Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes

Eligibility Criteria

• 1. Age ≥18.0 years old at time of consent.
• 2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
• 3. HbA1c ≥ 7.5%.
• 4. Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)
• 5. Willingness to discontinue a personal CGM during the duration of the study.
• 6. Access to the internet and willingness to upload data during the study as needed.
• 7. If female and sexually active, 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.
• 8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, Glucagon-like peptide (GLP)-1 receptor agonists, pramlintide, Dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas and nutraceuticals).
• 1. Treatment with meglitinides/sulfonylureas.
• 2. Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).
• 3. Currently being treated for a seizure disorder.
• 4. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples: a) Inpatient psychiatric treatment in the past 6 months, b) Presence of a known adrenal disorder, c) Uncontrolled thyroid disease.
• 5. Currently pregnant or intent to become pregnant during the trial.
• 6. Currently breastfeeding.