Insulin exposure and action are known to differ on each of 3 days of infusion set wear during CSII. We extend these observations to 1 week in a pilot phase study comparing conventional Teflon angled infusion sets to a prototype extended wear set using Capillary Biomedical SteadiFlow™ technology. Participants with T1DM for >12 months, A1C <8.5%, c-peptide <0.6 nmol/L, and ≥6 months use of Medtronic model 530G or higher were enrolled in a 2-period crossover euglycemic clamp study; clamps were performed after fasting overnight stabilization with IV insulin. Five men and 2 women, mean duration of diabetes 22.5 (16.6 SD) years and mean BMI 27.6 (3.8 SD) kg/m2 were enrolled; 4 completed all 8 clamps, 2 completed 7 clamps and 1 completed 1 clamp. We present the pharmacokinetic profiles of insulin lispro, 0.15 U/kg delivered by bolus infusion on Days 0, 3, 5 and 7 of infusion set wear. The Figure shows aggregate results from Control and Investigational infusion sets for insulin concentration (mean±SEM) vs. time by day of set wear. Statistically significant decreases from Day 0 to Day 7 were seen for tmax (p≤0.001) , t50% (early) (p<0.002) , t50% (late) (p<0.001) , and Mean Residence Time (p<0.001) . AUC0-300 declined by approximately 20% from Day 0 to Day 7 (p<0.11) . These results confirm and extend previous observations showing significant progressive acceleration of insulin exposure as a function of duration of infusion set wear time.
T.S.Bailey: Advisory Panel; Abbott Diabetes, CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Consultant; LifeScan, Sanofi, Research Support; Abbott Diabetes, Abbott Diagnostics, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Livongo, MannKind Corporation, Medtronic, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita Medical, Senseonics, ViaCyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker's Bureau; Becton, Dickinson and Company, Medtronic, Sanofi. J.R.Kastner: Consultant; Capillary Biomedical, Inc. P.Strange: Other Relationship; Capillary Biomedical, Inc., Stock/Shareholder; Capillary Biomedical, Inc. L.Shi: None. K.A.Oberg: Consultant; Beta Bionics, Inc., Companion Medical, Tandem Diabetes Care, Inc. J.I.Joseph: Advisory Panel; Capillary Biomedical, Inc., Stock/Shareholder; Capillary Biomedical, Inc. P.J.Strasma: Board Member; Capillary Biomedical, Inc., Employee; Capillary Biomedical, Inc., Stock/Shareholder; Capillary Biomedical, Inc. D.B.Muchmore: Consultant; Capillary Biomedical, Inc., Diasome, Zucara Therapeutics, Stock/Shareholder; Capillary Biomedical, Inc., Diasome.
National Institutes of Health (2R44DK110969-02)