Continuous Glucose Monitors for Children With Diabetes Mellitus

Jaeb Center for Health Research

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Device: The GlucoWatch® G2™ Biographer (GW2B); Device: The Continuous Glucose Monitoring System (CGMS™)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00069537

HD041919-01

DirecNet 001

HD041906-01

HD041890

HD041908-01

HD041915

HD041918-01

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)