Investigating Genetic Risk for Type 1 Diabetes (INGR1D)

University of Oxford

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Diabetes Mellitus; Immune System Diseases; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT03503747

OVG 2017/09

Details and patient eligibility

About

The objective of this study is to determine the percentage of children with genetic markers putting them at increased risk of developing type 1 diabetes, and to offer the opportunity for these children to be enrolled into a phase II b primary prevention trial.

Full 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 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.

Enrollment: 15,640 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parent/guardian of participant is willing and able to give informed consent for participation in the study.
• Participant has provided blood for the newborn screening blood test, with sufficient sample remaining after routine testing.

Exclusion criteria

• Parent/legal guardian unwilling or unable to give written informed consent to participate in the study
• Unable to understand written or verbal English which would preclude them from understanding the study