SPRING study
Research type
Research Study
Full title
Study of precision and reproducibility of non-invasive glucose testing with the LabClasp
IRAS ID
297538
Contact name
Claire L Meek
Contact email
Sponsor organisation
Cambridge Universities NHS Foundation Trust & University of Cambridge
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Diabetes affects 45,000 pregnant women in the UK each year. It is associated with significant pregnancy complications affecting mother and child, including stillbirth, difficult deliveries, large-for-gestational age and neonatal hypoglycaemia. These complications can be mitigated by accurate diagnosis and management. However, current diagnosis and monitoring of diabetes is unsatisfactory: the oral glucose tolerance test (OGTT) is widely recommended but is unpleasant and performs poorly as a diagnostic test. Monitoring with finger prick glucometer testing is invasive and inaccurate. The aim of this study is to assess if a novel, non-invasive glucose testing device, the LabClasp, has sufficient accuracy for use in pregnant women. Specifically, we will assess if the LabClasp is safe, tolerable and accurate through a quantitative clinical study and qualitative interviews.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0074
Date of REC Opinion
27 May 2022
REC opinion
Favourable Opinion