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

Inclusion criteria

• . Age ≥18.0 years old at time of consent
• . Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
• . Having used an AID system equipped with Dexcom G6 or G7 CGM within the last three months (does not need to be continuous use if CGM was unavailable for instance).
• . Currently using insulin for at least six months.
• . 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 lives 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 capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). 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.

Exclusion criteria