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SAFETY AND EFFECTIVENESS OF AN INVESTIGATIONAL INSULIN DELIVERY DEVICE DELIVERING BASAL/BOLUS THERAPY WITH EITHER RAPID-ACTING OR REGULAR HUMAN INSULIN IN PATIENTS WITH TYPE 2 DIABETES

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Abstract

Background and Aims: This study assessed usability, 24-hour glycemic profiles, and safety of an investigational basal/bolus Insulin Delivery Device (IDD) in patients with type 2 Diabetes (T2D) transitioning from multiple daily injection (MDI) therapy. Method: Patients with T2D using MDI insulin therapy with HbA1c 7-11% were enrolled in this single center, exploratory, open-label, 2-phase study. During a 9-day in-clinic period, patients continued their usual MDI therapy during Phase 1 (3 days) and then switched to the IDD for Phase 2 (6 days), based on their usual doses. Patients wore blinded CGM devices throughout. Results: 21 patients were enrolled (mean±SD; age = 57±8 years; HbA1c = 8.2±0.9%), using rapid acting (U-100 Humalog) (n=11) or Regular human insulin (U-100 Humulin R) (n=10). Comparing MDI to IDD phases, there was a significant reduction in FBG (141.2±38.3 mg/dL vs. 121.2±35.0 mg/dL, p=0.002), improved 24 hour mean blood glucose (137.0±20.5 mg/dL vs.125.0±16.5 mg/dL, p=0.004) and improved time-in-range (70-180 mg/dL) (81.0±14.4% vs. 87.5±10.6%, p=0.008), respectively. There were no significant differences for time <70 mg/dL (1.6±2.7% vs. 3.1±2.7%, p =0.08), CV% or mean of daily differences (MODD) between MDI and IDD. Mean amplitude of glycemic excursions (MAGE) was significantly lower with IDD vs. MDI (p=0.011). There were no serious adverse events. *Disclaimer: Regular human insulin is not approved for use in pumps. Conclusions: This brief, exploratory study of an investigational IDD showed that it was safe and effective in patients with MDI-treated T2DM using either Humalog or Humulin R.

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© Copyright 2019 Morressier GmbH.
All rights reserved.