Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes

Background: Our objective was to assess the effect of a hybrid telemedicine approach, in conjunction with face-to-face follow-up, on the quality of life in recent users of an advanced hybrid closed-loop (AHCL) system. Methods: A 1-year open randomized (1:1) clinical trial (ClinicalTrials.gov ID NCT04900636). Participants with type 1 diabetes (T1D) recent users of an AHCL system (Minimed (R) 780G) for at least 2-6 months, and >= 18 years old were eligible. The primary outcome was the change in quality of life measured by the Type 1 Diabetes Life (ViDa1) Questionnaire from baseline to 12 months of hybrid telemedicine plus face-to-face follow-up compared to standard clinical practice. Additionally, impacts on A(1c) levels, glucose metrics, advert events, and safety outcomes were assessed. Results: Between January and December 2021, 46 participants were randomly assigned in a 1:1 ratio to either the hybrid telemedicine group (n = 23) or the control group (n = 23); 45 participants completed the study, with only 1 from the control group withdrawing before visit 3. At baseline, mean age was 37 +/- 15 years and A(1c) was 6.9 +/- 0.5%. After 12 months, no statistically significant differences in ViDa1 scores between groups were observed. Despite reducing in-person visits in the hybrid follow-up arm, there were no increases in adverse events. Overall, A(1c) levels significantly decreased from 6.9 +/- 0.5% at baseline to 6.7 +/- 0.5% after 12 months (P = 0.006) without differences between treatment arms, accompanied by reductions in glycemic variability and time below the target range. Conclusion: Our study suggests that there were no significant differences in ViDa1 scores between the two groups at the end of the follow-up. However, among adult patients with T1D who recently adopted an AHCL system, satisfactory glycemic control can be attained through a hybrid follow-up approach, reducing face-to-face visits, without increasing technical complications.