Background: We aim to evaluate the efficacy of personalized intervention based on a mobile phone application in patients with type 2 diabetes (T2DM).
Methods/Design: This is a 26-week randomized controlled, open-label, and parallel group trial. A total of 275 patients with T2DM having HbA1c ≥7.5% were recruited from two medical centers. Participants were randomized 1:1:1 and assigned to three groups: 1) usual care, 2) mobile diabetes management, or 3) mobile diabetes management with personalized feedback from health care professionals every two weeks. In groups 2 and 3, a mobile application integrated with the hospital electronic medical record (EMR) system is used to support diabetes management in addition to usual care. The primary outcome is change in HbA1c from baseline to 26 weeks; there are ten additional secondary outcomes, including insulin resistance, and lifestyle changes.
Results: Of the 275 initial participants, 20 (7.3%) dropped out. Mean participant age is 52.2±12.4 years, females comprise 56.4%, and the mean duration of diabetes is 11.5±8.6 years. Baseline characteristics including HbA1c are not significantly different between the groups. During the first 12 weeks, significant reduction in % change of HbA1c was observed in both mobile app-based intervention groups relative to the control group (group 1, -6.0±11.1% vs. group 2, -9.2±13.3% vs. group 3, -10.7±12.0%; P value=0.041). Participants in the intervention group measured their blood glucose more frequently, but occurrence of hypoglycemia was not different among the three groups. The majority (87.4%) of app-using participants were satisfied with the app, indicating that it was easy to use and made them adherent to their diabetes care.
Discussion: This trial is currently ongoing and will evaluate the clinical efficacy, features promoting clinical efficacy and patient engagement, and cost effectiveness of diabetes management using an EMR-integrated mobile application in patients with T2DM.
J. Yun: None. S. Lim: None. S. Cha: None. K. Yoon: None. Y. Ahn: None. E. Lee: None. S. Ko: None.
Korea Health Industry Development Institute (HI19C0784)