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Published on: June 11, 2012
Home use of the GlucoWatch G2 biographer in children with diabetes
Eba Hathout1, Nina Patel, Christina Southern
1Pediatric Diabetes Center, Loma Linda University, 11175 Campus St, CP A1120R, Loma Linda, CA 92354, USA. ehathout@ahs.llumc.edu.
Insights
The GlucoWatch G2 Biographer (GW2B) is safe and usable for children with type 1 diabetes. This device effectively detects nocturnal hypoglycemia in younger children.
Area of Science:
- Pediatric Endocrinology
- Medical Device Technology
- Diabetes Management
Background:
- Continuous glucose monitoring is crucial for managing type 1 diabetes in children.
- The GlucoWatch G2 Biographer (GW2B) is a wearable device designed for glucose monitoring.
- Evaluating its performance in pediatric populations is essential.
Purpose of the Study:
- To assess the usability, accuracy, and hypoglycemia detection capabilities of the GW2B in children aged 1 to 17 years.
- To determine the safety and efficacy of the GW2B for extended wear in a home setting.
- To specifically evaluate its ability to detect asymptomatic nocturnal hypoglycemia.
Main Methods:
- A 3-month extended-wear study involving 46 children (aged 1-17) with type 1 diabetes.
- Children underwent multiple 15-hour wear periods (day and night) weekly.
- Paired GW2B and blood glucose meter readings were collected for accuracy assessment, alongside HbA1c and insulin dose monitoring.
Main Results:
- Accuracy assessment showed correlation coefficients of 0.58 (<7 years) and 0.74 (≥7 years).
- The GW2B detected 42 hypoglycemia episodes, with 33 confirmed by meter; sensitivity was ~79%, specificity ~83%.
- No significant changes in HbA1c or insulin dose were observed; no significant side effects were reported.
Conclusions:
- The GW2B demonstrates usability and safety in children of all tested ages in a home environment.
- The device is capable of detecting asymptomatic nocturnal hypoglycemia, particularly in younger children.
- The GW2B offers a potentially valuable tool for diabetes management in pediatric patients.
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.
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