NCT07070830

Who might be able to join this trial:

• You are between 18 and 75 years old at the time of signing up.
• You have been diagnosed with type 2 diabetes and have been using an insulin regimen (such as basal-bolus, basal only, or pre-mix insulin) for at least 3 months before the screening visit.
• You are currently on a basal-bolus, pre-mix, or basal-only insulin plan and are suitable to switch to an automated insulin delivery (AID) pump; if you use basal-bolus or pre-mix insulin, your HbA1c blood sugar marker must be below 14%, and if you use basal-only insulin, it must be between 7% and 14% (confirm with trial site).
• You are willing to use only specific types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, or their approved generic versions.
• You agree to supply your own insulin for the entire duration of the study.
• Any other diabetes or blood sugar medications you take have been at a stable dose for the past 4 weeks, as confirmed by the study doctor.
• Any weight loss medications you take have been at a stable dose for the past 4 weeks, and you plan to keep them stable throughout the study (unless your doctor reduces or stops them).
• You are willing to wear the study device continuously throughout the whole study period.
• You agree to provide your own compatible smartphone to use with the Dexcom G6 continuous glucose monitor (CGM).
• The study doctor believes you have the ability to understand and operate all the study devices and follow the study rules.
• You are able to read and understand English.
• You are willing and able to sign the consent form agreeing to take part.
• If you are a woman who could become pregnant, you are willing to undergo pregnancy testing as required.

Who may not be able to join:

• You have used an automated insulin delivery (AID) pump in its automated mode within the 90 days before your screening visit.
• You have a medical condition that the study doctor believes would put you at an unacceptable health risk, such as untreated cancer, unstable heart disease, severe or end-stage kidney disease, or an eating disorder such as anorexia or bulimia.
• A recent heart test (ECG within the past 30 days) has shown an irregular heartbeat or other heart condition that the study doctor considers a safety risk.
• You have unstable heart (coronary artery) disease, chest pain that limits moderate exercise even with treatment, or you have had a heart attack, stent procedure, or bypass heart surgery within the past 12 months.
• You have any major surgery planned during the study period, as determined by the study doctor.
• You have had more than one severe low blood sugar (hypoglycemic) episode in the 6 months before screening.
• You have had more than one episode of diabetic ketoacidosis (DKA) or a serious high blood sugar emergency (hyperosmolar hyperglycemic syndrome) in the 6 months before screening, unless it was caused by illness, a pump blockage, or a new diabetes diagnosis.
• You have had a blood disorder in the 3 months before screening that could affect the accuracy of your HbA1c blood test result, as determined by the study doctor.
• You currently take a medication called hydroxyurea.
• You have taken steroid tablets or injections in the 4 weeks before screening, had a local steroid injection (such as into a joint or spine) in the week before screening, or plan to take steroids during the study.
• You are unable to tolerate adhesive tape on your skin, or you have an unresolved skin condition that would make it difficult to place the sensor or pump.
• You are currently pregnant or breastfeeding, planning to become pregnant during the study, or you are a woman of childbearing potential who is not using an acceptable form of contraception (such as abstinence, condoms, oral or injectable contraceptives, an IUD, or an implant).
• You have international travel planned during the study period.
• You have taken part in another clinical study involving an experimental drug or device (other than the Omnipod) in the 30 days before screening, or you plan to do so during this study.
• The study doctor does not believe you will be able to follow