NCT00069602

Assessing Continuous Glucose Monitors in Healthy Children

DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring System (CGMS)
DEVICE	GlucoWatch G2TM Biographer (GW2B)

Timeline

• Start date: 2002-08-01
• Completion: 2002-11-01
• First posted: 2003-09-30
• Last updated: 2016-09-05

Locations

6 sites across 1 country: United States