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Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes
This is a single-center randomized crossover trial. The investigators will target completion of 15 adults (age 18-65 years) with Type 1 Diabetes who use an insulin pump. After completion of the Screening Visit, each subject will participate in a 28-day at home Data Collection Period while using their personal insulin pump, a personal glucometer, a study CGM, and a study activity tracker (i.e., Fitbit). This data collection period may be extended to obtain to gather more days of quality data, if needed per principal investigator judgement. Once the data has been collected and processed, subjects will participate in two 24-hour admissions (Experimental and Control Admission) in a semi-controlled environment (i.e., hotel), performed in the assigned random order. During both admissions, subjects will use the personal insulin pump and glucometer, and a study CGM. The exercise session will consist of three 15-minute bouts of moderate-intensity exercise (i.e., stationary bicycle). Subjects will be provided a controlled dinner; the SI-informed bolus calculator will be used in the Experimental Admission while standard therapy will be used in the Control Admission. Subjects will then be observed overnight and discharged in the following morning.
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