Pragmatic Study Design to Assess the Effect of a mHealth Application on Empowerment of Noninsulin Treated Type 2 Diabetes People in a Low- and Middle-income Setup

Background: In low- and middle-income countries (LMICs), such as India, self-monitoring of blood glucose (SMBG) for people living with type 2 diabetes mellitus (T2DM) faces many barriers. mHealth applications that combine blood glucose (BG) assessment and the provision of actionable information can help overcome current challenges. Pragmatic study protocols assessing the medical value of mobile SMBG applications to deal with LMIC-specific challenges are missing. Aims and Objectives: This study will assess the impact of a mHealth application on diabetes empowerment using the Diabetes Empowerment Scale-Short Form questionnaire in noninsulin-treated people with T2DM in India. Methods: An observational, single-arm, prospective study will be conducted among adults ( n = 100) with T2DM who have not been using a BG meter before and were on diet, exercise, or noninsulin antidiabetic therapy. After enrollment (baseline) and an 8-week control phase, the people participating in the study will receive the mobile phone-based BG assessment devices and will receive a training for the application. During the observational period of 12 weeks (20 weeks after baseline), the subjects will monitor their BG ranges with the devices and the mobile application. At baseline and weeks 8, 14, and 20, diabetes empowerment will be assessed as primary outcome. Health literacy, diabetes treatment satisfaction, and user experience, among others, will be examined as secondary outcomes. Discussion: Mobile applications have the potential to improve diabetes care due to their higher reach, but pragmatic study designs are needed to evaluate the effectiveness. Conclusions: The results of this pragmatic study will provide more patient-reported insights on the impact of mobile applications on diabetes self-management in LMIC.