The University of Oxford and the NHS are inviting pregnant women to participate in the world’s first clinical trial to prevent type 1 diabetes in babies and infants.
The trial, which is being supported by the National Institute for Health Research, will investigate whether a small dose of oral insulin can prevent type 1 diabetes in at-risk children.
Pregnant women attending the maternity clinics in Berkshire, Buckinghamshire, Milton Keynes and Oxfordshire are the first for being asked to take part in the INvestigating Genetic Risk for type 1 Diabetes (INGR1D) study, which aims to determine the number of children with a greater than 10% (high) risk of developing type 1 diabetes, based on risk scores derived from single nucleotide polymorphisms (SNPs) that show the presence of HLA DR3, HLA DR4 and HLA DQ8 alleles as well as SNPs from HLA class I and non-HLA type 1 diabetes susceptibility genes, and from HLA class II protective alleles.
At-risk infants will then be offered the opportunity to participate in the phase 2b placebo-controlled Primary Oral Insulin Trial (POInT). POInT is a randomised, double-blind primary prevention phase 2b study being conducted as part of the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD). The aim of the study is to induce immune tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. The study objective is to determine whether daily administration of oral insulin from age 4 to 7 months until age 3 years reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood.
The INGR1D study is due to conclude in February 2021 and POInT is expected to be completed by January 2025.