NCT03970889

Real-time Reminders To Decrease Late or Missed Meal Boluses

Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.

Detailed description

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Klue	Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.

Timeline

• Start date: 2018-10-12
• Primary completion: 2020-03-19
• Completion: 2020-03-30
• First posted: 2019-06-03
• Last updated: 2021-09-02

Locations

1 site across 1 country: United States