Continuous Glucose Monitors for Children With Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
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* Device: The GlucoWatch® G2™ Biographer (GW2B)
* Device: The Continuous Glucose Monitoring System (CGMS™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry For children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender Weight >= 12 kg (26.5 lbs) if < 7 years of age and >= 16 kg (35 lbs) if >7 years of age Normal hematocrit Exclusion Criteria Current use of glucocorticoids Skin or other medical disorders that would affect completion of the study History of seizures other than those attributable to either hypoglycemia or high fever

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: The GlucoWatch® G2™ Biographer (GW2B)|nan|
|Device: The Continuous Glucose Monitoring System (CGMS™)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the GlucoWatch G2 Biographer and CGMS |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Insulin-Dependent, Type 1 Diabetes, Diabetes in Children, Continuous Glucose Monitoring Devices