Efficacy of Personalized Diabetes Self-Care Using an Electronic Medical Record-Integrated Mobile Application in Patients with Type 2 Diabetes: A Six-Month Randomized Controlled Trial (Preprint)

BACKGROUND A system that combines technology and online coaching can help treat chronic conditions like diabetes. However, the effectiveness of apps in mHealth interventions is inconclusive and unclear due to heterogeneous interventions and varying durations of follow-up. Additionally, randomized controlled trial data is limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records. OBJECTIVE We aimed to assess the effect of an electronic medical record-integrated mobile application for personalized diabetes self-care, focusing on self-monitoring of blood glucose (SMBG) and lifestyle modification, on glycemic control in patients with type 2 diabetes (T2DM). METHODS In the 26-week, 3-arm randomized, controlled, open-label, and parallel group trial, T2DM patients with an A1C level ≥7.5% were recruited. The mHealth intervention consisted of SMBG with automatic transfer of glucose, diet and physical activity (PA) counseling data (iCareD system). Participants were randomly assigned to three groups: 1) usual care (UC), 2) mobile diabetes self-care (MC), and 3) mobile diabetes self-care with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in A1C levels at 26 weeks. Additionally, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were measured after intervention. RESULTS A total of 269 participants were enrolled, and 234 patients (85.1%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean A1C decline was significantly different among the three groups (UC vs. MC vs. MPC, -0.49% vs. -0.86% vs. -1.04%, P=.016). The A1C level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, A1C level showed a statistically significant decrease after the intervention in the MPC group compared to the change in the UC or MC group, especially in the patients with age <65 years (P=.019), diabetes duration 10 years (P=.024), BMI 25.0 kg/m2 (P=.004), C-peptide 0.6 ng/mL (P=.008), and no treatment with insulin (P=.004) at 12 weeks. The target achievement rates of PA and daily calorie consumption at 26 weeks were higher in the MPC group than in the other two groups (all P CONCLUSIONS The mHealth intervention for diabetes self-care showed short-term efficacy on glycemic control, and the effect decreased over time. Participants were comfortable with the use of the iCareD system and exhibited high adherence. CLINICALTRIAL Clinical Research Information Service (CRIS), Republic of Korea (No. KCT0004128). Date of registration July 05, 2019