Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated Control Algorithm (AIDANET)
Sue Brown
Summary
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).
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes (T1D) for at least one year. 3. Currently using an automated insulin delivery (AID) system. 4. Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team. 5. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either live with pa…
Interventions
- DeviceHybrid Closed Loop (HCL) x 2 weeks
During the HCL session, participants will be using their own HCL systems for 2-weeks.
- DeviceAIDANET x 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.
- DeviceAIDANET AI x 4 weeks
Participant will use the AIDANET algorithm with the addition of the Bolus Priming (BP) based on AI learning of meal patterns.
Location
- University of Virginia Center for Diabetes TechnologyCharlottesville, Virginia