OBJECTIVE: To evaluate usability, accuracy, and hypoglycemia detection of the GlucoWatch G2 Biographer (GW2B) in children aged 1 to 17 years. METHODS: After a 15-hour study of device accuracy, 46 children (15 <7 years, 31 > or =7 years) with type 1 diabetes were enrolled for an extended-wear outcome study: 2 daytime and 2 nighttime 15-hr wear periods each week and blood glucose monitoring 4 times daily for 3 months. RESULTS: A total of 531 paired GW2B/meter readings were available for accuracy assessment. The correlation coefficients were 0.58 and 0.74 (ages <7 and > or =7 years, respectively). There was no significant change in hemoglobin A1C)or weight-adjusted insulin dose at 3 months after biographer use. Forty-two episodes of hypoglycemia were detected by the GW2B, 33 of which were confirmed by blood glucose meters. Sensitivity and specificity of audible low-glucose alerts were approximately 79% and 83%, respectively. No significant side effects were reported. CONCLUSION: The GW2B is usable and safe in children who are <7 years or older in the home setting. The GW2B can detect asymptomatic nocturnal hypoglycemia in younger children.
OBJECTIVE: To evaluate usability, accuracy, and hypoglycemia detection of the GlucoWatch G2 Biographer (GW2B) in children aged 1 to 17 years. METHODS: After a 15-hour study of device accuracy, 46 children (15 <7 years, 31 > or =7 years) with type 1 diabetes were enrolled for an extended-wear outcome study: 2 daytime and 2 nighttime 15-hr wear periods each week and blood glucose monitoring 4 times daily for 3 months. RESULTS: A total of 531 paired GW2B/meter readings were available for accuracy assessment. The correlation coefficients were 0.58 and 0.74 (ages <7 and > or =7 years, respectively). There was no significant change in hemoglobin A1C)or weight-adjusted insulin dose at 3 months after biographer use. Forty-two episodes of hypoglycemia were detected by the GW2B, 33 of which were confirmed by blood glucose meters. Sensitivity and specificity of audible low-glucose alerts were approximately 79% and 83%, respectively. No significant side effects were reported. CONCLUSION: The GW2B is usable and safe in children who are <7 years or older in the home setting. The GW2B can detect asymptomatic nocturnal hypoglycemia in younger children.