Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated … (NCT07517770) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated Control Algorithm (AIDANET)
United States50 participantsStarted 2026-05-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18.0 years old at time of consent
✓. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes (T1D) for at least one year.
✓. Currently using an automated insulin delivery (AID) system.
✓. 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.
✓. 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 participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
✓. Participant not currently known to be pregnant or breastfeeding.
✓. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
✓. Willingness to use the study AIDANET system (CGM, insulin pump, and phone) during the study period.
Exclusion criteria
✕. Plans to start a new non-insulin glucose-lowering agent (e.g., Glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
What they're measuring
1
Time in Range (TIR) 70-180 mg/dL for 2-week free-living at home periods on AIDANET vs AIDANET AI.