Endocrine Abstracts

Background: People with Diabetes (PwD) experience many obstacles in diabetes management including, but not limited to lack of motivation, limited knowledge on diabetes self-management and treatment adherence issues. Diabetes mandates regular follow-ups for good glycemic control and manage complications. Internet and smartphones, have revolutionized digital health and hence by employing digital health and technology, better outcomes may be achieved; which is realizable in Indian context with a very high smartphone prevalence adding value to manage the burden of world’s second largest population with diabetes. IMPACT program by OneCare is a personalised digital comprehensive care program for PwD providing holistic management of diabetes. Very little scientifically robust data is available for the plethora of available commercial diabetes apps in the country. The objective of OneCare IMPACT trial is to determine the effectiveness of IMPACT program on glycemic variability, glycemic and metabolic parameters, including medicine changes over the standard of care.

Methods/Design: The IMPACT trial is an Indian open label, multi-centre, randomized, controlled study. 120 patients with an established diagnosis of T2DM, aged 18-70 years, having a smartphone access will be randomly assigned to standard care versus IMPACT program over standard care. Blinded CGMs would be applied before and at the end of interventions in both the groups. OneCare program interventions are virtual, coach-interactive sessions delivered over 12 weeks. The interventions will include qualified CDE as health coach, yoga, physical training and emotional wellness sessions, and mobile app to log-in the blood glucose, diet plan/ meal pictures, exercise/step counts, sleep hours. Patients in the control group will receive standard of care, driven by diabetes educators, meted out by the centre. IMPACT is powered to expect an effect size of 0·8 (SD 2·1) mmol/l between two groups. The primary outcome analysis would be CGM metric variations (glycemic variability, time in range and mean amplitude of glucose excursions). Secondary endpoints include changes in HbA1c, BMI, pulse rate and blood pressure. Change in medicine dosages, laboratory parameters (FPG, PPG, lipid profile, hsCRP) and hypoglycaemic events are further outcome parameters of interest.

Discussion: In light of paucity in studies looking at the efficacy of digital DSME programs in Indian population, the IMPACT trial would substantially contribute to the scientific evaluation of the efficacy of OneCare program in T2DM to provide evidence to encourage the usage. Clinical Trials Registry-India number: CTRI/2022/09/045748.