Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer

Sponsor

Jaeb Center for Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT00069628

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

200

Enrollment

Locations

16.1

Duration (Months)

33.3

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2003

Study Completion Date :

Nov 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Division of Pediatric Endocrinology and Diabetes, Stanford University	Stanford	California	United States	94305-5208
2	Barbara Davis Center for Childhood Diabetes, University of Colorado	Denver	Colorado	United States	80262
3	Department of Pediatrics, Yale University School of Medicine	New Haven	Connecticut	United States	06519
4	Nemours Children's Clinic	Jacksonville,	Florida	United States	32207
5	Jaeb Center for Health Research	Tampa	Florida	United States	33647
6	Department of Pediatrics, University of Iowa Carver College of Medicine	Iowa City	Iowa	United States	52242