1. Sustained 3-Year Improvement of Glucose Control With Hybrid Closed Loop in Children With Type 1 Diabetes While Going Through Puberty.
- Author
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Bismuth É, Tubiana-Rufi N, Rynders CA, Dalla-Vale F, Bonnemaison E, Coutant R, Farret A, Poidvin A, Bouhours-Nouet N, Storey C, Donzeau A, DeBoer MD, Breton MD, Villard O, and Renard É
- Subjects
- Humans, Child, Female, Male, Prospective Studies, Adolescent, Glycemic Control methods, Glycated Hemoglobin metabolism, Insulin Infusion Systems, Insulin therapeutic use, Insulin administration & dosage, Hypoglycemic Agents therapeutic use, Hypoglycemic Agents administration & dosage, Body Mass Index, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 1 blood, Blood Glucose metabolism, Blood Glucose drug effects, Puberty
- Abstract
Objective: To evaluate the impact of prolonged hybrid closed loop (HCL) use in children with type 1 diabetes (T1D) on glucose control and BMI throughout pubertal progression., Research Design and Methods: We used a prospective multicenter extension study following the Free-Life Kid AP (FLKAP) HCL trial. The 9-month previously reported FLKAP trial included 119 prepubertal children (aged 6-12 years). During the extension study, participants could continue to use HCL for 30 months (M9 to M39). HbA1c values were collected every 3 months up to M39, while continuous glucose monitoring metrics, BMI z scores, and Tanner stages were collected up to M24. Noninferiority tests were performed to assess parameter sustainability over time., Results: One hundred seventeen children completed the extension study, with mean age 10.1 years (minimum to maximum, 6.8-14.0) at the beginning. Improvement of HbA1c obtained in the FLKAP trial was significantly sustained during extension (median [interquartile range], M9 7.0% [6.8-7.4], and M39 7.0% [6.6-7.4], P < 0.0001 for noninferiority test) and did not differ between children who entered puberty at M24 (Tanner stage ≥2; 54% of the patients) and patients who remained prepubertal. BMI z score also remained stable (M9 0.41 [-0.29 to 1.13] and M24 0.48 [-0.11 to 1.13], P < 0.0001, for noninferiority test). No severe hypoglycemia and one ketoacidosis episode not related to the HCL system occurred., Conclusions: Prolonged use of HCL can safely and effectively mitigate impairment of glucose control usually associated with pubertal progression without impact on BMI in children with T1D., (© 2024 by the American Diabetes Association.)
- Published
- 2024
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