1069-P: Safety and Efficacy of a Novel Basal-Bolus Insulin Delivery Device (IDD) in Adults with T2D Using Rapid-Acting or Regular Human Insulin

Abstract

Objective: To assess usability, 24-hour glycemic profiles, and safety of an investigational basal/bolus IDD in people with T2D transitioning from MDI. Research Design and Methods: This single-center, open-label, two-period pilot study enrolled people with T2D and HbA1c 7-11%. Subjects continued their usual MDI therapy during a 2-3 -day in-clinic MDI period and then were switched to the IDD for a 6-day in-clinic IDD period, without changing insulin dose. Subjects wore blinded CGM throughout each in-clinic period. Results: Twenty-one people (mean±SD age 57±8 years; HbA1c 8.2±0.9%) using U-100 insulin lispro (n=11) or U-100 regular human insulin RHI (n=10) were enrolled. Glycemic measures improved from the MDI to the IDD period, including FBG: 141.2 ± 38.3 mg/dl vs. 121.2 ± 35.0 mg/dl (P=0.002), respectively; 24-hour mean glucose: 137.0 ± 20.5 mg/dl vs.125.0 ± 16.5 mg/dl (P=0.004), and time-in-range (70-180 mg/dL): 81.0 ± 14.4% vs. 87.5 ± 10.6% (P=0.008). There were no significant differences between MDI and IDD for time in hypoglycemia (<70 mg/dL), CV%, nor mean of daily differences (MODD). Mean amplitude of glycemic excursions (MAGE) was significantly lower with IDD (P=0.011). There were no serious AEs. There were no significant differences between insulin lispro and RHI for any glycemic measures, within either phase. *Disclaimer: RHI is not approved for use in pumps. IDD not available for sale. Conclusions: Results of this pilot study suggest that the IDD, used with insulin lispro or RHI, is as safe and effective for adults previously prescribed MDI therapy, without requiring dose change, in the short term. Administering either insulin lispro or RHI in the IDD led to similar glycemic responses and outcomes based on 24-hour glycemic profiles in people with T2D. To our knowledge, this is the first study to evaluate RHI in people with T2D using CGM for 24-hour glycemic profiles. Additional trials are warranted to further evaluate this novel IDD in larger populations. Disclosure R. Aronson: Research Support; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Senseonics. E.T. Mahoney: Employee; Self; Becton, Dickinson and Company. D. Saliu: Employee; Spouse/Partner; Allergan. Employee; Self; Becton, Dickinson and Company. L. Bergquist: Employee; Self; Becton, Dickinson and Company. L. Hirsch: Employee; Self; Becton, Dickinson and Company. Stock/Shareholder; Self; Merck & Co., Inc.