Type 1 diabetes

Sustained 3-Year Improvement of Glucose Control With Hybrid Closed Loop in Children With Type 1 Diabetes While Going Through Puberty

Diabetes CarePublished Prospective extension study of the Free-Life Kid AP (FLKAP) hybrid closed loop (HCL) randomised trial

Authors' 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.

Study context

Population
Children with T1D, prepubertal (aged 6–12 years) at FLKAP entry, using HCL through pubertal progression; mean age 10.1 years (6.8–14.0) at extension startcompleted extension
Participants
117 children
Comparison
HbA1c and BMI z score at M39/M24 vs M9 with continued HCL
Methodological detailsmulticenter, noninferiority tests
  • Multicenter
  • Noninferiority tests

Primary result

As reported in the abstract

HbA1c · M9 vs M39

P < 0.0001 for noninferiority test

Further findings

OutcomeM9M39P value
BMI z score · M9 vs M24Value at M240.41 (IQR −0.29–1.13)0.48 (IQR −0.11–1.13)P < 0.0001, for noninferiority test
  • BMI z score: later value measured at M24

HbA1c by pubertal status at M24 (Tanner stage ≥2 vs prepubertal)

Entered puberty at M24
54%
HbA1c did not differ between children who entered puberty at M24 and those who remained prepubertal

Safety

Ketoacidosis episode not related to the HCL system
one
No severe hypoglycemia occurred

Original publication

Sustained 3-Year Improvement of Glucose Control With Hybrid Closed Loop in Children With Type 1 Diabetes While Going Through Puberty. Diabetes Care. Published 10 July 2024. doi:10.2337/dc24-0916

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