Effects of Continuous Glucose Monitoring on Glycemic Control, Mental Health and Self-Management in Adults with Type 1 Diabetes: A Randomized Controlled Trial

<b>Background/Objectives</b>: Adults with type 1 diabetes (T1D) often experience psychological distress that interferes with their ability to maintain optimal self-care. The purpose of this study was to evaluate the effectiveness of the <i>Diabself-care</i>, a nurse-led structured diabetes self-management education (DSME) intervention designed to improve glycemic control, self-care practices and mental health among adults with T1D. <b>Methods</b>: A total of 224 adults with type 1 diabetes were randomized and final analyses included 110 participants in the intervention group and 106 in the control group. The intervention group received the <i>Diabself-care</i> program, consisting of five daily 90 min sessions integrating education, skill training, self-management and coping strategies in addition to usual care. The control group received standard diabetes care. Outcomes were assessed at baseline, 1 month and 3 months. The primary measure was glycemic control and secondary outcomes including self-management, anxiety and depressive symptoms. <b>Results</b>: The intervention group achieved a significant increase in time in range at both 1 and 3 months. Self-management adherence improved significantly in the intervention group (<i>p</i> < 0.001). Anxiety and depression scores decreased significantly in the intervention group at 1 and 3 months, while they remained unchanged in controls. Regression analyses identified depressive symptoms as the strongest predictor of anxiety (OR = 4.34, 95% CI = 2.99-6.28, <i>p</i> < 0.001), while female sex, older age, and low self-management were predictors of depression. Belonging to the intervention group was strongly protective against depression (OR = 0.11, 95% CI = 0.05-0.24, <i>p</i> < 0.001). <b>Conclusions</b>: The <i>Diabself-care</i> program significantly improved glycemic control, self-management, and psychological outcomes in adults with T1D. These findings highlight the dual clinical and mental health benefits of structured nurse-led DSME, supporting its integration into routine diabetes care. The trial is registered at ClinicalTrials.gov, ID: NCT05159843.