Early Phase 1 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 40 years old (inclusive).
• You have been diagnosed with stage 2 or stage 3 type 1 diabetes, based on the American Diabetes Association's 2024 guidelines.
• At least one specific diabetes-related antibody was found in your blood at screening (such as GADA, IA-2A, IAA, ZnT8A, or ICA); people with two or more of these antibodies will be given priority for enrollment (note: the insulin antibody test only applies if you have been on insulin for two weeks or less).
• A specific test (a mixed-meal tolerance test or a fasting blood test) shows that your pancreas is still producing a certain minimum level of a hormone called C-peptide, which indicates some remaining insulin-producing function.
• You, or your legal representative, are willing and able to give written consent to take part in the study.

Who may not be able to join:

• You have a type of diabetes other than type 1, such as gestational diabetes, a genetic form of diabetes, or diabetes caused by another medical condition or injury.
• Your blood test at screening shows abnormal blood counts, such as low red blood cells (anaemia), low white blood cells, low neutrophils (a type of infection-fighting cell), or low platelets.
• Your blood tests at screening show signs of liver damage above a certain level.
• You have a serious heart condition, such as angina, a history of heart attack, heart failure, or a significant irregular heartbeat.
• You have significant kidney disease, including poor kidney function below a certain level, or you are receiving (or expected to need) kidney replacement therapy such as dialysis.
• You are currently taking medications that the trial doctor believes could meaningfully affect the course of your type 1 diabetes or your immune system.
• You have uncontrolled diabetic ketoacidosis (a serious diabetes complication where dangerous acids build up in the blood).
• You have an uncontrolled infection at screening, or your blood tests are positive for certain infections including hepatitis B (under specific conditions), hepatitis C, HIV, syphilis, or Epstein-Barr virus above a certain level.
• You have another active autoimmune disease (besides type 1 diabetes) that requires treatment affecting the whole immune system, or that has caused damage to any organ.
• You are pregnant, breastfeeding, planning to become pregnant within one year, or are unwilling to use effective contraception during the study (if pregnancy is possible for you).
• You have a history of cancer, unless the trial doctor considers it fully cured with no risk of it returning.
• You have taken part in another clinical trial within the last 3 months before enrolling.
• You have received a live attenuated vaccine (a type of vaccine using a weakened live virus or bacteria) within the past 4 weeks, or you plan to receive one during the study.
• The trial doctor has any other reason to believe the study would not be appropriate for you (confirm with trial site).

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