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 the mySugr® app.

Purpose: Mobile applications (apps) have proven to be highly effective tools to empower patients with type 1 diabetes mellitus (T1DM) and enable them to achieve better self-care, quality of life (QOL), and glycemic control. The aim of the study is to examine whether mySugr^®, an app for diabetes management, together with teleconsultations, can have a positive impact on these factors and, thereby, replace current clinical care.

Methods: This study concerns an exploratory randomized clinical trial of 12 months' duration. People with T1DM using multiple daily injections were randomized to usual care (bolus calculator, five face-to-face visits) or intervention (mySugr^® app, three face-to-face visits, and two teleconsultations). The main outcome was increase in empowerment assessed with the Diabetes Empowerment Scale Short Form questionnaire (DES-SF-S). Secondary outcomes were change in additional glucose-related (blood glucose monitoring, mean blood glucose, standard deviation, coefficient of variation (CV), and high and low blood glucose index) and patient-reported outcome measures (PROMs) (self-management, QOL, and distress).

Results: A total of 25 out of 28 participants completed the study (52% men, age 44.52 years, diabetes duration 21.28 years). At 12 months, no significant differences were identified in the change of DES-SF-S and additional PROMs between arms. Similarly, no differences were observed 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 to and satisfaction with the app were high.

Conclusion: Patients with diabetes using the mySugr^® app and teleconsultation achieved similar results to those following usual care in empowerment, other PROMs, and most glucose-related outcomes, thus supporting its use in combination with face-to-face visits. The RCT was registered with ClinicalTrials.gov (NCT03819335, first registration 28/01/2019).