Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated Control Algorithm (AIDANET)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSue Brown

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Current use of an sodium-glucose transport protein 2 (SGLT-2) or SGLT-1/2 inhibitor due to risk of euglycemic diabetic ketoacidosis (DKA).

Hemophilia or any other bleeding disorder.

History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.

Trial design

Treatments tested in this trial

  • Hybrid Closed Loop (HCL) x 2 weeks
  • AIDANET x 2 weeks
  • AIDANET AI x 4 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sue Brown

Lead sponsor

University of Virginia

Sponsor institution

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Tandem Diabetes Care, Inc.

Collaborator