Klue uses an Apple watch to detect hand motions indicative of eating or drinking. We hypothesized that real-time meal reminders delivered by Klue could decrease missed meal boluses and hemoglobin A1c (HbA1c) in adolescents and young adults with diabetes and 4 missed meal boluses in the previous 2 weeks.
This was a randomized, crossover, unmasked clinical study. Participants using continuous glucose monitor (CGM) with an insulin pump were randomized to either Klue for the first 6 weeks or standard care. There were 3 definitions for a meal occurrence: (1) Klue detection, (2) CGM rate of change of 2mg/dL/min for 20 minutes after cubic spline smoothing and (3) boluses for carbohydrates. Boluses were classified as premeal if ≤30 minutes prior to a CGM event, late if after CGM event but within 2 hours, and missed if no bolus within 2 hours.
17 participants (mean age 17.7±4.6 years) were enrolled and 8 were randomized to start with Klue. The patients on Klue had a HbA1c decrease of 0.5% compared to the usual care arm (p=0.004). There were significantly fewer missed meal boluses (p < 0.00001) with Klue utilization. On average, Klue detected a missed meal bolus 18 minutes prior to a significant CGM rate of change and there was 1 Klue false-positive every 2-3 days.
Automated meal reminders improved HbA1c and reduced the number of late meal boluses. In addition to improving compliance, this technology has the potential to provide more rapid meal announcements to a closed-loop insulin delivery system.