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

• Main Authors: Biester, T. (Author), Danne, T. (Author), Festa, A. (Author), Haak, T. (Author), Heidtmann, B. (Author), Kostow, S. (Author), Mönkemöller, K. (Author), Müller, A. (Author), Rami-Merhar, B. (Author), Schwandt, A. (Author)
• Format: Article
• Language: English
• Published: Mary Ann Liebert Inc. 2021
• Subjects: acute disease; adolescent; adult; Adult; adverse event; antidiabetic agent; Article; Austria; blood glucose monitoring; child; clinical feature; cohort analysis; complication; controlled study; CSII; diabetes mellitus; Diabetes Mellitus, Type 1; diabetic coma; diabetic ketoacidosis; Diabetic ketoacidosis; disease severity; DPV; drug withdrawal; epidemiology; female; follow up; glucose; Glycated Hemoglobin A; glycemic control; glycosylated hemoglobin; hemoglobin A1c; human; Humans; hypoglycemia; Hypoglycemia; Hypoglycemic Agents; insulin; Insulin; insulin dependent diabetes mellitus; insulin infusion; Insulin Infusion Systems; insulin treatment; intermethod comparison; latent autoimmune diabetes in adults; major clinical study; male; medical device complication; middle aged; morbidity; non insulin dependent diabetes mellitus; Omnipod; patch pump; preschool child; register; Registries; Retrospective Studies; retrospective study; treatment duration; young adult
• Online Access: View Fulltext in Publisher

 Objective: 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. Methods: This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registry included data from 3657 patients with diabetes (n = 3582 type 1, n = 25 type 2, n = 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 (n = 2911) or up to 3 years (n = 1311) post-tubeless insulin pump initiation and compared with a contemporary cohort on multiple daily injections (MDI) with 3-year data (n = 1874). Results: 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 (n = 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. Conclusion: 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. © Torben Biester, et al., 2021; Published by Mary Ann Liebert, Inc. 2021.