Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm

Inclusion Criteria:

1. Age ≥18.0 years old at time of consent

2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for atleast one year.

3. Having used an AID system equipped with Dexcom G6 or G7 CGM within the last threemonths (does not need to be continuous use if CGM was unavailable for instance).

4. Currently using insulin for at least six months.

5. Willingness to switch to use a commercially approved personal insulin (e.g., lisproor aspart, or biosimilar approved products) within the study pump as directed by thestudy team.

6. Has one or more supportive companions knowledgeable about emergency procedures forsevere hypoglycemia and able to contact emergency services and study staff thateither lives with participant or located within approximately 30 minutes ofparticipant and able to locate participant in the event of an emergency.

7. Participant not currently known to be pregnant or breastfeeding.

8. If participant capable of becoming pregnant, must agree to use a form ofcontraception to prevent pregnancy while a participant in the study (e.g. hormonalcontraception, abstinence from heterosexual intercourse). A negative serum or urinepregnancy 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 becomepregnant within the timespan of the study will be discontinued.

9. Willingness to use the study AIDANET system (CGM, pump, and phone) during the studyperiod.

10. Willingness not to start any new non-insulin glucose-lowering agent during thecourse of the trial.

11. Willingness to participate in all study procedures including the house/hotelsessions.

12. Access to internet at home and willingness to upload data during the study asneeded.

13. Investigator has confidence that the participant can successfully operate all studydevices and is capable of adhering to the protocol.

14. Participant is proficient in reading and writing English.

Exclusion Criteria:

1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptoragonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stabledose of such an agent for at least the past month.

2. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.

3. Hemophilia or any other bleeding disorder.

4. History of severe hypoglycemic events with seizure or loss of consciousness in thelast 12 months.

5. History of DKA event in the last 12 months.

6. Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.

7. Currently being treated for adrenal insufficiency.

8. Currently being treated for a seizure disorder.

9. Hypothyroidism or hyperthyroidism that is not adequately treated.

10. Use of oral or injectable steroids at the time of enrollment or within the last 4weeks.

11. Planned surgery during the study period.

12. Known ongoing adhesive intolerance that is not well managed.

13. A condition, which in the opinion of the investigator or designee, would put theparticipant or study at risk.

14. Participation in another interventional trial at the time of enrollment.

15. Participant with a direct supervisor involved in the conduct of the trial.