Home use of the GlucoWatch G2 biographer in children with diabetes
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Published on: June 11, 2012
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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