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Home > "C" Clinical Trials Conditions > Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus  Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus
Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus
For Condition: Diabetes Mellitus, Insulin-Dependent
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Synopsis: This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 7 Years/17 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Clinical diagnosis of type 1 diabetes - Insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry - HbA1c between 7.0 and 11.0% - Stable insulin regimen for the 2 months prior to study entry and 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) - Agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor - Comprehend written English - Female participants must not intend to become pregnant during the next 6 months - Plan to remain in the area of the clinical center during the next 6 months
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
WilliamTamborlane, Study Chair, Yale University
Jaeb Center for Health Research
Tampa, Florida, 33647
United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, 80262
United States
Nemours Children’s Clinic
Jacksonville, Florida, 32207
United States
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, 94305-5208
United States
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519
United States
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
United States
Additional Information:
Study ID Numbers: HD041890-04; HD041908-01,HD041919-01,HD041918-01,HD041906-01,HD041915
Study Start Date: July 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069628
Other Diabetes Mellitus, Insulin-Dependent Studies:
1. Continuous Glucose Monitors for Children With Diabetes Mellitus
2. Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
3. Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus
4. Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Pediatric Population
5. Depression In Juvenile Diabetics
Related Studies:
Other Diabetes Mellitus, Insulin-Dependent Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus
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