Investigating Genetic Risk for Type 1 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autoimmune Diseases
- Diabetes Mellitus
- Diabetes Mellitus - Type 1
- Endocrine System Diseases
- Glucose Metabolism Disorders
- Immune System Diseases
- Metabolic Disease
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Younger than 4 years
- Gender
- Both males and females
Description
This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newbor...
This is a population screening study to undertake (with prospective consent) additional testing of the newborn screening blood to identify children at increased genetic risk of type 1 diabetes. This study will enrol newborn babies whose mothers have given consent to additional testing for the newborn blood screening (routinely performed when the baby is approximately 5 days old). Women will be approached by research staff in the second or third trimester of pregnancy (?18 weeks gestation) when attending for antenatal care. At this point, the study will be discussed with the woman and if interested a patient information sheet will be provided as well as the opportunity to ask questions. If they agree to participate, a qualified member of the research team will take written informed consent. This consent will allow a) completion of a questionnaire and b) prospective consent to use the surplus neonatal screening blood sample for genetic testing. The punch from the blood sample will analysed for the child's risk of type 1 diabetes. If found to be at high risk (>10%) they will be contacted by a member of the clinical study team to discuss the results and invite them to participate in a phase II prevention trial.
Tracking Information
- NCT #
- NCT03503747
- Collaborators
- Not Provided
- Investigators
- Not Provided