INGR1D
Research type
Research Study
Full title
Investigating Genetic Risk for Type 1 Diabetes
IRAS ID
234377
Contact name
Manu Vatish
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
Primary prevention of common chronic disease is a major public health goal. Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. The clinical onset of type 1 diabetes is preceded by a phase where the child is well but has multiple beta-cell auto-antibodies in their blood against insulin-producing beta cells, which are present in the pancreas. Neonates and infants who are at increased risk of developing multiple beta-cell auto-antibodies and type 1 diabetes can now be identified using genetic markers. This provides an opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.
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.
Summary of Results
Between April 2018 and November 2020, over 15500 babies were enrolled into ‘INGR1D’ (Investigating Genetic Risk for T1D), a research study to identify newborns with an increased genetic risk of T1D. This project, performed as part of a T1D primary prevention study (the Primary Oral Insulin Trial, POInT), has helped to pioneer the integration of genetic screening into the NHS Newborn Blood Spot Screening Programme (NBSSP) for consenting mothers, without affecting the screening pathway
From April 2018 to November 2020, 66% of women approached about INGR1D chose to participate, leading to a total of 15 660 babies being enrolled in the study. During this period 14 731 blood samples were processed, of which 157 had confirmed positive results. Of these families 34 declined formal counselling about the positive result, and of the 124 families who undertook this counselling 49 agreed to take part in POInT. It is of note that 20 families were unable to participate in POInT due to lockdown restrictions. 107 (0.68%) of INGR1D’s 15 660 participants were withdrawn from the study. The most common reasons for withdrawal were a technical error with the sampling machine (36 participants), withdrawing consent or issues with consent (32 participants), and being out-of-area at the time the newborn blood spot was taken (27)
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0005
Date of REC Opinion
12 Feb 2018
REC opinion
Further Information Favourable Opinion