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| Sponsor: | JDRF Artificial Pancreas Project |
|---|---|
| Information provided by: | JDRF Artificial Pancreas Project |
| ClinicalTrials.gov Identifier: | NCT00406133 |
Purpose
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will follow an identical protocol to that of the first cohort with HbA1c >=7.0%.
The >=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group.
After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Device: Continuous glucose monitor |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes |
| Enrollment: | 451 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard intensive glucose monitoring
Patients in the control group were given blood glucose meters and test strips and asked to perform home blood glucose monitoring at least four times daily.
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Active Comparator: Continuous Glucose Monitoring (CGM)
Patients in the CGM group were instructed to use the CGM device on a daily basis and to verify the accuracy of the glucose measurement with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).
|
Device: Continuous glucose monitor
Daily use of a continuous glucose monitor
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
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)
Subjects >9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish
Exclusion Criteria:
The presence of any of the following diseases:
Home use of RT-CGM in past 6 months
Contacts and Locations| United States, California | |
| University of Southern California | |
| Beverly Hills, California, United States, 90211 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92111 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Atlanta Diabetes Associates | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Iowa | |
| Children's Hospital of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Massachusetts | |
| Joslin Diabetes Center - Children | |
| Boston, Massachusetts, United States, 02215 | |
| Joslin Diabetes Center - Adults | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98105 | |
| Study Director: | Roy W Beck, MD, PhD | Jaeb Center for Health Research |
| Study Chair: | Lori Laffel, MD | Joslin Diabetes Center Pediatric Section |
| Study Chair: | William V. Tamborlane, MD | Yale University |
More Information
| Responsible Party: | Roy W. Beck, Jaeb Center for Health Research |
| ClinicalTrials.gov Identifier: | NCT00406133 History of Changes |
| Other Study ID Numbers: | 2006-2402 |
| Study First Received: | November 30, 2006 |
| Results First Received: | May 11, 2009 |
| Last Updated: | September 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |