Development Of Steadiflow Technology, An Advanced Insulin Delivery Cannula Featuring Extended Duration Of Use, More Reliable Insulin Delivery, And Reduced Inflammatory Tissue Response

There is great clinical need for an insulin infusion set that produces reliable and consistent insulin absorption (PK) from dose to dose and functions reliably for 7 or more days. Capillary Biomedical, Inc. is developing SteadiFlow technology which features a soft yet kink-proof cannula with 1 distal orifice and 3 additional orifices distributed over the final 6 mm of the distal end of the cannula. We compared the performance of the SteadiSet to commercial insulin infusion sets with a Teflon cannula in large ambulatory swine. Investigational infusion sets featuring SteadiFlow technology and commercial Teflon infusion set were inserted into the subcutaneous tissue of swine’s abdomen every other day for 14 days. Insulin lispro (U-5) was infused through the catheters using the same basal/bolus pattern. On day # 14, a 70 ul bolus of insulin/x-ray contrast agent was infused through each CSII catheter. The tissue surrounding each CSII was excised 5 minutes later, frozen, and imaged using a high-resolution micro-CT scanner. The tissue was then processed and stained to produce high-resolution histology images. Histology images revealed a significantly thinner and smaller area of inflammatory tissue around the SteadiSet cannulas compared with the commercial Teflon cannulas. Micro-CT images revealed a significantly larger surface area of insulin/x-ray contrast agent delivered into the adjacent tissue when infused through the SteadiSet infusion sets compared with the commercial infusion sets with a Teflon cannula. A glucose clamp PK/PD study performed in swine using SteadiSet infusion sets implanted for 6 days showed reliable performance and relatively consistent insulin absorption into the circulation. Human clinical trials are planned for early 2019 to evaluate SteadiFlow technology for reliability, glucose control performance, and PK/PD metrics in patients with type 1 diabetes. Disclosure J.I. Joseph: Advisory Panel; Self; CapillaryBiomedical, Inc., Thermalin Diabetes, Inc. Research Support; Self; Capillary Biomedical, inc., Thermalin Diabetes, Inc. Stock/Shareholder; Self; Capillary Biomedical, Inc. M.C. Torjman: Other Relationship; Self; Capillary Biomedical, Inc. C. Loeum: Stock/Shareholder; Self; Capillary Biomedical, Inc. G.J. Eisler: None. P.J. Strasma: Employee; Self; Capillary Biomedical, Inc. A. Khalf: None. Funding JDRF; Capillary Biomedical, Inc.