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| Name | Class |
|---|---|
| JDRF Artificial Pancreas Project | NETWORK |
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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.
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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intensive glucose monitoring | No Intervention | 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. | |
| Continuous Glucose Monitoring (CGM) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor | Device | Daily use of a continuous glucose monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 26 weeks |
| Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) |
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
Age >8 years
Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and <7.0% for the secondary cohort
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)
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
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:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Roy W Beck, MD, PhD | Jaeb Center for Health Research | Study Director |
| Lori Laffel, MD | Joslin Diabetes Center Pediatric Section | Study Chair |
| William V. Tamborlane, MD | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Beverly Hills | California | 90211 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18828243 | Background | 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. | |
| 18779236 | Result | 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. |
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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 were recruited from within the patient population of the study clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Cohort RT-CGM Group | Participants with baseline A1c >=7.0% who were randomized to CGM use |
| FG001 | Primary Cohort Control Group | Participants with baseline A1c >=7.0% who were randomized to standard care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 (First 26 Week Period) |
|
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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. |
| 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. | 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. | 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) | 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) | 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. | 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. | 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. | 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. | 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. | 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) | 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. | 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. | 26 weeks |
| Cost-effectiveness of CGM. | Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group | 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. | 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). | 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 26 weeks |
| 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 |
| 19429875 | Result | 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. |
| 21505208 | Derived | 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. |
| 21299401 | Derived | 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. |
| 21266651 | Derived | 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. |
| 21266647 | Derived | 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. |
| 20200306 | Derived | 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. |
| 19837791 | Derived | 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. |
| 19675206 | Derived | 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. |
| 19675193 | Derived | 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. |
| FG002 | Secondary Cohort RT-CGM Group | Participants with baseline A1c <7.0% who were randomized to CGM use |
| FG003 | Secondary Cohort Control Group | Participants with baseline A1c <7.0% who were randomized to standard care |
| COMPLETED |
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| NOT COMPLETED |
|
| Phase 2 (Second 26 Week Period) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Cohort RT-CGM Group | Participants with baseline A1c >=7.0% who were randomized to CGM use |
| BG001 | Primary Cohort Control Group | Participants with baseline A1c >=7.0% who were randomized to standard care |
| BG002 | Secondary Cohort RT-CGM Group | Participants with baseline A1c <7.0% who were randomized to CGM use |
| BG003 | Secondary Cohort Control Group | Participants with baseline A1c <7.0% who were randomized to standard care |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| College graduate (subject or primary care giver) | Number | participants |
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| Insulin modality | Number | participants |
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| One or more severe hypoglycemic events in last six months | Number | participants |
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| Duration of diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Glycated hemoglobin (HbA1c) | Mean | Standard Deviation | percent |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | Percent | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | May 2009 | Median | Inter-Quartile Range | minutes/day | Baseline and 26 weeks |
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| 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 | All analyses were performed according to the intention-to-treat principle. | Posted | Number | subjects with event | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | minutes/day | Baseline and 26 weeks |
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| 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) | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | minutes/day | Baseline and 26 weeks |
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| 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) | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Mean | Standard Deviation | Mean mg/dl/minute | Baseline and 26 weeks |
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| 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. | 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). | Posted | Dec 2009 | Mean | Standard Deviation | Percent | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Median | Inter-Quartile Range | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Median | Inter-Quartile Range | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Median | Inter-Quartile Range | minutes/day | Baseline and 26 weeks |
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| 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) | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Median | Inter-Quartile Range | minutes/day | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Median | Inter-Quartile Range | mg/dl/min | Baseline and 26 weeks |
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| 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. | Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
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| Secondary | Cost-effectiveness of CGM. | Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group | Baseline A1c<7%. | Posted | Number | dollars per QALY | 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Number | participants | Baseline and 26 weeks |
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| 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. | All analyses were performed according to the intention-to-treat principle. | Posted | Dec 2009 | Number | participants | Baseline and 26 weeks |
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| 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. | Baseline A1c <7.0% | Posted | Mean | Standard Error | weeks | 26 weeks |
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| 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). | Baseline A1c < 7.0% | Posted | Mean | Standard Error | dollars | 26 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Cohort RT-CGM Group | Participants with baseline A1c >=7.0% who were randomized to CGM use | 7 | 165 | 4 | 165 | ||
| EG001 | Primary Cohort Control Group | Participants with baseline A1c >=7.0% who were randomized to standard care | 12 | 157 | 3 | 157 | ||
| EG002 | Secondary Cohort RT-CGM Group | Participants with baseline A1c <7.0% who were randomized to CGM use | 7 | 67 | 0 | 67 | ||
| EG003 | Secondary Cohort Control Group | Participants with baseline A1c <7.0% who were randomized to standard care | 7 | 62 | 0 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Defined as an event that required assistance from another person to administer oral carbohydrate, glucagon, or other resuscitative actions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
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| Cellulitis related to sensor use | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Dizziness during blood draw | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Anxiety and depression | Psychiatric disorders | Non-systematic Assessment |
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| Kidney laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Seizure not caused by hypoglycemia | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy W. Beck, M.D., Ph.D., Director | Jaeb Center for Health Research | 813-975-8690 | rbeck@jaeb.org |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| 15-24 years |
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| >=25 years |
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| Male |
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| Other |
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| Other |
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| Multiple daily injections |
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| No events |
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| 15-24 years |
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| >=25 years |
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| >=25 years |
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| Superiority or Other |
| ANCOVA | Performed in each age group and adjusted for the baseline A1c and clinical center. | 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. | Superiority or Other |
| ANCOVA | Performed in each age group and adjusted for the baseline A1c and clinical center. | <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. | Superiority or Other |
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