Can a Mobile Application Improve Glucose-Related and Patient-Reported Outcome Measures (PROMS) in People with Type 1 Diabetes Mellitus? a Randomized Controlled Trial Using mySugr®APP

Abstract

Abstract Purpose: Mobile applications (app) emerge as effective tools to empower people with type 1 diabetes mellitus (T1DM) and provide better self-care, quality of life (QOL) and glycemic control. The aim of the study is to test if mySugr®, an app for diabetes management, together with teleconsultations, can have a positive impact on these aspects and replace current clinical care. Methods: Exploratory randomized clinical trial of 12 months of duration. People with T1DM were randomized to usual care (bolus calculator, 5 face-to-face visits) or intervention (mySugr® app, 3 face-to-face visits, 2 teleconsultations). Main outcome: Increase in empowerment, assessed with Diabetes Empowerment Scale Short Form questionnaire (DES-SF-S). Secondary outcomes: Change in additional glucose-related (blood glucose monitoring, mean blood glucose, standard deviation, coefficient of variation (CV), high and low blood glucose index) and patient-reported outcome measures (PROMs) (self-management, QOL and distress). Results: 25 out of 28 participants completed the study (52% men, age44.52 years, diabetes duration 21.28 years). At 12 months, no significant differences were detected in the change of DES-SF-S and additional PROMs between arms. Similarly, no differences were detected in glucose-related outcomes except for the change in CV at 9 (control -1.87±4.98 vs intervention 5.89±11.33, p=0.008) and 12 months (control -2.33±3.54 vs intervention 5.12±11.32, p=0.018). Adherence and satisfaction with the app were high. Conclusion: Patients with diabetes using mySugr® app and teleconsultation achieved similar results than those following usual care in empowerment, other PROMs and most glucose-related outcomes, supporting its use as an alternative. The RCT was registered with ClinicalTrials.gov (NCT03819335, first registration 28/01/2019).