Metabolic and vascular outcomes after transition to the MiniMed 780G system in adults ≥65 years with type 1 diabetes: a randomised, single-centre study.

AIMS/HYPOTHESIS: Hybrid closed-loop insulin delivery systems are increasingly regarded as the preferred therapy for type 1 diabetes, although evidence in older adults remains limited. The aim of this randomised study was to evaluate the effectiveness and safety of the MiniMed 780G system in individuals with type 1 diabetes aged ≥65 years, with HbA1c<86 mmol/mol (10%), who were naive to this technology, with the primary endpoint based on glycaemic management (time in range). Vascular status and other glycaemic metrics were assessed as secondary outcomes.

METHODS

This single-centre, open labelled (outcome assessors were not masked), randomised, controlled, parallel-group trial enrolled 34 participants who were randomly assigned in a 1:1 ratio using a computer-generated randomisation schedule to either advanced hybrid closed-loop (AHCL) therapy or control therapy (multiple daily injections or continuous subcutaneous insulin infusion) and followed for 12 months.

RESULTS

Twenty-nine participants completed the study. Baseline characteristics, including glycaemic metrics, were comparable across groups (p>0.05). The AHCL group demonstrated a rapid and sustained improvement in glycaemic management, with time in range increasing from 57.4% at baseline to 79.7% at 12 months (p<0.001), accompanied by reductions in hyperglycaemia as reflected by time above range and time above range 2 (nominal p<0.001; p<0.001), and with no increase in hypoglycaemia across time below range and time below range 2 (nominal p=0.463; p=1). Adjusted between-group differences favoured AHCL for time in range (15.7% [95% CI 8.6, 22.6]) and HbA1c (-5 mmol/mol; [95% CI -9.7, -0.4 mmol/mol] [-0.46%; -0.89%, -0.04%]). No serious adverse events or episodes of diabetic ketoacidosis or severe hypoglycaemia occurred. Post-occlusive reactive hyperaemia showed a shortening of time to maximal flow in the AHCL group, indicating a favourable numerical trend towards improved microvascular function (nominal p>0.05). Retinal vascular status assessed using artificial intelligence remained stable throughout follow-up in both eyes (nominal p=0.710 and p=0.563, respectively).

CONCLUSIONS/INTERPRETATION: The MiniMed 780G system appears effective for glycaemic management and safe for use in older adults with long-standing type 1 diabetes and a high burden of comorbidities. A non-statistically significant numerical tendency (p>0.05) in the improvement of vascular function that requires further confirmation was also observed.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06207838.