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Randomized Controlled Trial
. 2024 Dec 1;47(12):2189-2195.
doi: 10.2337/dc24-1313.

Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial

Julia Ware  1   2 , Janet M Allen  1   2 , Charlotte K Boughton  1   3 , Malgorzata E Wilinska  1   2 , Sara Hartnell  3 , Ajay Thankamony  2 , Carine de Beaufort  4   5   6 , Fiona M Campbell  7 , Elke Fröhlich-Reiterer  8 , Maria Fritsch  8 , Sabine E Hofer  9 , Thomas M Kapellen  10 , Birgit Rami-Merhar  11 , Martin Tauschmann  11 , Roman Hovorka  1   2 ; KidsAP Consortium
Collaborators, Affiliations
Randomized Controlled Trial

Eighteen-Month Hybrid Closed-Loop Use in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Trial

Julia Ware et al. Diabetes Care. .

Abstract

Objective: We aimed to evaluate the longer-term safety and efficacy of hybrid closed-loop (CL) therapy in very young children with type 1 diabetes (T1D).

Research design and methods: Following a 16-week multinational, randomized crossover trial comparing hybrid CL with sensor-augmented pump (SAP) therapy in 74 very young children aged 1-7 years with T1D, participants were invited to an extension phase using CL for a further 18 months. Outcomes were compared with the primary-phase SAP period and primary-phase CL period.

Results: After the primary study phase, 60 participants were eligible to enroll in the extension. Of these, 49 consented (mean ± SD age 6.6 ± 1.5 years) to continue use of CL for 18 months. Percentage time in range (TIR) 3.9-10.0 mmol/L was 8.4 percentage points (95% CI 6.7-10.1; P < 0.001) higher, while HbA1c was 0.4% ([5.0 mmol/mol], 95% CI 0.3-0.6 [3.7-6.2]; P < 0.001) lower during the CL extension phase compared with primary-phase SAP period. At 18 months, mean HbA1c was 6.7 ± 0.5% and TIR was 70 ± 7%, compared with 6.7 ± 0.5% and 71 ± 6% in the primary-phase CL period. Time in hypoglycemia (<3.9 mmol/L) was similar between CL extension phase and both primary-phase SAP (P = 0.31) and CL periods (P = 0.70). There were two severe hypoglycemia events and one other serious adverse event during the extension phase. One unexpected serious adverse device effect occurred.

Conclusions: Use of the Cambridge hybrid CL system led to sustained improvements in glycemic control lasting more than 18 months in very young children with T1D.

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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 has received training honoraria from Medtronic and Sanofi and consulting fees for CamDiab. F.M.C. has received speaking fees from Abbott, Medtronic, and Eli Lilly. E.F.-R. has received speaker honoraria from Eli Lilly, Medtronic, Merck, and Sandoz, and has served on advisory boards for Eli Lilly and Sanofi. S.E.H. declares speaker honoraria from Eli Lilly, Dexcom, Insulet, and Sanofi. T.M.K. has received speaker honoraria from Minimed Medtronic, Roche, and Eli Lilly and consulted with Sanofi-Aventis. B.R.-M. has received speaker honoraria from Abbott, Dexcom, Insulet, Minimed Medtronic, Eli Lilly, Sanofi, Ypsomed, and Novo Nordisk, and has served on advisory boards for Eli Lilly, Dexcom, Sanofi, and Abbott. M.T. has received speaker honoraria from Eli Lilly, Medtronic, and Ypsomed, and has served on advisory boards for Abbott and Sanofi. R.H. has received speaker honoraria from Eli Lilly, Dexcom, and Novo Nordisk; has received license and/or consultancy fees from B. Braun and Abbott Diabetes Care; holds patents related to closed-loop; and has been director at CamDiab. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Box plots of glycemic outcomes during the CL extension phase in 3-monthly intervals. Time point 0 represents the end of the 16-week CL period in the primary study phase for participants consented to the extension phase. (A) HbA1c, (B) percentage time in target range 3.9 to 10.0 mmol/L, (C) percentage time below range <3.9 mmol/L, and (D) mean sensor glucose. The black plus signs denote the mean values, the horizontal bars the median values, and the lower and upper boundaries of each box denote the 25th and 75th percentiles, respectively.
See this image and copyright information in PMC

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