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