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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Device: GlucoWatch® G2™ Biographer (GW2B)
Device: Continuous Glucose Monitoring System (CGMS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DirecNet Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • HbA1c value obtained 6 months after randomization

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: July 2003
Estimated Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069628

Locations
United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Nemours Children’s Clinic
Jacksonville, Florida, United States, 32207
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Iowa
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Study Chair: William V Tamborlane, MD Yale University
  More Information

Publications:
William Tamborlane, Dongyuan Xing, Michael Steffes, Craig Kollman, Katrina Ruedy, Roy Beck, Rosanna Fiallo-Scharer, Larry Fox, Darrell Wilson, Eva Tsalikian, and the Diabetes Research In Children Network (DirecNet) Study Group: Performance of the DCA2000 for Measurement of Hemoglobin A1c Levels in Children with T1DM in a DirecNet Outpatient Clinical Trial. Pediatr Res 2004; 55 (4 Pt 2):138A.
Michael Tansey, Roy Beck, Bruce Buckingham, Nelly Mauras, Rosanna Fiallo-Scharer, Dongyuan Xing, Craig Kollman, William Tamborlane, Katrina Ruedy, and the Diabetes Research in Children Network (DirecNet) Study Group: A Comparison of the Original vs. Modified Continuous Glucose Monitoring System (CGMS) Sensor During Using Data from Two DirecNet Studies. Diabetes 2004; 53(Suppl 2):A465.
Rosanna Fiallo-Scharer, Dongyuan Xing, Stuart Weinzimer, Bruce Buckingham, Nelly Mauras, Michael Tansey, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Utility of CGMS as a Measure of Glycemic Control in Children with Type 1 Diabetes (T1DM). Diabetes 2004; 53(Suppl 2):A67.
Peter Chase, Dongyuan Xing, Stuart Weinzimer, Bruce Buckingham, Nelly Mauras, Michael Tansey, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Comparison of 8-point Glucose Testing with Glycemic Control in Children with Type 1 Diabetes (T1DM). Diabetes 2004; 53(Suppl 2):A600.
Tim Wysocki, Dongyuan Xing, Rosanna Fiallo-Scharer, Elizabeth Doyle, Jennifer Block, Eva Tsalikian, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Self-Management Profile-Revised for Conventional and Flexible Insulin Regimens. Diabetes 2004; 53(Suppl 2):A436.
H. Peter Chase, Roy Beck, William Tamborlane, Bruce Buckingham, Nelly Mauras, Eva Tsalikian, Tim Wysocki, Stuart Weinzimer, Katrina Ruedy, Dongyuan Xing, and the Diabetes Research in Children Network (DirecNet) Study Group: Lack of Effectiveness of the GlucoWatch G2 Biographer in Altering Glycemic Control in Children with Type 1 Diabetes. Diabetes Technol Ther 2005; 7(2):370.
Darrell Wilson, Rosanna Fiallo-Scharer, Dongyuan Xing, Tim Wyscoki, Jennifer Block, Stu Weinzimer, Craig Kollman, Roy Beck, Katrina Ruedy, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Reliability of Two Indices of the Biologic Variability in Glycosylation among Children and Adolescents with T1DM. Diabetes 2005; 54(Suppl 1):A454.

ClinicalTrials.gov Identifier: NCT00069628     History of Changes
Other Study ID Numbers: DirecNet 004, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
Study First Received: September 29, 2003
Last Updated: January 5, 2006
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Diabetes in Children
Continuous Glucose Monitoring Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014