[Efficacy and safety of hybrid closed-loop insulin delivery system in treating type 1 diabetes mellitus in children].

Objective

To evaluate the efficacy of hybrid closed-loop insulin delivery system (CLS) in glycemic control in young children with type 1 diabetes mellitus (T1DM).

Methods

This retrospective observational self-controlled study analyzed data from 14 children (aged 3-9 years) with T1DM treated at the Endocrinology and Metabolism Department of Anhui Provincial Children's Hospital between August 2021 and February 2024. All the patients had undergone continuous subcutaneous insulin infusion (commonly known as insulin pump therapy) with continuous glucose monitoring system (CGMS) for at least 4 weeks and CLS for over 6 months. Data collected included age, sex, body mass index (BMI), diabetes duration, duration of insulin pump use, baseline glycated hemoglobin (HbA1C), and pre-and post-treatment glycemic metrics. Based on the duration of combined CLS therapy, groups were divided as follows: baseline (before combined CLS therapy), 0-<4 weeks, 4-<8 weeks, 8-<12 weeks, 12-<24 weeks. Independent sample t-test and ANOVA were used to compare intergroup and multigroup differences, respectively, in glycemic levels before and after hybrid CLS therapy.

Results

Among the 14 pediatric patients, 8 were male and 6 were female. Their age was (6.5±0.5) year old, BMI was (16.1±1.3) kg/m², duration of diabetes was (20.1±2.6) months, duration of CGMS insulin pump use was (13.8±2.6) months, and baseline HbA1C was (10.2±0.8)%. One-way ANOVA revealed that hybrid CLS therapy significantly improved glycemic control, compared to pre-treatment, at 6 months follow-up, the following outcomes were observed: increased time-in-range (TIR), reduced time in hyperglycemia and hypoglycemia, lower HbA1C and mean glucose level, improved daytime TIR, and decreased mean glucose levels at fasting, postprandial (three meals), and bedtime (22:00), and scores on the pediatric quality of life inventory significantly increased (F=3.16, 2.94, 2.56, 13.84, 2.36, 7.00, 40.48, 115.90, 192.50, 122.70, 75.55, t=11.00, all P<0.05).

Conclusions

Compared to baseline insulin pump therapy, hybrid CLS improves glycemic control and quality of life in young children with T1DM, while reducing the risk of hypoglycemia over a 6-month treatment period.