DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Jaeb Center for Health Research
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Accuracy of the GlucoWatch G2 Biographer and CGMS sensors
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Accuracy of the GlucoWatch G2 Biographer and CGMS sensors