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Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00069628
First received: September 29, 2003
Last updated: January 5, 2006
Last verified: January 2006

September 29, 2003
January 5, 2006
July 2003
Not Provided
HbA1c value obtained 6 months after randomization
Not Provided
Complete list of historical versions of study NCT00069628 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
DirecNet Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children

This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Insulin-Dependent
  • Device: GlucoWatch® G2™ Biographer (GW2B)
  • Device: Continuous Glucose Monitoring System (CGMS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2004
Not Provided

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
Both
7 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069628
DirecNet 004, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: William V Tamborlane, MD Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP