Hybrid closed-loop insulin delivery improves glycaemic control compared with sensor-augmented pump therapy: A meta-analysis of 'free-living' randomised trials in type 1 diabetes.

AIM: Although hybrid closed-loop systems (HCLS) and sensor-augmented pump (SAP) therapy are advanced diabetes management technologies for type 1 diabetes, their relative efficacy in optimising glycaemic control is not fully established. This meta-analysis evaluated the impact of HCLS versus SAP therapy on glucose regulation across multiple randomised controlled trials (RCTs) and randomised crossover trials (RCOs). The primary aim was to determine the efficacy of HCLS in improving glycaemic control, reducing glucose variability and enhancing time in range (TIR) compared with SAP therapy.

METHODS

The review was prospectively registered with the International Prospective Register of Systematic Reviews as CRD42023488722. Data from 27 studies involving over 1000 participants were analysed. The studies included both RCTs and RCOs that compared HCLS with SAP therapy. Key metrics assessed were mean glucose levels, glucose variability (coefficient of variation and standard deviation), low blood glucose index (LBGI), high blood glucose index (HBGI), glycated haemoglobin (HbA1c) and TIR (3.9-10.0 mmol/L). Hyperglycaemia and hypoglycaemia outcomes were also evaluated.

RESULTS

HCLS significantly reduced mean glucose levels by 2.0 mg/dL compared with SAP therapy. It also decreased glucose variability, including CV and SD, and reduced LBGI, HBGI and HbA1c. HCLS increased TIR by 8.8%. Regarding hyperglycaemia, HCLS reduced the time spent above 10 mmol/L by 7.8%, above 13.9 mmol/L by 3.63% and above 16.7 mmol/L by 0.88%. Hypoglycaemia outcomes showed modest improvements, with reductions in time below 3 mmol/L by 0.10% and below 3.9 mmol/L by 0.72%.

CONCLUSIONS

Our findings support HCLS as a superior modality to SAP therapy in improving glycaemic control, particularly in paediatric populations. HCLS effectively reduces hyperglycaemia and increases TIR, with modest effects on hypoglycaemia. The clinical implications are significant, highlighting the advantages of HCLS in optimising glucose regulation and mitigating glycaemic variability. This technology offers improved glycaemic control and enhanced quality of life for people living with type 1 diabetes.