Nora J Kleinman1,2, Avani Shah3, Sanjiv Shah3, Sanjeev Phatak4, Vijay Viswanathan5. 1. 1 Gather Health LLC , Hong Kong . 2. 2 NJK Consulting , Seattle, WA. 3. 3 Diabetes Action Centre , Mumbai, India . 4. 4 DHL Research Centre , Ahmedabad, India . 5. 5 Prof. M. Viswanathan Diabetes Research Centre , Chennai, 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.
RCT Entities:
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.
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