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Randomized Controlled Trial
. 2024 Aug 1;47(8):1441-1448.
doi: 10.2337/dc24-0360.

Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial

Julia Ware  1   2 , Charlotte K Boughton  1   3 , Janet M Allen  1   2 , Malgorzata E Wilinska  1   2 , Sara Hartnell  3 , Ajay Thankamony  2 , Tabitha Randell  4 , Atrayee Ghatak  5 , Rachel E J Besser  6   7 , Daniela Elleri  8 , Nicola Trevelyan  9 , Fiona M Campbell  10 , Judy Sibayan  11 , Ryan Bailey  11 , Peter Calhoun  11 , Gareth Dunseath  12 , Roman Hovorka  1   2 ; CLOuD Consortium
Collaborators, Affiliations
Randomized Controlled Trial

Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial

Julia Ware et al. Diabetes Care. .

Abstract

Objective: We evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months.

Research design and methods: Following the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat.

Results: At 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase.

Conclusions: Improved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.

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Conflict of interest statement

Duality of Interest. J.W. has received speaker honoraria from Ypsomed and Novo Nordisk. C.K.B. has received consulting fees from CamDiab and speaker honoraria from Ypsomed. M.E.W. reports patents related to closed-loop and being a consultant at CamDiab. S.H. serves as a member of Medtronic advisory board, is a director of Ask Diabetes Ltd providing training and research support in health care settings, and reports having received training honoraria from Medtronic and Sanofi and consulting fees for CamDiab. T.R. receives consultancy fees from Abbott Diabetes care and has received honoraria from Novo Nordisk for delivering educational meetings. R.E.J.B. reports receiving speaker honoraria from Eli Lilly and Springer Healthcare, reports sitting on the Novo Nordisk UK Foundation Research Selection Committee on a voluntary basis, acted as an independent advisor for Provent Bio, and received speaking honoraria from Sanofi and Medscape, which were donated to an education research fund. R.H. reports receiving speaker honoraria from Eli Lilly, Dexcom, and Novo Nordisk, receiving license and/or consultancy fees from B. Braun and Abbott Diabetes Care, patents related to closed-loop, and being director at CamDiab. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
A: Longitudinal fasting C-peptide adjusted for fasting plasma glucose. B: Longitudinal HbA1c. The numbers beneath the x-axis in B reflect the number of participants in the control group using different types of diabetes technology at each time point (sensor includes real-time and flash glucose monitoring). The ɪ bars represent interquartile ranges.
See this image and copyright information in PMC

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