Sustained 3-year improvement of glucose control with hybrid closed-loop in children with type 1 diabetes while going through puberty

Abstract

<p dir="ltr">Objective. To evaluate the impact of prolonged hybrid closed-loop (HCL) use in children with type 1 diabetes (T1D) on glucose control and body mass index (BMI) throughout pubertal progression.</p><p dir="ltr">Research Design and Methods. Prospective multicenter extension study following 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 (CGM) metrics, BMI Z-scores and Tanner stages were collected up to M24. Non-inferiority tests were performed to assess parameters sustainability over time.</p><p dir="ltr">Results. 117 children completed the extension study with mean age 10.1 years [min-max 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 non-inferiority 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 [-0.29-1.13] and M24: 0.48 [-0.11-1.13], p<0.0001, for non-inferiority test). No severe hypoglycemia and one ketoacidosis episode not related to the HCL system occurred.</p><p dir="ltr">Conclusion. 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.</p>