Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
JDRF Artificial Pancreas Project |
---|---|
Information provided by: | JDRF Artificial Pancreas Project |
ClinicalTrials.gov Identifier: | NCT00406133 |
Subjects with intensively-treated type 1 diabetes and 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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes |
Enrollment: | 451 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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
HbA1c7.0%-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
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
Kaiser Permanente | |
San Diego, California, United States, 92111 | |
University of Southern California | |
Beverly Hills, California, United States, 90211 | |
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 |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck ) |
Study ID Numbers: | 2006-2402 |
Study First Received: | November 30, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00406133 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |