Phase 4 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older.
• People who have been clinically diagnosed with type 1 diabetes for at least one year, based on the treating doctor's judgment (no specific blood tests to confirm the diagnosis are required for this purpose).
• People who have been using a commercial automated insulin delivery (AID) system for at least 3 months.
• People whose blood sugar levels have been in the target range (3.9 to 10.0 mmol/L) less than 70% of the time over the past 30 days, while spending at least 70% of that time in the system's automatic (closed-loop) mode.
• People of childbearing potential who agree to use a highly effective form of birth control and actively avoid pregnancy for the duration of the trial. Childbearing potential applies to people born female who have had their first period, have not yet reached menopause, and do not have a known medical condition that causes infertility (such as a hysterectomy). Menopause is defined as having had no period for 12 months without any other explanation.

Who may not be able to join:

• People who are currently taking, or have taken within the last 2 weeks, any blood sugar-lowering medication other than insulin (for example, SGLT2 inhibitors).
• People who are currently taking, or have taken within the last month, a medication from the GLP-1 receptor agonist class (a type of diabetes medication given by injection or tablet).
• People who are currently taking, or have taken within the last month, high doses of steroid medications (glucocorticoids) taken by mouth or through a drip.
• People who are following, or planning to follow, a very low carbohydrate diet (less than 50 grams of carbohydrates per day).
• People whose kidneys are not functioning well enough, based on a specific kidney function measure (eGFR below 30 mL/min/1.73 m²), tested within the last 12 months.
• People who are currently using a medication called hydroxyurea.
• People who are pregnant or planning to become pregnant.
• People who are currently breastfeeding.
• People who, in the treating doctor's judgment, have an ongoing risk of recurring urinary or genital infections.
• People who have had a severe low blood sugar episode within the month before screening — defined as one that caused a seizure, loss of consciousness, or a visit to the emergency department.
• People who have had a serious diabetes-related complication called diabetic ketoacidosis (DKA) within the 6 months before screening — defined as an episode that required medical attention and treatment with insulin through a drip.
• People with any serious health condition that, in the investigators' judgment, is likely to interfere with completing the trial.
• People with a significant eye complication related to diabetes, as judged by the investigator.
• People who have had a major heart or blood vessel event (such as a heart attack or heart surgery) within the last 3 months.
• People who have previously had a serious reaction to an SGLT2 inhibitor medication.
• People who have used the Medtronic 670G or 770G insulin pump system in the last 30 days.
• People who, in the investigators' opinion, are unlikely to be able to follow the trial's safety requirements or research instructions (such as adjusting pump settings or measuring ketones as directed).

Important: Always verify eligibility with the trial site directly before applying.