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: <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: (-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.