What question did this study set out to answer?

To evaluate the feasibility, safety, and efficacy of automated insulin delivery in managing glucose levels for individuals with diabetes and advanced chronic kidney disease.

May 12, 2026Diabetologia0 citationsOpen Access

The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease

JLJean C. LuThe University of Melbourne CMChristine L. Meyer‐OlesenCopenhagen University Hospital BHBella HalimThe University of Melbourne

Key Points

To evaluate the feasibility, safety, and efficacy of automated insulin delivery in managing glucose levels for individuals with diabetes and advanced chronic kidney disease.
Conducted a prospective, open-label, randomised crossover trial across six hospitals in Australia and Denmark.
Participants aged ≥18 years with type 1 or insulin-treated type 2 diabetes and advanced CKD were randomly assigned to receive either AID or usual care for 8 weeks each.
Utilized real-time continuous glucose monitoring to measure the primary outcome, percentage time in range during the final 3 weeks.
AID improved time in range from 60% (51%, 66%) with usual care to 73% (65%, 78%) (p < 0.001).
Hypoglycaemia rates remained unchanged throughout the trial.
25% of participants experienced hospital admissions for unrelated medical issues, with no serious adverse events linked to the study devices.

Abstract

Abstract 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; HbA 1c 64 54, 73 mmol/mol 8.0% (7.1%, 8.8%); eGFR 30 18, 37 ml/min per 1.73 m 2 ) 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. Graphical Abstract

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