A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Singapore’s current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective at reducing the risks for complications of Type 2 Diabetes Mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health applications can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions. Objective: Using the RE-AIM evaluation framework, this study assesses the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care. Methods: This single-arm feasibility study recruited 100 patients with T2DM and glycosylated hemoglobin (HbA1c) levels of ≥7.5% from a single community healthcare facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco smartphone app with a health coaching feature. The GlycoLeap program was evaluated using four relevant dimensions of the RE-AIM framework: (1) Reach (percentage who consented to participate out of all patients approached), (2) Effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) Implementation (program engagement as assessed by various participatory metrics), and (4) Maintenance (post-intervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention). Results: A total of 785 patients were approached of which 104 consented to participate, placing the Reach at 13.2%. Four were excluded after eligibility screening and 100 patients were recruited. Program engagement (Implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (Implementation). Primary outcome data was available for 83 participants. Statistically significant improvements were observed for HbA1c (-1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (Effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (Effectiveness). User satisfaction was high with 59 (74%) and 63 (79%) out of 80 participants rating the app “good/very good” and claiming that they “would probably/definitely recommend” the app to others, respectively (Maintenance). Conclusions: Although measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved and with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost-effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months. Clinical Trial: The study is registered on ClinicalTrials.gov (www.clinicaltrials.gov) with the identifier NCT03091517.