Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer

This study has been completed.

Study NCT00069628. Last updated on January 5, 2006. Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer

Official Title ^†

DirecNet Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

HbA1c value obtained 6 months after randomization

Secondary Outcome Measure ^†

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

Condition ^†

Diabetes Mellitus, Insulin-Dependent

Intervention ^†

Device: GlucoWatch® G2™ Biographer (GW2B)
Device: Continuous Glucose Monitoring System (CGMS)

MEDLINE PMIDs

15738708, 15787896, 15855573, 15784705, 16043752, 16043734

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

200

Start Date ^†

July 2003

Completion Date

November 2004

Eligibility 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

Gender

Both

Ages

7 Years to 17 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00069628

Organization ID

DirecNet 004

Secondary IDs ^††

HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915

Study Sponsor ^†

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^††

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

Investigators ^†

Study Chair:

William V Tamborlane, MD

Yale University

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

January 2006

First Received Date ^†

September 29, 2003

Last Updated Date

January 5, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.