The purpose of this study is to understand the impact of the automated priming boluses on the safety and feasibility of a new fully automated AP controller.
Study participants will be admitted to the hotel for a 4-night study, receiving the two sessions in random order: 1) Fully control loop (FCL) with the bolus priming system (BPS) activated, 2) FCL without the BPS, with a 24-hour washout period in between. During the admission, participants will receive structured meals and have blood glucose control followed to compare time in range 70-180 mg/dL between Controller sessions. After the first 24 hour period on the first FCL approach (BPS vs. no BPS,) that the participant has been randomized to, there will be a 24 hour challenge period before shifting to the other randomized approach; during this session participants will undergo further testing of the control algorithm, including meal challenges and a high-intensity interval training bout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
The automated insulin delivery system includes the Bolus Priming System, a software automatically analyzing past continuous glucose monitoring values to trigger priming insulin bolus delivery isn the suspected presence of meal like glycemic disturbances
The automated insulin delivery system does not include the Bolus Priming System, and therefore does not automatically command priming boluses.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Difference in Daytime Percent Time-in-range
Percentage of CGM values falling between 70 and 180 mg/dL during daytime (6am to midnight)
Time frame: 18 hours
Difference in Overall Percent Time-in-range
Percentage of CGM values falling between 70 and 180 mg/dL
Time frame: 24 hours
Difference in Daytime Percent Time-below-range
Percentage of CGM values falling below 70mg/dL during daytime (6am to midnight)
Time frame: 18 hours
Difference in Overall Percent Time-below-range
Percentage of CGM values falling below 70mg/dL
Time frame: 24 hours
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