NEWBIE Validate
Research type
Research Study
Full title
Feasibility of a new test to measure glucose in newborn blood spots
IRAS ID
291076
Contact name
Timothy McDonald
Contact email
Sponsor organisation
Royal Devon and Exeter NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Neonatal Diabetes Mellitus (NDM) is a rare disease diagnosed in the first 6 months of life. The disease is caused by mutations (mistakes) in genes responsible for insulin production. Insulin is a hormone that helps move glucose from the blood into our cells. With too little insulin, the body can no longer move glucose from the bloodstream into our cells, causing high blood sugar, which is harmful to tissues and organs. NDM may not be recognised until the blood sugar level is so high that the baby becomes severely ill and is admitted to hospital. Some babies die, and those that do not may be left with life changing brain damage and needing to be in institutional care for life.
Key to improving care would be the ability to diagnose NDM as soon as possible. Effective treatment could be started quickly, reducing the serious risks to the infant. Currently, there is no effective screening test to identify babies at risk of developing NDM. As part of routine care in the UK all babies have a heel-prick blood test at 5-7 days after delivery. This blood spot sample is used to screen for several rare diseases to allow early detection and treatment; this is the obvious time to screen for NDM.
We have developed a way of measuring blood glucose from a blood spot and we have previously shown that glucose levels in blood spots from day 5 of life in those with NDM is raised and markedly higher than normal.
For a new screening test to reach an evaluation stage and be considered for implementation on the newborn screening programme, we must first ensure that laboratory testing pathway is feasible, and the assay has a carefully established cut-off to define what level glucose is abnormal at day five of life.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/PR/0886
Date of REC Opinion
22 Dec 2020
REC opinion
Favourable Opinion