Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children

Phase 4

Completed

• Conditions: Diabetes Mellitus, Insulin-Dependent

• Registration Number: NCT00069615
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar levels, may improve the treatment of Type 1 diabetes mellitus in children. This study evaluated the GW2B when used by children in their homes.

Detailed Description

The proper role of the GW2B in the management of Type 1 diabetes in children has not been determined. As a prelude to a large-scale randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a GW2B versus standard care, the DirecNet Study Group conducted a pilot study to assess the feasibility of the protocol planned for the RCT and to collect data on changes in HbA1c, frequency of hypoglycemia, frequency of skin reactions, and quality of life after using the GW2B for three months.

Fifteen children and adolescents with Type 1 diabetes participated in this study. Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use. Participants received study telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes management. Participants had a follow-up visit at Week 29. The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days. A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires.

Study Timeline

• Study Start: 2003-02
• Study Completion: 2003-06
• Study First Submitted: 2003-09-29
• Study First Submitted QC: 2003-09-29
• Study First Posted: 2003-09-30
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of using the GlucoWatch G2 Biographer
Feasibility of collecting data from home computers

Trial Locations

Locations (6)

Department of Pediatrics, Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Division of Pediatric Endocrinology and Diabetes, Stanford University; 🇺🇸 Stanford, California, United States

Barbara Davis Center for Childhood Diabetes, University of Colorado; 🇺🇸 Denver, Colorado, United States

Department of Pediatrics, University of Iowa Carver College of Medicine; 🇺🇸 Iowa City, Iowa, United States

Nemours Children's Clinic; 🇺🇸 Jacksonville,, Florida, United States

Jaeb Center for Health Research; 🇺🇸 Tampa, Florida, United States