Background: We evaluated the effect of long-term intensive metabolic control with hybrid closed loop on residual C-peptide secretion and glucose control compared to standard insulin therapy in youth with type 1 diabetes over 48 months.
Methods: Following the 24 month primary phase of a multicentre, randomised, parallel trial of 96 newly diagnosed youth aged 10-16.9 years, participants entered an extension phase using either hybrid closed-loop with Cambridge algorithm (CL) or standard insulin therapy (control) until 48 months post diagnosis. Analysis was intention-to-treat.
Results: At 24 months after diagnosis, 81 participants (mean±SD age 12±2 years) continued in the extension (47 CL). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 0.3±0.5 vs control: 0.3±0.8pmol/L per mg/dL; mean adjusted difference ‑0.1 [95% CI ‑0.4, 0.2; p=0.54]). Central lab HbA1c remained lower in CL group by 10mmol/mol [0.9%] (95% CI 3, 17 [0.2, 1.5%]; p=0.01) at 48 months. Eleven severe hypoglycaemic events (6 CL, 5 control) and seven DKA occurred (3 CL, 4 control).
Conclusions: Improved glycaemic control was sustained over 48 months after diagnosis with closed loop insulin delivery compared to standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.
J. Ware: Other Relationship; Novo Nordisk, Ypsomed AG. C.K. Boughton: Consultant; CamDiab. Speaker's Bureau; Ypsomed AG. J.M. Allen: None. M.E. Wilinska: Consultant; CamDiab. S. Hartnell: Speaker's Bureau; Ypsomed AG. Employee; CamDiab. A. Thankamony: None. T. Randell: Consultant; Abbott. Speaker's Bureau; Novo Nordisk. R. Besser: Advisory Panel; Provention Bio, Inc. Speaker's Bureau; Medscape, Health Partners Institute. A. Ghatak: None. D. Elleri: None. N. Trevelyan: None. F. Campbell: None. J. Sibayan: None. R. Bailey: None. P. Calhoun: None. G.J. Dunseath: None. R. Hovorka: Other Relationship; CamDiab. Research Support; Abbott, Dexcom, Inc., Ypsomed AG. Speaker's Bureau; Ypsomed AG, Abbott, Novo Nordisk, Novartis Pharmaceuticals Corporation.
NIHR EME (14/23/09); Helmsley Trust (2016PG-T1D045 and 2016PG-T1D046); JDRF (22-2013-266 and 2-RSC-2019-828-M-N); National Institute for Health Research Cambridge Biomedical Research Centre