Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM

"The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump or MDI. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements:~1. An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data~2. An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment.~3. A smart bolus calculator based on CGM glucose measurements and insulin sensitivity estimation."

During the Control study admission, DiAs will be programmed with the home insulin dosing parameters. The study subject will use the home basal/bolus MDI or continuous subcutaneous insulin infusion (CSII) insulin regimen via the home insulin pens or pump and determine the amount of insulin to give for the entire admission per the subject's home carb counting parameters and as calculated by the DiAs meal screen.