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.

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.