Phase 2 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:

• You are between 18 and 68 years old
• You have been diagnosed with Type 1 diabetes for at least 5 years, confirmed by a specific blood test showing very low insulin production (confirm with trial site)
• Your blood sugar levels are unstable, meaning you experience low blood sugar (below 54 mg/dl) more than once a week, and/or you cannot feel when your blood sugar drops dangerously low, and/or you had one or more severe low blood sugar episodes in the past 12 months, and/or unpredictable blood sugar levels that disrupt your daily life, and/or one or more hospital visits for diabetic ketoacidosis in the past 12 months
• You are willing and able to follow all requirements after the procedure, including taking anti-rejection medicines, using reliable birth control, attending frequent clinic visits, keeping detailed records of blood sugar levels, insulin doses, and medications
• You are able to give your informed consent to participate
• You are fully vaccinated against COVID-19

Who may not be able to join:

• Your BMI is above 33
• Your daily insulin needs are more than 1.0 units per kilogram of body weight
• You have significant kidney problems, shown by certain blood or urine test results (confirm with trial site)
• You have significant liver or gallbladder disease, including abnormal liver enzyme levels, abnormal bilirubin, low albumin, liver growths, blocked liver veins, signs of liver pressure problems, or untreated gallstones
• You have significant heart or blood vessel disease, including certain heart problems with reduced heart pumping function, a heart attack in the last 12 months, or severe circulation problems in the limbs that cannot be fixed with surgery
• You have active, worsening damage to the blood vessels in your eyes related to diabetes
• You have high blood pressure of 140/90 or above, even with treatment
• You have high cholesterol or high triglyceride (fat) levels in your blood that remain too high despite treatment (confirm with trial site for specific numbers)
• You have anemia (low red blood cell levels) or other blood disorders that need medical treatment
• Your white blood cell count is too low (confirm with trial site)
• You have a higher-than-normal risk of bleeding, a clotting disorder, or you take blood-thinning medicines such as heparin or warfarin
• You currently have an unresolved infection (other than a mild skin or nail fungal infection), or a long-term infection such as tuberculosis, HIV, hepatitis B or C, CMV, or syphilis
• A specific blood test shows you have never been exposed to the Epstein-Barr virus (EBV) (confirm with trial site)
• You have a history of any cancer, except for certain fully removed skin cancers or cervical in-situ cancer
• You have active peptic ulcer disease (stomach ulcers)
• You have had gastric bypass surgery
• You have recently not followed recommended medical treatment
• You have an untreated psychiatric illness, or one that is likely to seriously affect your ability to follow the study requirements
• You have previously received an organ or tissue transplant
• You have received a live vaccine within the 60 days before joining the study
• You have a long-term condition that requires medicines that are not allowed in this trial (confirm with trial site)
• You have used experimental treatments or drugs within four weeks before joining the study
• You currently misuse alcohol or substances, or smoke cigarettes (you must have stopped for more than 3 months)
• You are pregnant, planning to become pregnant, breastfeeding, or unwilling or unable to use effective birth control throughout the study and for as long as you take anti-rejection medication
• You do not have health insurance that will cover the cost of anti-rejection medicines and follow-up care after the study ends
• You have any other medical condition that the study doctor believes would make it unsafe for you to participate

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