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DiabetesMine University 2019: Insulin Infusion Set Innovation

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* Part of the first-ever DIABETESMINE CLOSED LOOP SYSTEMS SHOWCASE *

Mark Estes of Capillary Bio provides an excellent overview of new infusion set and cannula technology for diabetes devices at the Fall 2019 DiabetesMine D-Data ExChange.

Published in: Healthcare
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DiabetesMine University 2019: Insulin Infusion Set Innovation

  1. 1. Making Infusion Sets Great (again?) “Insulin Infusion Set: The Achilles Heel of Continuous Subcutaneous Insulin Infusion“, - Lutz Heinemann and Lars Krinelke
  2. 2. Mark Estes BSME, MSIA 32+ years of med device development/ marketing/ strategy 5+ years at Minimed (pumps, sensors, infusion sets, software) 11 years at Asante (the snap pump) 3+ years at Capillary Biomedical Disclosures: Employed by and invested in Capillary Bio (infusion set development) Consult for Tidepool (loop development) Artist working in wood, leds and microcontrollers
  3. 3. Infusion Sets Have Not Kept Pace With Other Diabetes Technology Innovations  Mid 1990s: Soft cannula  Late 1990s: Quick release  Late 1990s: Insertion tools  Early 2000s: All in one inserter / package De-evolution:  Proprietary connections
  4. 4. Cannula Failure 45% Pain at Infusion Site 20% Accdentally Pulled Out 20% Adhesive Failure 9% Infection 6% Opportunities to improve infusion sets  Patel et al…  Cannula reliability  Pain reduction  Eradication of doorknobs, cats, large boxes, children, gravity, and seatbelts  Adhesive improvement  Infection reduction  Usability  Scar prevention  Waste reduction  ≥15% Fail on 1st Day  ≥25% Fail by 3rd Day  ≥65% Fail by 7th Day Source: Patel et al, J Diab Tech Therapeutics 2014
  5. 5. How Do Catheters Fail? Catheter Failure 45%  Insertion/ installation failures  Kinking during use  Occlusion  Leakage to skin  Absorption issues  Cannula = Splinter + Irritant (Preservative)  Inflammation = Wound response  Insulin does not reach capillaries
  6. 6. Improved Reliability Can Lead to Extended Duration Of Use  The pathway to extended duration:  Demonstrate similar reliability at target duration vs current devices at day 3  Benefits of extended duration of use:  less waste, less insulin, less effort, less hassle and worry  No added cost: fewer sets per box, same total duration and price  Other possible benefits  Sensor –Set combinations become viable @ ~10 days  Reduced scar tissue formation/ site preservation  Improved patch pumps (they have cannula issues also)
  7. 7. New Approaches To Cannula Design For Improving Infusion Set Reliability Medtronic drug coated Unomedical Coated Lantern Cap Bio SteadiFlow Primary design improvement Drug coating inside tubing Slits in cannula that open when kinked, coating Flexible, kink- proof cannula with 3 side ports Cannula Material Teflon Teflon Soft Nylon, coil reinforced Insertion Angle 90 90 35 Insertion Device Mio Advance Mio Advance SteadiSet Targeted Duration of use 7 days 7 days 7 days CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
  8. 8. New Insertion Devices May Help Reduce Insertion Failures Unomedical Mio Advance Capillary Bio SteadiSet  One handed insertion increases site location possibilities  Tape down before insertion stabilize insertion process  Hidden needle/ sharp-safe design  Automatic needle withdrawal after insertion  Minimal steps to deploy  Disposable CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
  9. 9. Cap Bio’s SteadiSet Goals: Reliable extended use infusion set  Kink-proof, multi-port, soft cannula designed to improve cannula reliability (insertion, kinking and occlusion)  Soft cannula to reduce inflammation response  Multiport design to spread out the insulin and improve capillary access while reducing preservative concentration in tissue  Reduce pain (insertion and wear), Reduce waste, Improve usability CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE. 9
  10. 10. Cap Bio Cannula Reduces Inflammation Thickness vs Teflon Cannula 10CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE. Histological Comparison ofTissue Response to Investigational and Comm Continuous Subcutaneous Insulin Infusion (CSII) Sets in Live S Jeffrey I Joseph D.O.1 ,Aleksandr Dinesen1 ,Abdurizzagh Khalf1 , Gabriella Eisler1 ,Channy Loeum1 ,Marc C Torjman Ph.D.1 ,and Paul JStrasma2 1.Jeffers on A rtifici al Pancr eas C enter,D epartm ent ofA nes thes iology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 2.Capillary Biomedical Inc.,Irvine,CA INTRODUCTION RESULTS • Over 1 million people with diabetesrely upon an insulin pump and continuoussubcutaneoustissue insulin infusion (CSII) through an infusion set with indwellingcannulafor adequate blood glucose control. • Patientsare educated to insert anew CSII set every 2–3 days because insulin absorption from the subcutaneoustissue into the circulation becomesincreasingly variable and unreliable over time;leadingto an increased risk for developinghyperglycemia, hypoglycemia,glycemic variability,and diabetic ketoacidosis1-4 . • Previousstudiesfrom