Successful integration of newborn genetic testing into UK routine screening using prospective consent to determine eligibility for clinical trials.

ABSTRACT:

Objective

INGR1D (INvestigating Genetic Risk for type 1 Diabetes) was a type 1 diabetes (T1D) genetic screening study established to identify participants for a primary prevention trial (POInT, Primary Oral Insulin Trial).

Methods

The majority of participants were recruited by research midwives in antenatal clinics from 18 weeks' gestation. Using the NHS Newborn Bloodspot Screening Programme (NBSP) infrastructure, participants enrolled in INGR1D had an extra sample taken from their day 5 bloodspot card sent for T1D genetic screening. Those at an increased risk of T1D were informed of the result, given education about T1D and the opportunity to take part in POInT.

Results

Between April 2018 and November 2020, 66% of women approached about INGR1D chose to participate. 1

SUBMITTER: Bendor-Samuel OM 

PROVIDER: S-EPMC9763160 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature