Continuous Glucose Monitors for Children With Diabetes Mellitus

Phase 4

Completed

• Conditions: Diabetes Mellitus, Insulin-Dependent

• Registration Number: NCT00069537
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

Good control of blood glucose levels is important in preventing complications from diabetes. This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B), 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. Intensive therapy has not been systematically evaluated in children less than 13 years of age. This study was conducted by the Diabetes Research in Children Network (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting.

During 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day and night. To assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.

Study Timeline

• Study Start: 2002-05
• Study Completion: 2002-11
• 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: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of the GlucoWatch G2 Biographer and CGMS

Trial Locations

Locations (6)

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

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

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