Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jul 2, 2020
Date Accepted: Sep 14, 2020
Effect of a Carbohydrate Counting Application for Youth with Type 1 Diabetes: A Pilot Randomized Control Trial
ABSTRACT
Background:
Carbohydrate counting is important, but also challenging, often performed inaccurately, and a barrier to diabetes management. iSpy is a novel mobile application designed to assist youth with type 1 diabetes (T1D) count carbohydrates.
Objective:
Our objective was to test its usability and potential impact on accuracy of carbohydrate counting.
Methods:
Three iterative cycles of usability testing were conducted involving a total of 16 individuals with T1D aged 8.5-17.0 years. Participants were provided iSpy on a mobile device and asked to complete tasks using application features while thinking aloud. Errors were noted and acceptability assessed with refinement and retesting across cycles. Next, iSpy was evaluated in a pilot randomized controlled trial (RCT) with 22 iSpy users and 22 usual care controls aged 10-17.0 years. Primary outcome was change in carbohydrate counting ability over 3 months. Secondary outcomes included levels of engagement and acceptability.
Results:
Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, p=0.008) and reduced frequency of individual errors ≥ 10 grams (p=0.047). Qualitative interviews and acceptability scale scores were positive. No major technical challenges were identified. Moreover, 43% of iSpy participants were still engaged, with usage at least once/two weeks, at the end of the study.
Conclusions:
Our results provide evidence of efficacy and high acceptability of a novel carbohydrate counting application, supporting the advancement of digital health applications for diabetes care among youth with T1D. Further testing is needed, but iSpy may be a useful adjunct to traditional diabetes management. Clinical Trial: ClinicalTrials.gov NCT04354142
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