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

Prior treatment

• Unstable Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.
• Use of oral or injectable steroids at the time of enrollment or within the last 2 weeks.
• Planned surgery during the study period that results in prolonged disconnection from study devices.

Other illness

• Hemophilia or any other bleeding disorder.
• History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
• History of DKA event in the last 12 months.
• Currently being treated for adrenal insufficiency.
• Currently being treated for a seizure disorder.
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.

Lab values

• 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).

Other

• Hypothyroidism or hyperthyroidism that is not adequately treated.
• Known ongoing adhesive intolerance that is not well managed.
• Participation in another interventional trial at the time of enrollment.
• Participant with a direct supervisor involved in the conduct of the trial.

• 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.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
• Willingness to participate in all study procedures.
• Access to internet at home and willingness to upload data during the study as needed.
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
• Participant is proficient in reading and writing English.