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管饲胰岛素泵使用相关急性并发症的发生频率下降:来自德国/奥地利糖尿病患者病程记录登记处的 2911 例患者的数据。

Declining Frequency of Acute Complications Associated with Tubeless Insulin Pump Use: Data from 2,911 Patients in the German/Austrian Diabetes Patienten Verlaufsdokumentation Registry.

机构信息

AUF DER BULT Diabetes Center for Children and Adolescents, Hannover, Germany.

Institute for Epidemiology and Medical Biometry,ZIBMT,Ulm University, Ulm, Germany.

出版信息

Diabetes Technol Ther. 2021 Aug;23(8):527-536. doi: 10.1089/dia.2020.0675. Epub 2021 Jul 23.

Abstract

To characterize patients with diabetes treated with a tubeless insulin pump (Omnipod Insulin Management System; Insulet Corp., Acton, MA), and to evaluate the frequency of acute complications with long-term use of the system. This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registry included data from 3657 patients with diabetes ( = 3582 type 1,  = 25 type 2,  = 50 latent autoimmune diabetes in adults/other) treated with a tubeless insulin pump. Hemoglobin A1c (HbA1c) levels and frequency of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) were compared between 1 year pre- and 1 year ( = 2911) or up to 3 years ( = 1311) post-tubeless insulin pump initiation and compared with a contemporary cohort on multiple daily injections (MDI) with 3-year data ( = 1874). Patients using tubeless insulin pump therapy had a median age of 13.7 years [interquartile range 10.8, 17.3], diabetes duration 3.7 years [1.7, 8.0], and HbA1c 7.5% [6.9, 8.2]. In patients with 3 years of follow-up data ( = 1311), the percentage with ≥1 episode of DKA, SH (Level 3, requiring assistance), and SH (coma) event with prior treatment was 6.3%, 5.5%, and 1.7%, respectively. After 3 years of tubeless insulin pump therapy, the frequency of DKA, SH (Level 3), and SH (coma) decreased to 2.2%, 4.1%, and 0.5%, respectively. Both DKA and SH remained significantly lower compared with MDI after adjustment in multiple regression analysis. High treatment retention rates (>90%) were observed. Real-world registry data document that tubeless insulin pump therapy is associated with good glycemic control and a low frequency of DKA and SH in an age group prone to acute complications.

摘要

为了描述使用无管胰岛素泵(Omnipod Insulin Management System;Insulet Corp.,马萨诸塞州阿克顿)治疗的糖尿病患者的特征,并评估该系统长期使用时急性并发症的发生频率。这项对德国/奥地利糖尿病患者病程记录(DPV)登记处的回顾性分析纳入了 3657 名使用无管胰岛素泵治疗的糖尿病患者( = 3582 型 1 例, = 25 型 2 例, = 50 例成人隐匿性自身免疫性糖尿病/其他)的数据。比较了无管胰岛素泵治疗前 1 年和治疗后 1 年( = 2911 例)或长达 3 年( = 1311 例)时的糖化血红蛋白(HbA1c)水平和糖尿病酮症酸中毒(DKA)及严重低血糖(SH)的发生频率,并与接受多次每日注射(MDI)治疗且具有 3 年数据的同期队列( = 1874 例)进行了比较。使用无管胰岛素泵治疗的患者的中位年龄为 13.7 岁[四分位间距 10.8, 17.3],糖尿病病程 3.7 年[1.7, 8.0],HbA1c 7.5%[6.9, 8.2]。在具有 3 年随访数据的患者中( = 1311 例),既往治疗后发生≥1 次 DKA、SH(Level 3,需要帮助)和 SH(昏迷)事件的患者比例分别为 6.3%、5.5%和 1.7%。无管胰岛素泵治疗 3 年后,DKA、SH(Level 3)和 SH(昏迷)的频率分别降至 2.2%、4.1%和 0.5%。多因素回归分析调整后,DKA 和 SH 的发生率仍显著低于 MDI。观察到高治疗保留率(>90%)。真实世界登记处的数据表明,在易发生急性并发症的年龄组中,无管胰岛素泵治疗与良好的血糖控制和较低的 DKA 和 SH 发生率相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/239f/8377506/085dcc55e02d/dia.2020.0675_figure1.jpg

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