Type 1 Diabetes Clinical Trial
Official title:
A Randomized Study to Compare a Fully-closed MPC Control Algorithm With a Commercial Hybrid Closed-loop Algorithm
An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. If a meal is detected that was not reported by the user, the system shall calculate the amount of meal insulin that will be dosed and deliver that insulin. The investigators will test how well the new algorithm manages glucose compared to the participant's usual care including the tslim X2 pump with Control IQ enabled. This type of algorithm may improve glucose control for high risk patient populations.
Participants will undergo one 7-day Intervention Period and one 7-day Control Period in randomized order. During the 7-day intervention, participants will wear an Omnipod to deliver Fiasp insulin and a Dexcom G6 CGM. The CGM system will provide sensed glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat one meal in clinic and complete system training on Day 1 and then spend the rest of the 7 days at home. During the 7-day control, the participant will continue their usual diabetes care regimen using the tslim X2 pump with Dexcom G6 with Control IQ enabled. ;
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