Type 1 Diabetes
Conditions
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.
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. 3. 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. 4. 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. 5. 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).
Interventions
DEVICEContinuous glucose monitor
Daily use of a continuous glucose monitor
Sponsors
JDRF Artificial Pancreas Project
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
| 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) |
| 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. |
| 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. |
| Cost-effectiveness of CGM. | 26 weeks | Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group |
| 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. |
| 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). |
| 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 |
| 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. |
| 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. |
| 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. |
| 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) |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from within the patient population of the study clinical centers.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Primary Cohort RT-CGM Group Participants with baseline A1c \>=7.0% who were randomized to CGM use | 165 |
| Primary Cohort Control Group Participants with baseline A1c \>=7.0% who were randomized to standard care | 157 |
| Secondary Cohort RT-CGM Group Participants with baseline A1c \<7.0% who were randomized to CGM use | 67 |
| Secondary Cohort Control Group Participants with baseline A1c \<7.0% who were randomized to standard care | 62 |
| Total | 451 |
Baseline characteristics
| Characteristic | Primary Cohort RT-CGM Group | Total | Secondary Cohort Control Group | Secondary Cohort RT-CGM Group | Primary Cohort Control Group |
|---|---|---|---|---|---|
| Age, Customized 15-24 years | 57 participants | 143.0 participants | 18 participants | 15 participants | 53 participants |
| Age, Customized >=25 years | 52 participants | 165.0 participants | 33 participants | 34 participants | 46 participants |
| Age, Customized 8-14 years | 56 participants | 143.0 participants | 11 participants | 18 participants | 58 participants |
| College graduate (subject or primary care giver) College graduate | 125 participants | 363.0 participants | 55 participants | 58 participants | 125 participants |
| College graduate (subject or primary care giver) Other | 40 participants | 88.0 participants | 7 participants | 9 participants | 32 participants |
| Duration of diabetes 15-24 years | 9.5 years STANDARD_DEVIATION 4.8 | 9.0 years STANDARD_DEVIATION 4.5 | 8.1 years STANDARD_DEVIATION 4.5 | 8.7 years STANDARD_DEVIATION 5.3 | 8.8 years STANDARD_DEVIATION 4 |
| Duration of diabetes >=25 years | 23.6 years STANDARD_DEVIATION 10.6 | 24.5 years STANDARD_DEVIATION 12.6 | 28.6 years STANDARD_DEVIATION 12.7 | 25.6 years STANDARD_DEVIATION 16.6 | 21.8 years STANDARD_DEVIATION 10.4 |
| Duration of diabetes 8-14 years | 6.2 years STANDARD_DEVIATION 3.1 | 5.5 years STANDARD_DEVIATION 3 | 4.4 years STANDARD_DEVIATION 3.2 | 4.9 years STANDARD_DEVIATION 2.6 | 5.3 years STANDARD_DEVIATION 2.8 |
| Glycated hemoglobin (HbA1c) | 7.9 percent STANDARD_DEVIATION 0.7 | 7.4 percent STANDARD_DEVIATION 0.9 | 6.5 percent STANDARD_DEVIATION 0.3 | 6.4 percent STANDARD_DEVIATION 0.5 | 7.8 percent STANDARD_DEVIATION 0.7 |
| Insulin modality Multiple daily injections | 37 participants | 84.0 participants | 13 participants | 5 participants | 29 participants |
| Insulin modality Pump | 128 participants | 367.0 participants | 49 participants | 62 participants | 128 participants |
| One or more severe hypoglycemic events in last six months No events | 151 participants | 413.0 participants | 55 participants | 60 participants | 147 participants |
| One or more severe hypoglycemic events in last six months One or more events | 14 participants | 38.0 participants | 7 participants | 7 participants | 10 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 150 participants | 417.0 participants | 58 participants | 63 participants | 146 participants |
| Race/Ethnicity, Customized Other | 15 participants | 34.0 participants | 4 participants | 4 participants | 11 participants |
| Sex: Female, Male Female | 87 Participants | 248 Participants | 32 Participants | 36 Participants | 93 Participants |
| Sex: Female, Male Male | 78 Participants | 203 Participants | 30 Participants | 31 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 165 | 3 / 157 | 0 / 67 | 0 / 62 |
| serious Total, serious adverse events | 7 / 165 | 12 / 157 | 7 / 67 | 7 / 62 |
Outcome results
Primary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM 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) | >=25 years | -0.50 Percent | Standard Deviation 0.56 |
| Primary Cohort CGM 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) | 8-14 years | -0.37 Percent | Standard Deviation 0.9 |
| Primary Cohort CGM 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) | 15-24 years | -0.18 Percent | Standard Deviation 0.65 |
| 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) | >=25 years | 0.02 Percent | Standard Deviation 0.45 |
| 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) | 8-14 years | -0.22 Percent | Standard Deviation 0.54 |
| 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) | 15-24 years | -0.21 Percent | Standard Deviation 0.61 |
Comparison: 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.p-value: 0.29ANCOVA
p-value: 0.52ANCOVA
p-value: <0.001ANCOVA
Primary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) | 54 minutes/day |
| Primary Cohort Control Group | Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) | 91 minutes/day |
Comparison: 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.p-value: 0.16ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) | 0.66 mg/dl/min |
