AUF DER BULT Diabetes Center for Children and Adolescents, Hannover, Germany.
Institute for Epidemiology and Medical Biometry,ZIBMT,Ulm University, Ulm, Germany.
Diabetes Technol Ther. 2021 Aug;23(8):527-536. doi: 10.1089/dia.2020.0675. Epub 2021 Jul 23.
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.
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。
