| Resum: |
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). |
visitant ::
identificació
(Institut de Recerca Sant Pau)
