Automated Personalized Self-care Program for Patients With Type 2 Diabetes Mellitus: A Pilot Trial.

Purpose: Providing continuous self-care support to the growing diabetes population is challenging. Strategies are needed to enhance engagement in self-care, utilizing innovative technologies for personalized feedback. This study aimed to assess the feasibility of the Automated Personalized Self-Care program among type 2 diabetes patients and evaluate its preliminary effectiveness.

Methods: A parallel randomized pilot trial with qualitative interviews occurred from May 3, 2022, to September 27, 2022. Participants aged 40-69 years with type 2 diabetes and HbA1c ≥ 7.0% were recruited. The three-month program involved automated personalized goal setting, education, monitoring, and feedback. Feasibility was measured by participants' engagement and intervention usability. Preliminary effectiveness was examined through self-care self-efficacy, self-care behaviors, and health outcomes. Qualitative interviews were conducted with the intervention group.

Results: A total of 404 patients were screened. Out of the 61 eligible patients, 32 were enrolled, resulting in a recruitment rate of 52.5%. Retention rates at three months were 84.2% and 84.6% in the intervention and control groups, respectively. Among the intervention group, 81.3% satisfied adherence criteria. Mobile application's usability scored 66.25, and participants' satisfaction was 8.06. Intention-to-treat analysis showed improvements in self-measured blood glucose testing, grain intake, and HbA1c in the intervention group. Qualitative content analysis identified nine themes.

Conclusion: Feasibility of the program was verified. A larger randomized controlled trial is needed to determine its effectiveness in self-care self-efficacy, self-care behaviors, and health outcomes among type 2 diabetes patients. This study offers insights for optimizing future trials assessing clinical effectiveness.

Trial Registration: Clinical Research Information Service, KCT0008202 (registration date: 17 February 2023).