BES2025 BES 2025 CLINICAL STUDIES (21 abstracts)
One-year effectiveness and safety in young children aged 2-6 years with type 1 diabetes using an advanced hybrid closed-loop system: a real-world prospective cohort study
Jolien De Meulemeester 1 , Laura Valgaerts 1 , Sylvie Tenoutasse 2 , Inge Gies 3 , Marieke den Brinker 4 , Julie Fudvoye 5 , Thierry Mouraux 6 , Jacques Louis 7 , Sophie Lambert 8 , Marlies Van Loocke 9 , Goele Smeets 10 , Annelies Lemay 11 , Sofie Ryckx 12 , Sylvia Depoorter 13 , Sara Van Aken 14 , Ellen Maris 15 , Chantal Mathieu 1 , P. Gillard 1 & K. Casteels 1
1University Hospitals Leuven - KU Leuven, Leuven; 2Hôpital Universitaire de Bruxelles - Hôpital Universitaire des Enfants Reine Fabiola, Brussels; 3Universitair Ziekenhuis Brussel, Brussels; 4University Hospital Antwerp - University of Antwerp, Edegem; 5University Hospital of Liège, Liège; 6University Hospital Center UCL Namur, Yvoir; 7Grand Hôpital de Charleroi, Charleroi; 8Clinique CHC Montlégia, Liège; 9AZ Delta, Roeselare; 10Jessa Hospital, Hasselt; 11AZ Turnhout, Turnhout; 12ZAS Paola, Antwerpen; 13AZ Sint-Jan Brugge, Bruges; 14University Hospital Ghent, Ghent; 15VITAZ, Sint-Niklaas
Purpose of the study: The MiniMed™ 780G is currently not approved for use in children with type 1 diabetes (T1D) under seven years of age. This prospective study aims to complement recent findings from the LENNY randomized controlled trial by evaluating one-year changes in glycemic management, parent-reported outcomes and safety following initiation of the MiniMed™ 780G in children aged 2-6 years with T1D in real-world clinical practice.
Methods: Children aged 2-6 years whose parents agreed to initiate the MiniMed™ 780G were enrolled at 15 Belgian centers between October 2022 and December 2023. Data were collected quarterly over one year during routine follow-up. Parent-reported outcomes were assessed using questionnaires (HAPPID and Hypoglycemia Fear Survey [HFS] – Parent). Data are reported as mean ± SD or least-squares mean (95% CI).
Results: A total of 149 children were included (mean age 4.2 ± 1.4 years; 56.4% girls). At start, mean T1D duration was 22.0 ± 13.0 months and 75.2% used an insulin pump. After one year, time in range (70-180 mg/dl) increased from 56.8% (54.4-59.2) to 66.6% (64.7-68.5) and HbA1c decreased from 7.6% (7.4-7.8) to 7.2% (7.1-7.4) (all P <0.001). Time <70 mg/dl remained stable (5.0% [4.2-5.8] at start vs 4.6% [3.9-5.3] at 12 months, P = 0.172). Parents reported less diabetes-related burden on the HAPPI-D questionnaire (22.9 points [21.7-24.0] at start vs 21.7 points [20.5-22.8] at 12 months, P = 0.001), while scores on the HFS-Parent questionnaire did not change. There were no hospitalizations for severe hypoglycemic events and one hospitalization for diabetic ketoacidosis due to infusion set occlusion.
Conclusion: One year use of the MiniMed™ 780G in children with T1D aged 2-6 years was safe and associated with improved glycemic management and reduced burden on parents, with limited impact on hypoglycemia and related parental fear. These results underscore the need to expand regulatory approval and access to hybrid closed-loop technology for this population.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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