Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India

Abstract

Background: In 2015, India had an estimated 69.2 million people with diabetes and a national prevalence of 8.7%. Evidence is mounting for the benefits of telemedicine in diabetes care, but remains limited on mobile-health (m-Health) interventions.

Introduction: This study assessed the impact of an m-Health diabetes platform on clinical outcomes, patient-reported outcomes, patient and provider satisfaction, and app usage.

Materials and methods: This open-label, two-arm parallel study enrolled 91 people at 3 sites in India, aged 18-65, with type 2 diabetes, and an A1c between 7.5% and 12.5% (58-113 mmol/mol). Participants were randomly assigned 1:1 to m-Health or usual care and observed for 6 months. All received free visits, laboratory tests, transportation fees, and strips and lancets. Intervention participants received the m-Health app and a mobile phone data stipend.

Results: A1c change was previously reported as statistically significant. Significantly more participants in intervention than control had improved medication adherence (39.0% vs. 12.8%; p = 0.03) and increased frequency of blood glucose (BG) self-testing (39.0% vs. 10.3%; p = 0.01) at 6 months from baseline. No other outcomes were significantly different. Among m-Health users, 75% of participants actively used the app at week 24. Participants entered 29,668 medications and 2,575 BG readings, sent 497 messages, and received 890 messages. Most participants (80%) were satisfied with all aspects of the app and all seven providers rated the software very acceptable.

Discussion: Participants assigned to m-Health had increased medication adherence and frequency of BG testing compared with usual care participants.

Conclusions: This tool could be an effective way to expand access to quality chronic disease care and improve outcomes.

Trial registration: ClinicalTrials.gov NCT02587286.

Keywords: A1c; digital technology; e-Health; glucose control; m-Health; randomized clinical trial; technology; telemedicine.