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Aims: We evaluated efficacy and safety of fully automated closed-loop compared with standard insulin therapy in adults with type 2 diabetes (T2D) requiring maintenance dialysis.

Methods: In an open-label, multinational, two centre, randomised, crossover study, 26 adults with T2D requiring dialysis (10 females, mean±SD: age 68±11y, diabetes duration 20±10y) underwent two 20-day periods of unrestricted living, comparing CamAPS HX fully closed-loop system using Fiasp (CL), with standard insulin (control) in random order. Trial registration NCT04025775.

Results: The proportion of time in target glucose range (5.6 to 10.0mmol/L; primary endpoint) was 52.8±12.5% with CL vs. 37.7±20.5% with control; mean-adjusted difference -15.1 [95%CI -22.1 to -8.1%]; P<0.001). Mean glucose was lower with CL than control (10.1±1.3 vs. 11.6±2.8mmol/L; P=0.002). Time in hypoglycaemia was reduced with CL vs. control (<3.9mmol/L; median[IQR] 0.1[0.0-0.4%] vs. 0.2[0.0-0.9%]; P=0.040). Total daily insulin requirements were similar between interventions. One episode of severe hypoglycaemia occurred in the CL period but not during CL operation.

Conclusions: Fully closed-loop improved glucose control and reduced hypoglycaemia compared to standard insulin therapy in adults with T2D requiring dialysis.

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Disclosure

C. K. Boughton: None. R. Hovorka: Research Support; Self; Abbott Laboratories, Dexcom, Inc., Medtronic, Speaker’s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Stock/Shareholder; Self; CamDiab Ltd. L. Bally: None. S. Hartnell: Advisory Panel; Self; Medtronic, Other Relationship; Self; Ask Diabetes Ltd, Research Support; Self; CamDiab Ltd., Speaker’s Bureau; Self; Sanofi. A. Tripyla: None. D. Herzig: None. A. B. Daly: None. M. E. Wilinska: Consultant; Self; CamDiab Ltd. C. Czerlau: None. A. Fry: None.

Funding

Dexcom, Inc.; Novo Nordisk UK Research Foundation; Swiss Kidney Foundation; Swiss Society of Diabetes and Endocrinology; National Institute for Health Research; Cambridge Biomedical Research Centre; UK Wellcome Trust (100574/Z/12/Z)

© 2021 by the American Diabetes Association
2021
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