A randomized crossover trial assessing glycemic control using Reinforcement Learning trained Bolus Priming System (BPS\_RL) added to the the Automated Insulin Delivery as Adaptive NETwork (AIDANET algorithm) compared to the original AIDANET algorithm.
After receiving training on the study equipment, participants will use the AIDANET system at home for 7 days/6 nights to establish a baseline and initialize the control algorithm. Participants will then be studied at a hotel session for 3 days/2 nights. Participants will transition to home use of AIDANET+ BPS\_RL for 7 days/6 nights.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Group A participants will use the AIDANET system at home for 7 days/6 nights. They will continue use of AIDANET system for 18 hours during the hotel session and then use AIDANET+BPS\_RL for 18 hours during the hotel session.
Group B participant will use the AIDANET+BPS\_RL system for 18 hours during the hotel session and will then use AIDANET system for 18 hours during the hotel session. They will continue to use AIDANET+BPS\_RL system at home for 7 days/6 night and then use the AIDANET system at home for 7 days/6 nights.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
RECRUITINGCGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS_RL.
The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.
Time frame: 36 hours total (18 hours for Group A and 18 hours for Group B)
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