Structured Online Diabetes Self-Management Education and Support for Adults with Type 1 Diabetes and Suboptimal Glycemic Control: The OPTIM@TE Pilot Randomized Controlled Trial

Evidence directly comparing equivalent structured online and face-to-face diabetes self-management education and support (DSMES) programs is limited. This pilot randomized controlled trial evaluated the feasibility and preliminary effectiveness of delivering the same structured group-based DSMES program online versus face-to-face in adults with type 1 diabetes (T1D) and suboptimal glycemic control. OPTIM@TE was an open-label, parallel-group, pilot randomized controlled trial in adults with T1D, glycated hemoglobin (HbA1c) ≥ 7.5%, and access to a personal digital device randomized (1:1) to an online or an equivalent face-to-face structured DSMES program. Both interventions shared the same curriculum and planned educational duration (≥ 10 h). The primary outcome was HbA1c at 12 months. Secondary outcomes included continuous glucose monitoring (CGM) metrics, anthropometric and metabolic variables, patient-reported and implementation outcomes. Fifty-one participants were randomized (26 online, 25 face-to-face). At 12 months, no significant between-group difference was observed in HbA1c (adjusted difference −0.07%; 95% CI −0.71 to 0.57; p = 0.831). No significant differences were found in CGM metrics, metabolic variables, or patient-reported outcomes. The only significant secondary outcome was greater improvement in Mediterranean diet adherence in the online group (adjusted difference 2.48 points; 95% CI 0.71–4.24; p = 0.009). Program completion was 41.2% overall (60.0% face-to-face versus 23.1% online), although participants who completed the program reported high satisfaction. Online group-based DSMES showed no significant differences in clinical and patient-reported outcomes to an equivalent face-to-face program in this pilot trial. Online delivery may represent a potential option for providing structured diabetes education; however, strategies to improve participant engagement and program completion are needed. Larger pragmatic, randomized trials are warranted to confirm these preliminary findings. ClinicalTrials.gov identifier NCT05708820.