Type 1 Diabetes Trial, Recruiting

Written by an AI model from the 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 who have been diagnosed with type 1 diabetes for at least 1 year.
• Adults aged 18 or older (any gender).
• People whose average blood sugar level (measured by HbA1c or a sensor-based estimate called GMI) is 7.0% or higher at the screening appointment.
• People who are physically able to do 30 minutes of exercise, as assessed by the trial investigator.
• People who have been using an FDA-approved hybrid closed loop insulin system (an automated insulin delivery device) for at least 3 months.
• People who live with another adult (aged 18 or older) who sleeps in the home at night and is willing to attend training on using the study system.
• People who live within 40 miles of OHSU (Oregon Health & Science University).
• People whose total daily insulin use is less than 139 units per day.
• People who can read, write, and understand spoken English.
• People who currently own and use a smartphone so study staff can contact them.
• People who are willing to follow all study procedures and attend all clinic visits.
• People who are willing to sign the informed consent and privacy (HIPAA) documents.

Who may not be able to join:

• People whose average blood sugar level (GMI or HbA1c) is below 6.5% or above 10.5%.
• People whose continuous glucose sensor data shows that blood sugar was above 250 mg/dl less than 2% of the time over the past 30 days.
• People who are pregnant, planning to become pregnant, or breastfeeding, or who are not using an accepted form of contraception (such as the pill, patch, vaginal ring, Depo-Provera, Norplant, an IUD, a double barrier method, or abstinence).
• People with any significant heart or cardiovascular condition, including a history of stroke, heart failure, heart attack, angina, bypass surgery, or angioplasty, or a significant abnormal heart reading (EKG) at screening.
• People with significantly reduced kidney function (confirm with trial site for specific test values).
• People with liver failure, cirrhosis, or any other liver disease that affects how the liver works, as determined by the investigator.
• People who have had a severe low blood sugar episode in the past 6 months, or who have difficulty sensing when their blood sugar is low, as assessed by the investigator and a questionnaire.
• People who have been admitted to hospital for diabetic ketoacidosis (a serious diabetes complication) in the past 6 months.
• People with adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones).
• People with any active infection, such as a skin infection requiring antibiotics.
• People with known or suspected misuse of alcohol, narcotics, or illegal drugs.
• People with a seizure disorder.
• People with an active foot ulcer (an open sore on the foot).
• People with peripheral arterial disease (reduced blood flow to the limbs).
• People who have had major surgery within the 30 days before screening.
• People who have used an experimental drug within the 30 days before screening.
• People who regularly take immune-suppressing medications (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
• People with a bleeding disorder or a very low platelet count (below 50,000).
• People with a known allergy to Fiasp insulin.
• People currently taking oral or injected corticosteroids (a type of steroid medication).
• People with any life-threatening illness, or a history of cancer in the past 5 years (except certain minor skin cancers).
• People currently taking beta blockers or a specific type of blood pressure medication called non-dihydropyridine calcium channel blockers.
• People currently taking any medication that lowers blood sugar other than insulin — with the exception of metformin, if the dose has been stable for 3 or more months and the person is willing to keep the dose unchanged during the study.
• People with gastroparesis (a condition where the stomach empties too slowly).
• People whose daily diet includes fewer than 50 grams of carbohydrates per day.
• People who answer "yes" to certain questions on a standard physical activity readiness questionnaire — with one exception: people who take a single blood pressure medication that does not affect heart rate, and whose blood pressure is well controlled, may still be considered (confirm with trial site).
• People who experience any chest pain, pressure, or discomfort during physical activity.
• People with any other significant illness or condition that the investigator believes could put them at risk or affect their ability to follow the study procedures.

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