Assessing Continuous Glucose Monitors in Healthy Children

Phase 4

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00069602
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

Detailed Description

The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Study Timeline

• Study Start: 2002-08
• 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: 20

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 sensors

Trial Locations

Locations (6)

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

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

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

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

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

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