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

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 DPV registry included data from 3,657 patients with diabetes (n=3,582 type 1, n=25 type 2, n=50 LADA/other) treated with a tubeless insulin pump. HbA1c levels and frequency of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) were compared between one year pre- and 1 year (n=2,911) or up to 3 years (n=1,311) post-tubeless insulin pump initiation and compared to a contemporary cohort on MDI with 3year data (n=1,874). RESULTS Patients using tubeless insulin pump therapy had a median age of 13.7 yr. [IQR 10.8, 17.3], diabetes duration 3.7 yr. [1.7, 8.0], and HbA1c 7.5% [6.9, 8.2]. In patients with 3 years of follow-up data (n=1,311), 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 to MDI after adjustment in multiple regression analysis. High treatment retention rates (>90%) were observed. CONCLUSION Real-world registry data documents 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.