Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study

Background: Older adults with type 1 diabetes (T1D) have distinct characteristics that can make optimising glycaemic control challenging. We hypothesised that hybrid closed-loop is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with T1D. Methods: In an open-label multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with T1D using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX) and SAP therapy in random order. Block randomisation using central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3.9 and 10.0mmol/L. Analysis was by intention to treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. Findings: Thirty-seven participants (mean±SD age 67±5 years, baseline HbA1c 7.4±0.9% [57±10mmol/mol]) were randomised between 4 September 2019 and 2 October 2020. The proportion of time glucose was between 3.9 and 10.0mmol/L was 8.6 percentage points (95% CI 6.3 to 11.0) higher during closed-loop compared to SAP (p10.0mmol/L was 8.5 percentage points lower (95% CI -10.9 to -6.1; p<0.0001), mean glucose was 0.7mmol/L lower (95% CI -0.9 to -0.5; p<0.0001), and glycated haemoglobin was 0.2% lower (95% CI -0.4 to -0.1; p=0.00077) with closed-loop than with SAP. Time in hypoglycaemia (