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.

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.