[米国FDAが承認またはクリアしていないデバイスの臨床試験] (INSIGHT)

Participant Inclusion Criteria

1. Age ≥18.0 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
3. Having used an FDA approved AID system within the last 6 months (can be intermittent use).
4. Currently using insulin for >6 months.
5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
7. Participant not currently known to be pregnant or breastfeeding.
8. 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 participants 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.
9. Willingness to wear a Dexcom CGM during each of the study phases.
10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
11. Willingness not to start any new non-insulin glucose-lowering agent during the trial.
12. Willingness to participate in all study procedures including in person training.
13. Access to internet at home and willingness to upload data during the study as needed.
14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.
15. Participant is proficient in reading and verbal communication in English.

Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.

1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
2. Current use of sulfonylurea medications.
3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
4. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
5. Hemophilia or any other bleeding disorder.
6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
7. History of DKA event in the last 12 months.
8. Currently on peritoneal or hemodialysis.
9. Currently being treated for adrenal insufficiency.
10. Currently being treated for a seizure disorder.
11. Hypothyroidism or hyperthyroidism that is not adequately treated.
12. Use of oral or injectable steroids at the time of enrollment.
13. Known ongoing adhesive intolerance that is not well managed.
14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
15. Participation in another interventional trial at the time of enrollment.
16. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.