Clinical Trials | InsuLearn Clinical Trial
Feasibility of a bolus calculator without carbohydrate counting in T1D patients under MDI therapy: A supervised randomized controlled trial
The University of Virginia, Department of Diabetes Technology, seeks adults 18 years and older who use multiple daily injections (MDI) to manage their Type 1 Diabetes to participate in a clinical study. The purpose of this study is to improve blood glucose levels after eating meals even when you are not able to exactly measure the carbohydrates in the meal. This study will test an investigational algorithm (complex mathematical formula) called InsuLearn through a smart insulin pen. The pen will recommend the amount of insulin to bolus with your meal and estimate the carbohydrates. We are looking for participants using multiple daily injections (MDI) treatment and having difficulties with counting carbohydrates. You may be eligible for this study if: You were diagnosed with type 1 diabetes at least one year ago. You are using MDI treatment for the last six months. You are willing to wear a continuous glucose monitor (CGM) during the study. You are willing to use the insulin smart pen app to record and deliver your insulin doses. You are willing to participate in a 51-hour hotel admission. The study involves: -8 study visits during the 6-week study; all visits except for the hotel admission may be completed remotely. -Wearing a CGM to measure your blood glucose levels. -Use a smart insulin pen to deliver your insulin, help calculate insulin doses and estimate your carbohydrates for meals. -Staying at a hotel to test the study algorithm. The following study-related tests and supplies are provided free of charge: -Hemoglobin A1c Test (fingerstick) -CGM supplies -Smart Insulin Pen -Glucometer supplies