Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Oct 20, 2019
Date Accepted: Jun 13, 2020
Date Submitted to PubMed: Jun 16, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
One Drop and an Activity Tracker Improve A1c Among People with Type 1 Diabetes
ABSTRACT
Background:
In 2017, 9% of the population of adults with diabetes could receive digital care. By 2045, digital care will increase by 48%. One Drop’s (OD) digital care solution includes an evidence-based mobile app, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Using OD is associated with a 3-mo. -22.2 mg/dL (-.80% eA1c) among people with type 1 diabetes (T1D) and eA1c ≥ 7.5%. The added value of integrated activity trackers is unknown.
Objective:
We conducted a pragmatic randomized control trial to evaluate One Drop with an activity tracker on the A1c of adults with T1D.
Methods:
Social media advertisements and online newsletters recruited adults (≥ 18 years old) diagnosed (≥1 year) with T1D, naïve to OD’s full solution and the activity tracker with lab A1c ≥ 7%. Participants (N = 99) were randomized to get OD plus activity tracker at study start or OD at start and an activity tracker after 3 mos. Multiple imputation, performed separately by group, corrected for missing data. ANCOVA models, controlling for baseline A1c, tested 3-mo. A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses.
Results:
The enrolled sample (n = 95) was 41 ± 11 years old, 73% female, 88% White, diagnosed for 20 ± 11 years with a mean A1c of 8.4% ± 1.2%. 11% did not complete follow-up. The homogeneity of regression assumption was not met in ITT and PP models, requiring retention of the interaction term and examining effects at different levels of baseline A1c. In ITT and PP (with most OD engaged and complete data [n=77]), OD + tracker had a lower 3-mo than OD alone when baseline A1c was > 7% to ≤ 10% (ITT A1c MeanDiff .35% to .51%, p = .01 to .05 and PP A1c MeanDiff .27% to .47%, p = .02 to .05).
Conclusions:
Among people with T1D new to OD and tracker, using both was most beneficial when A1c were elevated, but not > 10%. OD and tracker may work better together than alone in helping people with T1D. Clinical Trial: NCT03459573
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