Safety and Effectiveness of an Investigational Insulin Delivery Device Providing Basal/Bolus Therapy with Rapid-Acting or Regular Human Insulin in Adults with Type 2 Diabetes

• Published in: Diabetes technology & therapeutics Vol. 22; no. 5; p. 352
• Main Authors: Aronson, Ronnie, Mahoney, Edward, Saliu, Drilon, Sze, David, Morel, Didier, Bergquist, Leya, Hirsch, Laurence
• Format: Journal Article
• Language: English
• Published: United States 01.05.2020
• Subjects: Glycemic control; Type 2 diabetes; Insulin delivery device; Prospective study
• ISSN: 1557-8593
• DOI: 10.1089/dia.2019.0356

This study undertook to assess usability, 24-h glycemic profiles, and safety of an investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI) for people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDIs). This prospective, single-center, open-label two-period study enrolled adults with T2D and glycated hemoglobin (HbA1c) 7%-11% (53-97 mmol/M). Participants continued the usual MDI therapy during a 2- to 3-day in-clinic MDI period and then within 7 days were switched to the IDD, using current insulin dose, for a 6-day in-clinic IDD period, with blinded continuous glucose monitoring throughout the in-clinic periods. We enrolled 21 participants (mean ± standard deviation age 57 ± 8 years; HbA1c 8.2% ± 0.9% [66 ± 9.8 mmol/M]) using U-100 insulin lispro (  = 11) or who switched to U-100 RHI (  = 10). Glycemic measures improved from the MDI to IDD period, including fasting blood glucose (BG), 141.2 ± 38.3 mg/dL (7.8 ± 2.1 mmol/L) versus 121.2 ± 35.0 mg/dL (6.7 ± 1.9 mmol/L;  = 0.002), respectively; 24-h mean BG, 137.0 ± 20.5 mg/dL (7.6 ± 1.1 mmol/L) versus 125.0 ± 16.5 mg/dL (6.9 ± 0.9 mmol/L;  = 0.004); and time in range (at 70-180 mg/dL; 3.9-10 mmol/L), 81.0% ± 14.4% versus 87.5% ± 10.6% (  = 0.008). No significant differences between MDIs and IDD use were recorded for time <70 mg/dL (1.6% ± 2.7% vs. 3.1% ± 2.7%,  = 0.08), CV%, or mean of daily differences. Mean amplitude of glycemic excursions was significantly lower with the IDD (  = 0.011). There were no significant differences between insulin lispro and RHI for any glycemic measure. No serious adverse events were recorded. In the context of this exploratory study, the IDD was safe and effective to administer insulin lispro and RHI for adults with T2D.