Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study

OBJECTIVE To investigate the effects of patient-driven lifestyle modification using intermittently scanned continuous glucose monitoring (isCGM) in patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS We conducted a 12-week, open-label, randomized controlled trial. A total of 126 participants were 1:1 randomized to either the intervention group (structured education + isCGM) or the control group (standard care with blood glucose monitor-ing). The Self-Evaluation Of Unhealthy foods by Looking at postprandial glucose (SEOUL) algorithm was developed and applied to aid structured education in guid-ing patients to follow healthy eating behavior depending on the postprandial glycemic response. The primary end point was the change in HbA_1c level from baseline. RESULTS Implementation of the SEOUL algorithm with isCGM was associated with greater improvement in HbA_1c than with standard care (risk-adjusted difference-0.50%, 95% CI-0.74 to-0.26, P < 0.001). Participants in the intervention group had a greater reduction in fasting blood glucose and body weight (-16.5 mg/dL, 95% CI-30.0 to-3.0, P = 0.017;-1.5 kg, 95% CI-2.7 to-0.3, P = 0.013, respectively). The score sum for the Korean version of the revised Summary of Diabetes Self-Care Activities Questionnaire increased in both groups but to a greater extent in the intervention group (mean difference 4.8, 95% CI 1.7–8.0, P = 0.003). No se-vere hyperglycemia or hypoglycemia was reported in either group of patients. CONCLUSIONS Patient-driven lifestyle modification primarily focused on eating behavior using isCGM effectively lowered HbA_1c levels in patients with T2D.