 (173 to 423)	341 (232 to 502)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.03 (P-value representative of 13 and 26 weeks combined.)

Other pre-specifiedRelative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	16	7
15-24 years	8	5
>=25 years	13	2

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.04 (P-value for the 8-14 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.46 (P-value for the 15-24 year age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.003 (P-value for the \>=25 year age group)

Other pre-specifiedRelative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	5	2
15-24 years	2	2
>=25 years	0	1

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.24 (P-value for 8-14 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.98 (P-value for the 15-24 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.48 (P-value for the \>=25 year old age group)

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort

Time frame:: Baseline and 26 weeks
Reported as:: Median · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort	48 (11 to 103)	82 (22 to 149)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.005 (P-value representative of 13 and 26 weeks combined)

SecondaryMinutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)

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
Reported as:: Median · minutes/day

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)
minutes/day	Primary Cohort CGM Group	Primary Cohort Control Group
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)	4 (0 to 15)	8 (0 to 55)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.05 (P-value representative of 13 and 26 weeks combined.)

SecondaryAbsolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)

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

Time frame:: Baseline and 26 weeks
Reported as:: Median · mg/dl/min

Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)
mg/dl/min	Primary Cohort CGM Group	Primary Cohort Control Group
Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)	0.66 (0.53 to 0.76)	0.66 (0.54 to 0.87)

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · ANCOVA · p = 0.39 (P-value representative of 13 and 26 weeks combined.)

SecondaryQuality of Life

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
Reported as:: Mean · units on a scale

Quality of Life
units on a scale	CGM Group	Control Group
Quality of Life	33.3 ± 11.5	36.0 ± 13.6

Statistical analysis

CGM Group vs Control Group · ANCOVA · p = 0.04 (Nominal p-value not adjusted for multiple comparisons)

SecondaryCost-effectiveness of CGM.

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

Time frame:: 26 weeks
Reported as:: Number · dollars per QALY

Cost-effectiveness of CGM.
dollars per QALY	CGM Group	Control Group
Cost-effectiveness of CGM.	70904	49438

Statistical analysis

CGM Group vs Control Group · Ratio of treatment differences: 408148 · 95% CI -176644 to 3475108

Other pre-specifiedRelative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	30	18
15-24 years	20	19
>=25 years	24	5

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.009 (P-value for the 8-14 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.57 (P-value for 15-24 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = <0.001 (P-value for the \>=25 year old age group)

Other pre-specifiedRelative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	12	7
15-24 years	7	7
>=25 years	0	5

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.18 (P-value for 8-14 year age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.84 (P-value for 15-24 year old age group.)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.02 (P-value for \>=25 year old age group.)

Other pre-specified26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	15	7
15-24 years	8	9
>= 25 years	17	4

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.01 (P-value for 8-14 year age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.80 (P-value for 14-24 year age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.005 (P-value for \>=25 year age group)

Post-hoc26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)

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
Reported as:: Number · participants

26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
8-14 years	14	6
15-24 years	7	7
>=25 years	15	3

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.02 (P-value for the 8-14 year age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.67 (P-value for the 15-24 year old age group)
Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.006 (P-value for the \>=25 year old age group)

Other pre-specifiedDecrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)

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
Reported as:: Number · participants

Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)	21	3

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = <0.001

Other pre-specifiedIncrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)

Time frame:: Baseline and 26 weeks
Reported as:: Number · participants

Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)	19	31

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = 0.002

Other pre-specified26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)

Time frame:: Baseline and 26 weeks
Reported as:: Number · participants

26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)
participants	Primary Cohort CGM Group	Primary Cohort Control Group
26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)	59	38

Statistical analysis

Primary Cohort CGM Group vs Primary Cohort Control Group · Regression, Logistic · p = <0.001

SecondaryQALW

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
Reported as:: Mean · weeks

QALW
weeks	CGM Group	Control Group
QALW	23.23 ± 0.81	21.84 ± 0.66

SecondaryTotal Costs: Direct and Indirect Costs

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
Reported as:: Mean · dollars

Total Costs: Direct and Indirect Costs
dollars	CGM Group	Control Group
Total Costs: Direct and Indirect Costs	31675 ± 6292	20764 ± 4351

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Primary Cohort RT-CGM Group	—	7/165 (4.2%)	4/165 (2.4%)
Primary Cohort Control Group	—	12/157 (7.6%)	3/157 (1.9%)
Secondary Cohort RT-CGM Group	—	7/67 (10.4%)	0/67 (0%)
Secondary Cohort Control Group	—	7/62 (11.3%)	0/62 (0%)

Most frequent serious events

Most frequent serious events
Event	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
Severe HypoglycemiaEndocrine disorders	7/165	12/157	7/67	7/62

Most frequent other events

Most frequent other events
Event	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
Cellulitis related to sensor useSkin and subcutaneous tissue disorders	2/165	0/157	0/67	0/62
Diabetic ketoacidosisEndocrine disorders	0/165	1/157	0/67	0/62
Dizziness during blood drawInjury, poisoning and procedural complications	0/165	1/157	0/67	0/62
Kidney lacerationInjury, poisoning and procedural complications	0/165	1/157	0/67	0/62
Anxiety and depressionPsychiatric disorders	1/165	0/157	0/67	0/62
Seizure not caused by hypoglycemiaGeneral disorders	1/165	0/157	0/67	0/62

Baseline characteristics

Age, Customized
Age, Customized(participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
8-14 years	56	58	18	11	143.0
15-24 years	57	53	15	18	143.0
>=25 years	52	46	34	33	165.0

