Is Automated Insulin Delivery System Therapy Safe and Effectıve in Children Under 7 Years Old?

IF 1.5 4区 医学 Q4 ENDOCRINOLOGY & METABOLISM
Nihal Gul Uslu, Deniz Ozalp Kizilay, Gunay Demir, Yasemin Atik Altinok, Sukran Darcan, Samim Ozen, Damla Göksen
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Abstract

Objectives: This study aims to evaluate the off-label use of the MiniMed™ 780G system in children under seven years old, as clinical outcomes in this age group are less established despite the improvements in glycemic control seen with MiniMed™ 780G therapy.

Methods: Children under seven years old with type 1 diabetes (T1D) using MiniMed™ 780G pump therapy were retrospectively compared with children of similar age and gender using MiniMed™ 640G insulin pump therapy and multiple-dose insulin (MDI) therapy with continuous glucose monitoring systems (CGMs). CGM metrics, total daily insulin dose (TDI), and HbA1c levels were evaluated retrospectively at baseline and at the 3rd, 6th, and 12th months.

Results: At the initiation of MiniMed™ 780G therapy, the mean age was 5,25±1,22 years (range: 2,8-6,8 years), and the mean TDI was 10,12±4,34 U/day (range: 4,5-17 U/day). The glucose management indicator (GMI) and HbA1c remained lower in the MiniMed™ 780G group at the 3rd, 6th, and 12th months compared to baseline (p=0,009 and p<0,001, respectively). In the MiniMed™ 780G group, Time Above Range (TAR) was significantly lower at the 3rd, 6th, and 12th months (p=0,018, 0,017, and 0,04, respectively), and Time in Range (TIR) was higher at the 3rd and 12th months (p=0,026 and 0,019, respectively). The coefficient of variation (CV) and HbA1c were lower at the 12th month (p=0,008 and 0,015, respectively) compared to the other groups. No instances of ketoacidosis or severe hypoglycemic events were observed in any of the children during the follow-up period.

Conclusions: The absence of significantly higher levels of hypoglycemia compared to other groups at any time point, along with a significant decrease in TAR across all time points, a significant increase in TIR at the 3rd and 12th months, and a significant decrease in HbA1c and CV, indicates that the MiniMed™ 780G system is both safe and effective for children under seven years old.

自动胰岛素输送系统疗法对 7 岁以下儿童是否安全有效?
研究目的本研究旨在评估 MiniMed™ 780G 系统在七岁以下儿童中的标示外使用情况,因为尽管 MiniMed™ 780G 治疗可改善血糖控制,但该年龄组的临床结果尚不确定:方法:对使用 MiniMed™ 780G 泵疗法的七岁以下 1 型糖尿病(T1D)患儿与使用 MiniMed™ 640G 胰岛素泵疗法和多剂量胰岛素 (MDI) 并使用连续血糖监测系统 (CGM) 的年龄和性别相仿的患儿进行了回顾性比较。对 CGM 指标、每日胰岛素总剂量 (TDI) 和 HbA1c 水平进行了基线和第 3、6 和 12 个月的回顾性评估:开始使用 MiniMed™ 780G 治疗时,患者的平均年龄为(5.25±1.22)岁(范围:2.8-6.8 岁),平均每日胰岛素总剂量为(10.12±4.34)U/天(范围:4.5-17 U/天)。与基线相比,MiniMed™ 780G 组在第 3 个月、第 6 个月和第 12 个月的血糖管理指标(GMI)和 HbA1c 仍然较低(p=0,009 和 p结论:与其他组相比,MiniMed™ 780G 系统在任何时间点都没有明显较高的低血糖水平,同时在所有时间点 TAR 都明显下降,在第 3 个月和第 12 个月 TIR 明显上升,HbA1c 和 CV 明显下降,这表明 MiniMed™ 780G 系统对 7 岁以下儿童既安全又有效。
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来源期刊
Journal of Clinical Research in Pediatric Endocrinology
Journal of Clinical Research in Pediatric Endocrinology ENDOCRINOLOGY & METABOLISM-PEDIATRICS
CiteScore
3.60
自引率
5.30%
发文量
73
审稿时长
20 weeks
期刊介绍: The Journal of Clinical Research in Pediatric Endocrinology (JCRPE) publishes original research articles, reviews, short communications, letters, case reports and other special features related to the field of pediatric endocrinology. JCRPE is published in English by the Turkish Pediatric Endocrinology and Diabetes Society quarterly (March, June, September, December). The target audience is physicians, researchers and other healthcare professionals in all areas of pediatric endocrinology.
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