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The Accuracy of the GlucoWatch ® G2 ™ Biographer in Children with Type 1 Diabetes: Results of the Diabetes Research in Children Network (DirecNet) Accuracy Study

2003; Mary Ann Liebert, Inc.; Volume: 5; Issue: 5 Linguagem: Inglês

10.1089/152091503322526996

1557-8593

Pancreatic function and diabetes

Objective-To assess the accuracy of the GlucoWatch® G2 ™ Biographer (GW2B) in children and adolescents with type 1 diabetes mellitus (T1DM).Research Design and Methods-During a 24-hour clinical research center stay, 89 children and adolescents with T1DM (aged 3.5 to 17.7 years) wore 174 GW2Bs and had frequent serum glucose determinations during the day and night and during insulin-induced hypoglycemia and mealinduced hyperglycemia, resulting in 3,672 GW2B-reference glucose pairs.Results-The median relative absolute difference between the GW2B and reference glucose values was 16% (25 th , 75 th percentiles = 7%, 29%).The proposed ISO criteria were met for 60% of sensor values.Accuracy was better at higher serum glucose levels than low glucose levels.Accuracy degraded slightly as the sensor aged.Time of day, subject age, gender, or body mass index did not impact GW2B accuracy.There were no cases of serious skin reactions.Conclusion-Although the accuracy of this generation of sensor does not approach that of current home glucose meters, the majority of sensor glucose values are within 20% of the serum glucose.This level of accuracy may be sufficient for detecting trends and modifying diabetes management.Further longitudinal outpatient studies are needed to assess the utility of the GW2B as a management tool to improve glycemic control and decrease the incidence of severe hypoglycemia in children with diabetes.The Diabetes Research in Children Network (DirecNet) is a NIH-funded collaborative study group that consists of five clinical centers, a coordinating center, a central laboratory, and representatives from NICHD and NIDDK.The major objective of DirecNet is to critically evaluate the clinical usefulness of current and future glucose sensor devices in youth with T1DM.As a prelude to conducting clinical trials to evaluate use of glucose sensors as management tools for children and adolescents with diabetes, the DirecNet Accuracy Study was developed to independently assess the performance of the GlucoWatch Automatic Glucose Biographer ("GWB"; Cygnus Inc. Redwood City, CA) and the Continuous Glucose Monitoring System ("CGMS™"; Medtronic MiniMed, Northridge, CA) in children from 1 to <18 years of age.The purpose of this paper is to report our findings with respect to the accuracy of the second generation GlucoWatch Automatic Glucose Biographer, the GlucoWatch® G2 ™