Type 1 Diabetes Clinical Trial
Official title:
A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes
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.
Status | Completed |
Enrollment | 451 |
Est. completion date | February 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Diabetes Associates | Atlanta | Georgia |
United States | University of Colorado | Aurora | Colorado |
United States | University of Southern California | Beverly Hills | California |
United States | Joslin Diabetes Center - Adults | Boston | Massachusetts |
United States | Joslin Diabetes Center - Children | Boston | Massachusetts |
United States | Children's Hospital of Iowa | Iowa City | Iowa |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Kaiser Permanente | San Diego | California |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
JDRF Artificial Pancreas Project |
United States,
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. — View Citation
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, L — View Citation
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, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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 | Baseline and 26 weeks | Yes |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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) | Baseline and 26 weeks | Yes |
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) | Baseline and 26 weeks | Yes |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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. | Baseline and 26 weeks | No |
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) | Baseline and 26 weeks | Yes |
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. | Baseline and 26 weeks | No |
Secondary | Quality of Life | 26 weeks | No | |
Secondary | Cost-effectiveness of CGM | 26 weeks | No |
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