Lower Rate of Initial Failures and Reduced Occurrence of Adverse Events with a New Catheter Model for Continuous Subcutaneous Insulin Infusion: Prospective, Two-Period, Observational, Multicenter Study

Abstract

Background: No recent clinical data on the incidence of catheter-related adverse events under insulin pump therapy have been reported. Methods: This was a prospective, two-period, observational, multicenter study in 45 diabetes outpatients (mean continuous subcutaneous insulin infusion [CSII] use, 6 years; mean hemoglobin A1c, 7.7%, at baseline). During the initial 1-month period (P1), the patients used their current catheter model, including a soft cannula in 98% of cases. They moved then to the new Accu-Chek^® FlexLink catheter model (Disetronic Medical Systems AG, Burgdorf, Switzerland) for a 3-month period. The primary end point, including insertion failures and unexplained hyperglycemia within the first 6 h after catheter placement, was assessed from logbook records during P1 and the last month of the second period (P2). Secondary end points were catheter replacements for unexplained hyperglycemia and/or events at risk for immediate insulin delivery failure after the first 6 h. Results: Forty-five initial infusion failures occurred in 14 patients among 507 catheter insertions (8.9% of cases) during P1, whereas 15 similar events were seen in nine patients during P2 among 488 catheter insertions (3.1% of cases) (P < 0.001). Catheters were replaced for later infusion troubles in 8% of cases during both P1 and P2. The overall rate of late cumulative events was, however, 113 of 507 (P1) versus 66 of 488 (P2) (P < 0.001). The occurrence of pain, skin reaction, or redness at the infusion site was lower during P2. Conclusion: Incidences both of initial failures and of premature catheter replacements were 8–9% with current CSII catheters. Significantly reduced failures after insertion and adverse events at the infusion site were observed with the new catheter model.