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:

Study 1 – Early-onset Type 1 Diabetes group (EET1D):

• People aged 0 to 70 years who have been clinically diagnosed with diabetes within the last 24 months, with evidence meeting standard diabetes diagnostic guidelines
• People whose genetic test results rule out a non-immune-related cause of diabetes (required if diagnosed before 12 months of age)
• People whose genetic risk score for Type 1 diabetes is above the 50th percentile of a Type 1 diabetes reference group, or who have a confirmed genetic form of Type 1 diabetes

Study 1 – Type 1 Diabetes Control group:

• People aged 0 to 70 years with a clinical diagnosis of Type 1 diabetes made between ages 1 and 20, who have been treated with insulin from the time of diagnosis

Study 1 – Monogenic/Neonatal Diabetes (NDM) Control group:

• People diagnosed with diabetes before 12 months of age, where the diagnosis of monogenic or neonatal diabetes has been confirmed by the Exeter Molecular Genetics Laboratory

Study 2 – Early-onset Type 1 Diabetes group (EET1D):

• People aged 0 to 24 months at the time of joining the study, diagnosed with diabetes within the last 24 months, with evidence meeting standard diabetes diagnostic guidelines
• People whose genetic test rules out a non-immune-related cause of neonatal diabetes, and whose genetic risk score or confirmed diagnosis supports Type 1 diabetes

Study 2 – Monogenic/NDM Control group:

• People aged 0 to 18 months at recruitment, diagnosed with diabetes before 24 months of age, with a confirmed diagnosis of monogenic or neonatal diabetes from the Exeter Molecular Genetics Laboratory

Study 2 – Non-diabetic Control group:

• Children aged 0 to 6 years who are attending a participating hospital for a planned (elective) surgical procedure, such as hernia repair, tonsil removal, eye surgery, or MRI under general anaesthetic (this list is not exhaustive — confirm with trial site)

Who may not be able to join:

Study 1:

• People older than 70 years
• People who do not have a diagnosis of diabetes
• People whose diabetes is caused by certain specific genetic mutations (such as HNF1A, HNF4A, HNF1B, or GCK), or who have Type 2 diabetes, or diabetes linked to pancreatic insufficiency or a syndrome
• People who are unwell with another illness at the time blood samples are being taken

Study 2:

• People older than 24 months at the time of recruitment
• People diagnosed with diabetes more than 24 months ago
• People who are unwell with another illness at the time blood or tissue samples are being taken

Non-diabetic Controls:

• Children older than 6 years
• Children who have a diagnosis of diabetes or any other autoimmune condition
• Children with a known disorder of the immune system
• Children currently taking medication that suppresses the immune system
• Children with an ongoing infection or sepsis
• Children with a major birth defect or significant ongoing illness that may affect the immune system (for example, a metabolic disease or 22q deletion syndrome)
• Children who have had a fever-related illness within the past two weeks
• Children with kidney failure

For all participants having blood samples taken (PBMC and RNA sampling):

• People who use recreational drugs (cannabis use more than one week before blood sampling may be acceptable — confirm with trial site)
• People with illness related to heavy alcohol use
• People with kidney failure, indicated by a creatinine level above 200 (confirm with trial site)
• People with any other medical condition that the study investigator considers would affect their safety in the trial

The following factors may lead to a rescheduled visit, or in some cases exclusion, at the investigator's discretion:

• People who are pregnant or breastfeeding
• People who have had a fever-related illness within the past two weeks, or any non-fever illness within the past two to three days
• People currently taking steroids or other immune-suppressing medications
• People who have received immunoglobulin treatments or blood products within the past three months

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