thisgroup identifie d alayer of inflam ma tor y tissue surroundingimplanted CSII cannulaswhich becomesthicker, denser,and more continuousasduration of implant increases. • Initial insertion of aCSII cannulathrough the skin into the subcutaneoustissue damagescells,connective tissue and extracellular matrix. • A layer of thrombusand inflam ma tor y tissue developsacutely around the cannuladue to insertion trauma,motion induced trauma,and the pro-infla m ma tor y effectsof excipientsin the insulin formulation. Figure 1a. Channel from aCapBio CSII cannulaafter 6 days indwellingwith infla m ma tor y layer thicknessmeasurements. Figure 1b. Channel from aTefn indwellingwith inflama tor y la Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA 2.Capillary Biomedical Inc.,Irvine,CA INTRODUCTION RESULTS • Over 1 million people with diabetesrely upon an insulin pump and continuoussubcutaneoustissue insulin infusion (CSII) through an infusion set with indwellingcannulafor adequate blood glucose control. • Patientsare educated to insert anew CSII set every 2–3 days because insulin absorption from the subcutaneoustissue into the circulation becomesincreasingly variable and unreliable over time;leadingto an increased risk for developinghyperglycemia, hypoglycemia,glycemic variability,and diabetic ketoacidosis1-4 . • Previousstudiesfrom thisgroup identifie d alayer of inflam ma tor y tissue surroundingimplanted CSII cannulaswhich becomesthicker, denser,and more continuousasduration of implant increases. • Initial insertion of aCSII cannulathrough the skin into the subcutaneoustissue damagescells,connective tissue and extracellular matrix. • A layer of thrombusand inflam ma tor y tissue developsacutely around the cannuladue to insertion trauma,motion induced trauma,and the pro-infla m ma tor y effectsof excipientsin the insulin formulation. • Thislayer consistsof coagulated blood,edemaflui d, damaged connective tissue,cellular debris,neutrophils,macrophages,and fib r ob lasts. • Thislayer of infla m ma tor y tissue may change over time from thin, sparse,and discontinuousto thick,dense,and continuous5 . • Thislayer may function asamechanical barrier,slowingor inhibitingthe movement of insulin into adjacent subcutaneous tissue containingcapillary and lymph vessels. • Insulin infused through the CSII cannulamovesinto the infla m ma tor y tissue and adjacent healthy vascular tissue along the path of least resistance. • The dose-to-dose,site-to-site variability and overall trend of decreasinginsulin absorption asafunction of the duration of infusion set wear time in CSII therapy may be related to the location of insulin moleculesrelative to functioningcapillary and lymph vessels,variable capillary blood flow,variable rate of insulin transport acrossthe endothelium,variable lymph flow, degradation by proteaseswithin the wound and/or lymph nodes, and insulin movement upward onto the skin surface. THICKNESSOFTHE INFLAMMATORY LAYER • There wasastatistically significa nt difference (p<0.001) between the 2 groupsin the mean infla m ma tor y layer’sthicknessover the 14-day period.Analysisof the histology imagesrevealed signific a nt l y (p<0.001) thinner inflam ma tor y tissue around the CapBio CSII cannulascompared with the commercial CSIITeflon cannulasfor Days4–14 post insertion. • The thicknessof inflam ma tor y tissue around the CapBio cannulasstabilized after two days,but continued to increase around the commercial CSII cannulasuntil Day 6.The observed difference persisted from Days8–14. TOTAL SURFACEAREA OF INFLAMMATION • The internal consistency of the scoresfrom the 2 raterswashigh asassessed by aCronbach’sAlphacoeffici ent of 0.986. • There wasastatistically significa nt difference (p<0.001) between the 2 groupsin the total surface areaof inflam ma tion over the 14-day period. Teflon cannulas’surface areaof inflam ma tion was signific a nt l y (p<0.05) higher than CapBio for Days10–14 days post insertion. Figure 1a. Channel from aCapBio CSII cannulaafter 6 days indwellingwith infla m ma tor y layer thicknessmeasurements. Figure 1b. Channel from aTeflon control cannulaafter 6 days indwellingwith infla m ma tor y layer thicknessmeasurements. InflammationThickness(mm) Days After Insertion
  11. 11. Additional Ports Double The Surface Area Of Insulin / Tissue Interface & Provide Redundant Delivery Paths 11 0 50 100 150 200 250 300 350 SteadiFlow Teflon Surface Area of 7U Bolus (mm2) p=0.05 n=51 11CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE. 7U Bolus Micro-CT
  12. 12. Capillary Biomedical Status  Infusion set and Insertion device design complete. Great usability  Working through bio-compatibility and drug safety testing to support clinicals (IDE) and 510(k) submission  Feasibility studies underway OUS, first subjects NEXT WEEK!!  US clinical trials being planned to support 510(K) filing  Planning additional crossover PK/PD vs. duration study (funded by the NIH)  Finishing V and V, Developing manufacturing capability and distribution relationships, raising funds CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
  13. 13. Questions

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