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).