Feasibility of an Investigational Extended Wear Infusion Set for Insulin Pump Therapy (IPT) in People with Type 1 Diabetes Mellitus

Background: Reliable insulin delivery is critical in the management of type 1 diabetes. Limitations of insulin pump therapy (IPT) are the maximum cannula life of three days, and a reported failure rate of 15-25% prior to this, which may impact glycemia and quality of life. Objective: We aimed to determine the feasibility of a prototype cannula for an extended wear infusion set. Materials and Methods: CapBio’s SteadiFlow technology (Capillary Biomedical, Irvine, CA, USA) consists of a cannula with a soft outer polymer reinforced by an internal metal coil to prevent kinking and three additional side ports to reduce the risk of cannula blockages. Adults with type 1 diabetes using IPT participated in a study with three study periods. For each period a new infusion set was inserted for an intended wear of 7 days. During Period 1 saline was infused via the investigational set through an additional insulin pump. During Periods 2 and 3 insulin lispro was delivered via the investigational set connected to the participant’s own insulin pump. Results are expressed as mean (SD). Results: Twenty participants (Medtronic 640G [n=11]; 670G [n=3]; Tandem t-slim X2 [n=6]) with type 1 diabetes (age 44Y [14]; HbA1c 7.3% [0.6]/56mmol/mol [6]; female 50%) were studied. The 7-day survival rates of the prototype cannula set were 19/20 (95%) for period one and 36/41(88%) for periods two and three combined. No serious adverse events were reported. Mild infusion site reactions occurred in 7 participants. Hyperglycemia was reported as an adverse event in 7 participants resulting in premature cannula removal in 4 cases (occurring, respectively, on Days 1, 2, 5, and 6 during Weeks 2 or 3). Infusion site infection caused the 5th premature removal (on Day 3). Post-removal, no kinked cannulas were observed. Conclusions: These study results confirm the feasibility of the extended-life investigational cannula. Larger, randomised studies are required to confirm these preliminary observations. Disclosure D. N. O’neal: Advisory Panel; Self; Abbott Diabetes, Medtronic, Sanofi, Research Support; Self; Dexcom, Inc., GlySens Incorporated, Medtronic, Pacific Diabetes Technologies. N. Venkatesh: None. K. Brown: None. E. I. Ekinci: None. S. Fourlanos: Advisory Panel; Self; Pfizer Foundation, Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company. J. R. Kastner: None. R. Macisaac: Advisory Panel; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk, Servier Laboratories, Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH, Novo Nordisk. D. B. Muchmore: Consultant; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc., Zucara Therapeutics Inc., Stock/Shareholder; Self; Capillary Biomedical, Inc., Diasome Pharmaceuticals, Inc.