AIMS/HYPOTHESIS: Chronic kidney disease (CKD) complicates insulin dosing and increases glycaemic instability in diabetes. We aimed to compare feasibility, safety and efficacy of automated insulin delivery (AID) with usual care in people with diabetes and advanced CKD.
METHODS: We conducted a prospective, open-label, randomised crossover trial at five tertiary hospitals in Australia and one tertiary centre in Denmark. Adults aged ≥18 years with type 1 diabetes or insulin-treated type 2 diabetes and advanced CKD (stage 3b or higher, including dialysis) were eligible. Participants were randomly assigned in a 1:1 sequence to receive either AID followed by usual care with real-time continuous glucose monitoring (CGM), or the reverse sequence, each for 8 weeks. Allocation was generated centrally using computerised randomisation. Due to the nature of the intervention, participants and clinicians were aware of treatment assignment. The primary outcome was percentage time in range (3.9-10.0 mmol/l) during the final 3 weeks of each treatment period.
RESULTS: Forty participants (24 type 1 diabetes, 16 type 2 diabetes; median [IQR] age 60 [55, 69] years; HbA64 [54, 73] mmol/mol [8.0% (7.1%, 8.8%)]; eGFR 30 [18, 37] ml/min per 1.73 m) were enrolled: 33 not on dialysis, four on peritoneal dialysis and three on haemodialysis. AID significantly improved all hyperglycaemic CGM metrics compared with usual care. Time in range (3.9-10.0 mmol/l) improved from 60% (51%, 66%) at the end of usual care to 73% (65%, 78%) at the end of AID (p<0.001). Hypoglycaemia rates were unchanged. Participants were predominantly pre-frail at baseline and remained stable on-trial. No serious adverse events were attributed to the study devices. Nonetheless, 25% of participants experienced hospital admissions during the trial period for medical issues unrelated to device use.
CONCLUSIONS/INTERPRETATION: AID is feasible and safe and compared with usual care provides superior glucose management in predominantly pre-frail people with diabetes complicated by advanced CKD.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12622000889752; ClinicalTrials.gov NCT06330194 FUNDING: This trial was funded by the Australian Centre for Advancing Diabetes Innovations (ACADI), St Vincent's Hospital Melbourne and Diabetes Australia.