Feasibility of a semiautomated, individualized coaching intervention for glycemic management in adults with type 1 diabetes: a pilot randomized controlled trial

Background: In the Korean Type 1 Diabetes Home Care Pilot Project, patients with type 1 diabetes (T1D) receive at least two monthly remote educational consultations from a multidisciplinary team. This randomized trial evaluated the feasibility and acceptability of individualized, semi-automated coaching messages based on continuous glucose monitoring (CGM) data for glycemic and emotional management in patients with T1D as a potential alternative to current treatments. Methods: Participants who had already enrolled in the national home care program for T1D were randomized in a 1:2 ratio to the control or intervention groups. The control group continued their current treatment, while the intervention group received weekly CGM-based coaching messages for glycemic management and biweekly emotional support messages based on the Patient Health Questionnaire-9 (PHQ-9) for six weeks. Feasibility was assessed based on the difference in time in range (TIR; 70–180 mg/dL) at week 6, other CGM metrics, and patient-reported outcomes. Results: Eighteen participants were enrolled. At week 6, the median TIR was 72.6% (interquartile range [IQR], 46.8–77.0) in the control group (n = 6) and 79.0% (IQR, 65.0–82.1) in the intervention group (n = 12), with no significant difference (p = 0.33). The intervention group showed a significantly lower median PHQ-9 score (2.5) in week 6 compared to the control group (6.0) (p = 0.03). Conclusion: The use of individualized semi-automated coaching messages was feasible and acceptable for glycemic and emotional management in individuals with T1D. Further large-scale studies are needed to confirm these findings and assess their long-term clinical impact. Trial registration: ClinicalTrials.gov (NCT06525454).