Assessing Continuous Glucose Monitors in Healthy Children
Status and phase
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About
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.
Full 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.
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Inclusion and exclusion criteria
Inclusion Criteria
- Weight >= 16.0 kg (35 lbs)
- Body mass index between the 10th to 90th percentile for age and sex
- HbA1c within normal limits
- Hematocrit within normal limits
Exclusion Criteria
- History of diabetes
- History of positive islet cell antibody testing
- Family history of Type 1 or Type 2 diabetes in a sibling or parent
- Medication use of any type in the 7 days prior to study entry
- Skin abnormalities contraindicating device use
Trial design
Primary purpose
Allocation
Interventional model
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Trial contacts and locations
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Data sourced from clinicaltrials.gov
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