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 (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 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.

中文翻译：

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通过混合闭环治疗 1 型糖尿病儿童在青春期期间的血糖控制持续 3 年得到改善


目的 评估 1 型糖尿病 (T1D) 儿童长期使用混合闭环 (HCL) 对整个青春期进展过程中血糖控制和 BMI 的影响。研究设计和方法 我们在 Free-Life Kid AP (FLKAP) HCL 试验之后进行了一项前瞻性多中心扩展研究。之前报道的为期 9 个月的 FLKAP 试验包括 119 名青春期前儿童（6-12 岁）。在扩展研究期间，参与者可以继续使用 HCL 30 个月（M9 至 M39）。每 3 个月收集一次 HbA1c 值，直至 M39，同时收集连续血糖监测指标、BMI Z 分数和 Tanner 阶段，直至 M24。进行非劣效性检验以评估参数随时间的可持续性。结果 117 名儿童完成了扩展研究，开始时的平均年龄为 10.1 岁（最小-最大 6.8-14.0）。 FLKAP 试验中获得的 HbA1c 改善在扩展期间显着持续（中位数[四分位距]，M9：7.0% [6.8–7.4]，M39：7.0% [6.6–7.4]，非劣效性检验 P < 0.0001） M24 进入青春期的儿童（Tanner ≥ 2 期；54% 的患者）和仍处于青春期前的患者之间没有差异。 BMI Z 评分也保持稳定（M9：0.41 [−0.29 至 1.13] 和 M24：0.48 [−0.11 至 1.13]，P < 0.0001，非劣效性检验）。未发生严重低血糖和 1 次与 HCL 系统无关的酮症酸中毒事件。结论 长期使用 HCL 可以安全有效地减轻通常与青春期进展相关的血糖控制受损，而不影响 1 型糖尿病儿童的 BMI。