Bolus Priming (BP) based on Artificial Intelligence (AI) learning of meal patterns, added to our established Automated insulin delivery as Adaptive Network (AIDANET) algorithm and running on iPhone Diabetes Assistant (iDiAs) phone wirelessly connected to Tandem Mobi insulin pump and Dexcom Continuous Glucose Monitor (CGM).
A randomized cross-over trial assessing glycemic control on AIDANET equipped with its standard bolus vs AIDANET AI. A secondary comparison of AIDANET AI vs a current commercial Hybrid Closed Loop (HCL) system is planned as well. Following enrollment and screening, participants will be randomized 1:1 to two 8-week sequences: Group A participants will continue to use their home Hybrid closed loop (HCL) system for 2 weeks, then switch to AIDANET for two weeks, and the switch to AIDANET AI for another 4 weeks. Group B participants will begin with 4 weeks of AIDANET AI, then switch to AIDANET for 2 weeks and then revert to their home HCL systems for the last 2 weeks of the study (Figure 1). The last two weeks of the 4-week AIDANET AI session will be used for analysis, comparing standard Ambulatory Glucose Profile (AGP) metrics across AIDANET vs AIDANET AI, with primary outcome Time in Range (TIR) (70-180 mg/dL) during the day. Secondary analyses will compare AIDANET AI 2-week AGP to HCL AGP metrics. Both analyses use randomized crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
During the HCL session, participants will be using their own HCL systems for 2-weeks.
Participant will use the AIDANET algorithm on the Mobi system with the standard Bolus Priming System (BPS) automated bolus that does not require announcement of meals.
Participant will use the AIDANET algorithm with the addition of the Bolus Priming (BP) based on AI learning of meal patterns.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Time in Range (TIR) 70-180 mg/dL for 2-week free-living at home periods on AIDANET vs AIDANET AI.
The last two weeks of the 4-week AIDANET AI session will be used for analysis, comparing standard Ambulatory Glucose Profile metrics across AIDANET vs AIDANET AI, with primary outcome TIR (70-180 mg/dL) during the day.
Time frame: two weeks
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