Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Registration Number
- NCT00069628
- Lead Sponsor
- Jaeb Center for Health Research
- Brief Summary
This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM).
- Detailed Description
Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia, and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. The Diabetes Research in Children Network (DirecNet) was established to evaluate the feasibility and effectiveness of intensive glycemic control in children with T1DM.
This study is designed to evaluate glycemic control, hypoglycemia, and quality of life when using a GlucoWatch G2TM Biographer (GW2B) versus standard care. Children in the study will use the GW2B in their home environment in order to assess if the GW2B can help to safely lower blood sugar levels (as measured by the glycosylated hemoglobin test), to learn how using the GW2B affects the daily lives of children with diabetes, and to find out if there are any drawbacks to using the GlucoWatch.
As part of the study, participants in the intervention group will also use a second glucose monitoring device called the Continuous Glucose Monitoring System (CGMS). The CGMS will be inserted at baseline and at Months 3 and 6; it will be worn for three days after each visit. The CGMS will be used to measure changes in biochemical hypoglycemia.
Participants at five participating centers will include a total of 200 children and adolescents with type 1 diabetes. Of the 200 children, 100 will be randomized to wear the GW2B and 100 will be randomized to usual care without GW2B. Each patient will be provided with a personal computer for weekly downloading of data and completion of questionnaires regarding hypoglycemia. Phone contacts will be made with the patients after Weeks 1, 2, and 4, then every 4 weeks to review their diabetes management. At Months 3, 6, 9 and 12, a follow-up visit will be performed to measure HbA1c. The CGMS sensor will be inserted to assess hypoglycemia at baseline and Months 3 and 6. At the 6-month follow-up visit, psychosocial questionnaires will also be administered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method HbA1c value obtained 6 months after randomization
- Secondary Outcome Measures
Name Time Method Number of hypoglycemic events during 6 months Diabetes Worry Scale at 6 months PedsQL Diabetes Module at 6 months Diabetes Self Management Profile at 6 months
Trial Locations
- Locations (6)
Division of Pediatric Endocrinology and Diabetes, Stanford University
🇺🇸Stanford, California, United States
Department of Pediatrics, Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Nemours Children's Clinic
🇺🇸Jacksonville,, Florida, United States
Jaeb Center for Health Research
🇺🇸Tampa, Florida, United States
Department of Pediatrics, University of Iowa Carver College of Medicine
🇺🇸Iowa City, Iowa, United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
🇺🇸Denver, Colorado, United States