| Primary Cohort Control Group | Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) | 0.66 mg/dl/min |
Comparison: Glucose variability was assessed by computing the absolute rate of change.p-value: 0.39ANCOVA
Secondary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort CGM 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 Percent | Standard Deviation 0.45 |
| 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) | 0.33 Percent | Standard Deviation 0.43 |
Comparison: Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).p-value: <0.001ANCOVA
Secondary
Cost-effectiveness of CGM.
Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group
Time frame: 26 weeks
Population: Baseline A1c\<7%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort CGM Group | Cost-effectiveness of CGM. | 70904 dollars per QALY |
| Primary Cohort Control Group | Cost-effectiveness of CGM. | 49438 dollars per QALY |
Comparison: 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.95% CI: [-176644, 3475108]
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 0.84 Mean mg/dl/minute | Standard Deviation 0.21 |
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 0.85 Mean mg/dl/minute | Standard Deviation 0.25 |
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 0.73 Mean mg/dl/minute | Standard Deviation 0.18 |
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 0.82 Mean mg/dl/minute | Standard Deviation 0.21 |
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (26 Weeks) | 0.68 Mean mg/dl/minute | Standard Deviation 0.15 |
| Primary Cohort CGM Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 0.84 Mean mg/dl/minute | Standard Deviation 0.18 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (26 Weeks) | 0.74 Mean mg/dl/minute | Standard Deviation 0.21 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 0.83 Mean mg/dl/minute | Standard Deviation 0.17 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 0.86 Mean mg/dl/minute | Standard Deviation 0.17 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 0.87 Mean mg/dl/minute | Standard Deviation 0.21 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 0.72 Mean mg/dl/minute | Standard Deviation 0.18 |
| Primary Cohort Control Group | Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 0.83 Mean mg/dl/minute | Standard Deviation 0.21 |
Comparison: Glucose variability was assessed by computing the absolute rate of change.p-value: 0.66ANCOVA
p-value: 0.48ANCOVA
p-value: 0.07ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) | 283 minutes/day |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) | 341 minutes/day |
Comparison: 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.p-value: 0.03ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (Baseline) | 745 minutes/day | Standard Deviation 200 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (26 Weeks) | 643 minutes/day | Standard Deviation 231 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (Baseline) | 650 minutes/day | Standard Deviation 227 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (26 Weeks) | 591 minutes/day | Standard Deviation 226 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (Baseline) | 497 minutes/day | Standard Deviation 216 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (26 Weeks) | 394 minutes/day | Standard Deviation 200 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (Baseline) | 549 minutes/day | Standard Deviation 248 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (Baseline) | 671 minutes/day | Standard Deviation 206 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (26 Weeks) | 591 minutes/day | Standard Deviation 203 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (26 Weeks) | 635 minutes/day | Standard Deviation 240 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (26 Weeks) | 519 minutes/day | Standard Deviation 185 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (Baseline) | 641 minutes/day | Standard Deviation 198 |
Comparison: 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).p-value: 0.58ANCOVA
p-value: 0.85ANCOVA
p-value: 0.002ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort | 48 minutes/day |
| 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 | 82 minutes/day |
Comparison: 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.p-value: 0.005ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | 15-24 years (Baseline) | 271 minutes/day | Standard Deviation 162 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | >=25 years (26 Weeks) | 101 minutes/day | Standard Deviation 116 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | 15-24 years (26 Weeks) | 215 minutes/day | Standard Deviation 154 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | 8-14 years (26 Weeks) | 242 minutes/day | Standard Deviation 167 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | >=25 years (Baseline) | 149 minutes/day | Standard Deviation 112 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | 8-14 years (Baseline) | 343 minutes/day | Standard Deviation 177 |
| 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 | >=25 years (26 Weeks) | 161 minutes/day | Standard Deviation 103 |
| 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 | 8-14 years (Baseline) | 282 minutes/day | Standard Deviation 151 |
| 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 | 8-14 years (26 Weeks) | 268 minutes/day | Standard Deviation 172 |
| 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 | 15-24 years (Baseline) | 265 minutes/day | Standard Deviation 157 |
| 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 | 15-24 years (26 Weeks) | 242 minutes/day | Standard Deviation 187 |
| 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 | >=25 years (Baseline) | 181 minutes/day | Standard Deviation 150 |
Comparison: 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).p-value: 0.18ANCOVA
p-value: 0.44ANCOVA
p-value: <0.001ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) | 4 minutes/day |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) | 8 minutes/day |
Comparison: 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.p-value: 0.05ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >= 25 years (26 Weeks) | 11 minutes/day | Standard Deviation 19 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 17 minutes/day | Standard Deviation 39 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 10 minutes/day | Standard Deviation 21 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 37 minutes/day | Standard Deviation 49 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 29 minutes/day | Standard Deviation 48 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 32 minutes/day | Standard Deviation 86 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 31 minutes/day | Standard Deviation 43 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >= 25 years (26 Weeks) | 23 minutes/day | Standard Deviation 37 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 42 minutes/day | Standard Deviation 61 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 18 minutes/day | Standard Deviation 34 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 22 minutes/day | Standard Deviation 30 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 13 minutes/day | Standard Deviation 22 |
Comparison: 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).p-value: 0.5ANCOVA
p-value: 0.99ANCOVA
p-value: 0.1ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 88 minutes/day | Standard Deviation 88 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 47 minutes/day | Standard Deviation 59 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 89 minutes/day | Standard Deviation 128 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 99 minutes/day | Standard Deviation 79 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (26 Weeks) | 60 minutes/day | Standard Deviation 54 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 49 minutes/day | Standard Deviation 68 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (26 Weeks) | 81 minutes/day | Standard Deviation 89 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (26 Weeks) | 59 minutes/day | Standard Deviation 60 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (Baseline) | 102 minutes/day | Standard Deviation 93 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years (26 Weeks) | 88 minutes/day | Standard Deviation 79 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | >=25 years (Baseline) | 80 minutes/day | Standard Deviation 71 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years (Baseline) | 59 minutes/day | Standard Deviation 67 |
Comparison: 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).p-value: 0.29ANCOVA
p-value: 0.79ANCOVA
p-value: 0.41ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (26 Weeks) | 761 minutes/day | Standard Deviation 188 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (26 Weeks) | 986 minutes/day | Standard Deviation 189 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (Baseline) | 691 minutes/day | Standard Deviation 208 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (Baseline) | 646 minutes/day | Standard Deviation 179 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (Baseline) | 854 minutes/day | Standard Deviation 202 |
| Primary Cohort CGM Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (26 Weeks) | 750 minutes/day | Standard Deviation 215 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (Baseline) | 811 minutes/day | Standard Deviation 226 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (Baseline) | 697 minutes/day | Standard Deviation 201 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (26 Weeks) | 761 minutes/day | Standard Deviation 200 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (26 Weeks) | 746 minutes/day | Standard Deviation 223 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (26 Weeks) | 840 minutes/day | Standard Deviation 165 |
| Primary Cohort Control Group | Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (Baseline) | 710 minutes/day | Standard Deviation 187 |
Comparison: 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).p-value: 0.53ANCOVA
p-value: 0.79ANCOVA
p-value: <0.001ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Primary Cohort CGM Group | Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%) | 1063 minutes/day |
| 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%) | 949 minutes/day |
Comparison: 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.p-value: <0.001ANCOVA
Secondary
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
Population: Baseline A1c \<7.0%
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort CGM Group | QALW | 23.23 weeks | Standard Error 0.81 |
| Primary Cohort Control Group | QALW | 21.84 weeks | Standard Error 0.66 |
Secondary
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
Population: Participants \>= 18 years of age. Pools participants with baseline HbA1c \<7.0% and \>=7.0%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort CGM Group | Quality of Life | 33.3 units on a scale | Standard Deviation 11.5 |
| Primary Cohort Control Group | Quality of Life | 36.0 units on a scale | Standard Deviation 13.6 |
p-value: 0.04ANCOVA
Secondary
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (>=1 Severe hypoglycemic event) | 4 subjects with event |
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (>=1 Severe hypoglycemic event) | 3 subjects with event |
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (>=1 Severe hypoglycemic event) | 5 subjects with event |
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (>=1 Severe hypo with seizure or coma) | 0 subjects with event |
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (>=1 Severe hypo with seizure or coma) | 1 subjects with event |
| Primary Cohort CGM Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (>=1 Severe hypo with seizure or coma) | 1 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (>=1 Severe hypo with seizure or coma) | 3 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (>=1 Severe hypoglycemic event) | 6 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 8-14 years (>=1 Severe hypo with seizure or coma) | 0 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | 15-24 years (>=1 Severe hypoglycemic event) | 5 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (>=1 Severe hypo with seizure or coma) | 1 subjects with event |
| Primary Cohort Control Group | Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | >=25 years (>=1 Severe hypoglycemic event) | 4 subjects with event |
Comparison: 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.p-value: 0.74Fisher Exact
p-value: 0.48Fisher Exact
p-value: 1Fisher Exact
Comparison: 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.p-value: 0.74Fisher Exact
Comparison: 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.p-value: 0.48Fisher Exact
Comparison: 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.p-value: 1Fisher Exact
Secondary
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
Population: Baseline A1c \< 7.0%
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort CGM Group | Total Costs: Direct and Indirect Costs | 31675 dollars | Standard Error 6292 |
| Primary Cohort Control Group | Total Costs: Direct and Indirect Costs | 20764 dollars | Standard Error 4351 |
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort CGM Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%) | 59 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%) | 38 participants |
Comparison: 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.p-value: <0.001Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 15 participants |
| Primary Cohort CGM Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 8 participants |
| Primary Cohort CGM Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | >= 25 years | 17 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 7 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 9 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) | >= 25 years | 4 participants |
Comparison: 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.p-value: 0.01Regression, Logistic
p-value: 0.8Regression, Logistic
p-value: 0.005Regression, Logistic
Post Hoc
26-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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 14 participants |
| Primary Cohort CGM Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 7 participants |
| Primary Cohort CGM Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 15 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 6 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 7 participants |
| Primary Cohort Control Group | 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 3 participants |
Comparison: 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.p-value: 0.02Regression, Logistic
p-value: 0.67Regression, Logistic
p-value: 0.006Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort CGM Group | Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) | 21 participants |
| Primary Cohort Control Group | Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) | 3 participants |
Comparison: 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.p-value: <0.001Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Cohort CGM Group | Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) | 19 participants |
| Primary Cohort Control Group | Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) | 31 participants |
Comparison: 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.p-value: 0.002Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 24 participants |
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 30 participants |
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 20 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 5 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 18 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 19 participants |
Comparison: 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.p-value: 0.009Regression, Logistic
p-value: 0.57Regression, Logistic
p-value: <0.001Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 16 participants |
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 8 participants |
| Primary Cohort CGM Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 13 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 7 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 5 participants |
| Primary Cohort Control Group | Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 2 participants |
Comparison: 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.p-value: 0.04Regression, Logistic
p-value: 0.46Regression, Logistic
p-value: 0.003Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 12 participants |
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 7 participants |
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 0 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 7 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 7 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 5 participants |
Comparison: 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.p-value: 0.18Regression, Logistic
p-value: 0.84Regression, Logistic
p-value: 0.02Regression, Logistic
Other Pre-specified
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
Population: All analyses were performed according to the intention-to-treat principle.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 5 participants |
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 2 participants |
| Primary Cohort CGM Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 0 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 8-14 years | 2 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | 15-24 years | 2 participants |
| Primary Cohort Control Group | Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) | >=25 years | 1 participants |
Comparison: 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.p-value: 0.24Regression, Logistic
p-value: 0.98Regression, Logistic
p-value: 0.48Regression, Logistic