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 6h 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 6h. 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 8­9% with current CSII catheters. Significantly reduced failures after insertion and adverse events at the infusion site were observed with the new catheter model.