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:

• People aged 18 to 68 years, of any gender.
• People who are able to give written consent and follow the study's procedures.
• People with a clinical history consistent with Type 1 diabetes that was diagnosed before age 40, who have been on insulin for more than 5 years, and where their age plus the number of years on insulin adds up to more than 28.
• People whose pancreas produces little to no insulin on its own, shown by a specific test (called a mixed meal tolerance test) where a certain protein marker in the blood stays below a very low level.
• People who either had a kidney transplant at least 3 months ago and are on a specific type of anti-rejection medication regimen, or who will receive an islet transplant within 72 hours of receiving a kidney transplant from the same donor.
• People whose kidney function has been stable, based on recent blood test results showing no significant change in kidney filtering levels over the past 3 months.

Who may not be able to join:

• People who weigh more than 90 kg or have a BMI over 30.
• People whose daily insulin needs are either too high (more than 1.0 units per kg of body weight per day) or too low (less than 15 units per day).
• People who have had a transplant of an organ other than a kidney, with a specific exception for those who had a pancreas transplant that failed within the first two weeks due to a blood clot, followed by removal of the pancreas, where that pancreas transplant happened more than 6 months before joining the study.
• People with untreated or unstable damage to the blood vessels in the eyes related to diabetes.
• People with blood pressure that remains too high (above 160/100 mmHg) even with medication.
• People whose kidneys are not filtering blood well enough, based on a specific calculation using blood test results (confirm with trial site for exact threshold, as it differs slightly for people who follow a fully plant-based diet).
• People who have developed a significant new level of protein in their urine since their kidney transplant.
• People with high levels of certain immune antibodies (anti-HLA antibodies above 50% for either class) combined with other specific immune compatibility concerns detected through laboratory testing.
• Women who are pregnant, breastfeeding, who want to become pregnant at any point during or after the study, or who are unwilling to use effective contraception during the study and for 4 months afterwards. Men who plan to father a child during the study or within 4 months after finishing, or who are unwilling to use effective contraception (note: condoms used alone are not considered acceptable in this study).
• People with a current or past active infection, including hepatitis B, hepatitis C, HIV, or tuberculosis — including cases where lab results show infection even if there are no obvious symptoms.

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