Sex: Female, Male
Sex: Female, Male(Participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
Female	87	93	36	32	248
Male	78	64	31	30	203

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
Non-Hispanic White	150	146	63	58	417.0
Other	15	11	4	4	34.0

College graduate (subject or primary care giver)
College graduate (subject or primary care giver)(participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
College graduate	125	125	58	55	363.0
Other	40	32	9	7	88.0

Insulin modality
Insulin modality(participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
Pump	128	128	62	49	367.0
Multiple daily injections	37	29	5	13	84.0

One or more severe hypoglycemic events in last six months
One or more severe hypoglycemic events in last six months(participants)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
One or more events	14	10	7	7	38.0
No events	151	147	60	55	413.0

Duration of diabetes
Duration of diabetes(years)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
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)
Glycated hemoglobin (HbA1c)(percent)	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
Mean	7.9 ± 0.7	7.8 ± 0.7	6.4 ± 0.5	6.5 ± 0.3	7.4 ± 0.9

Study locations

11 sites

University of Southern California
Beverly Hills, California 90211, United States
Kaiser Permanente
San Diego, California 92111, United States
Stanford University
Stanford, California 94305, United States
University of Colorado
Aurora, Colorado 80010, United States
Yale University School of Medicine
New Haven, Connecticut 06520, United States
Nemours Children's Clinic
Jacksonville, Florida 32207, United States
Atlanta Diabetes Associates
Atlanta, Georgia 30309, United States
Children's Hospital of Iowa
Iowa City, Iowa 52242, United States
Joslin Diabetes Center - Adults
Boston, Massachusetts 02215, United States
Joslin Diabetes Center - Children
Boston, Massachusetts 02215, United States
University of Washington
Seattle, Washington 98105, United States

References and documents

Publications

JDRF CGM Study Group. JDRF randomized clinical trial to assess the efficacy of real-time continuous glucose monitoring in the management of type 1 diabetes: research design and methods. Diabetes Technol Ther. 2008 Aug;10(4):310-21. doi: 10.1089/dia.2007.0302. PubMed 18828243 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8. PubMed 18779236 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8. PubMed 19429875 ↗
Wilson DM, Xing D, Cheng J, Beck RW, Hirsch I, Kollman C, Laffel L, Lawrence JM, Mauras N, Ruedy KJ, Tsalikian E, Wolpert H; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Persistence of individual variations in glycated hemoglobin: analysis of data from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Trial. Diabetes Care. 2011 Jun;34(6):1315-7. doi: 10.2337/dc10-1661. Epub 2011 Apr 19. PubMed 21505208 ↗
Xing D, Kollman C, Beck RW, Tamborlane WV, Laffel L, Buckingham BA, Wilson DM, Weinzimer S, Fiallo-Scharer R, Ruedy KJ; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Optimal sampling intervals to assess long-term glycemic control using continuous glucose monitoring. Diabetes Technol Ther. 2011 Mar;13(3):351-8. doi: 10.1089/dia.2010.0156. Epub 2011 Feb 7. PubMed 21299401 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fiallo-Scharer R, Cheng J, Beck RW, Buckingham BA, Chase HP, Kollman C, Laffel L, Lawrence JM, Mauras N, Tamborlane WV, Wilson DM, Wolpert H. Factors predictive of severe hypoglycemia in type 1 diabetes: analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset. Diabetes Care. 2011 Mar;34(3):586-90. doi: 10.2337/dc10-1111. Epub 2011 Jan 25. PubMed 21266651 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Wilson DM, Xing D, Beck RW, Block J, Bode B, Fox LA, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Steffes M, Tamborlane WV. Hemoglobin A1c and mean glucose in patients with type 1 diabetes: analysis of data from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Care. 2011 Mar;34(3):540-4. doi: 10.2337/dc10-1054. Epub 2011 Jan 25. PubMed 21266647 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Prolonged nocturnal hypoglycemia is common during 12 months of continuous glucose monitoring in children and adults with type 1 diabetes. Diabetes Care. 2010 May;33(5):1004-8. doi: 10.2337/dc09-2081. Epub 2010 Mar 3. PubMed 20200306 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care. 2010 Jan;33(1):17-22. doi: 10.2337/dc09-1502. Epub 2009 Oct 16. PubMed 19837791 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Buckingham B, Miller K, Wolpert H, Xing D, Block JM, Chase HP, Hirsch I, Kollman C, Laffel L, Lawrence JM, Milaszewski K, Ruedy KJ, Tamborlane WV. Factors predictive of use and of benefit from continuous glucose monitoring in type 1 diabetes. Diabetes Care. 2009 Nov;32(11):1947-53. doi: 10.2337/dc09-0889. Epub 2009 Aug 12. PubMed 19675206 ↗
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Bode B, Beck RW, Xing D, Gilliam L, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Tamborlane WV, Weinzimer S, Wolpert H. Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2047-9. doi: 10.2337/dc09-0846. Epub 2009 Aug 12. PubMed 19675193 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00406133
Lead sponsor: Jaeb Center for Health Research
Collaborators: JDRF Artificial Pancreas Project
Responsible party: Sponsor
First posted: Dec 4, 2006
Start date: Dec 2006
Primary completion: Jul 2008
Completion: Feb 2009
Results posted: Sep 2, 2009
Last update: Apr 14, 2017

Study contacts

Roy W Beck, MD, PhD

study director · Jaeb Center for Health Research

Lori Laffel, MD

study chair · Joslin Diabetes Center Pediatric Section

William V. Tamborlane, MD

study chair · Yale University

Oversight

Data monitoring committee: Yes

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

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