Title: Non-invasive Diagnosis and Monitoring of Gestational Diabetes
Funder: Department of Health and Social Care

Abstract: The aim of this project is to test the LabClasp in pregnant women to assess: If it can measure glucose accurately if it is easy to apply and comfortable to wear Background to the project Gestational diabetes, which arises for the first time in pregnancy, affects around 40,000 women per year in the UK and causes pregnancy complications affecting mothers and babies. Women normally require a 2-hour hospital test to diagnose gestational diabetes (oral glucose tolerance test; OGTT) but this test is inaccurate and unsuitable during the pandemic. After diagnosis, women have to monitor their glucose (sugar) levels 4+ times daily using fingerprick testing which is painful and invasive. We urgently need better home-based ways of diagnosing and monitoring gestational diabetes. The LabClasp offers an opportunity for non-invasive diagnosis and monitoring of gestational diabetes. The LabClasp is a lab-on-a-chip which can measure glucose levels through the skin. Earlier versions of the LabClasp have been found to give accurate glucose measurements and be comfortable for patient use. The latest version, with streamlined industrial manufacture, is expected to have similar or greater accuracy, but has not been tested in pregnancy. Design of project 50 pregnant women will be recruited to have their standard NHS diabetes test with simultaneous glucose measurement using the LabClasp. Glucose will be measured using the LabClasp in addition to the gold standard test for glucose. We will use this data to assess the accuracy of the LabClasp. As this study requires no additional visits to hospital, this is feasible during the pandemic. 20 women who participate in the study will be asked to take part in qualitative interviews. We will ask questions about how easy the LabClasp is to use, and whether women found it comfortable to wear. To reduced face-to-face contact during the pandemic, this interview will be performed using the internet/telephone. Funding has also been requested for product development to allow wireless use of the LabClasp. This is essential for future larger-scale studies. Patient and public involvement This application has already been supported by our PPI group, GDM Voices , who will continue to support the project if funding is awarded. The PPI group will be asked to provide ongoing advice and guidance for product development. In addition, women who use the LabClasp during the studies will also be asked their opinions about the device, and will be invited to join the PPI group. Expected outcomes By the end of the project, we expect to have an accurate wireless device that can interface with a smartphone, leading to an in-home device for clinical-grade monitoring of GDM. Dissemination Results will be disseminated via a conference specialising in diabetes technology and using scientific publications and social media.

Lay abstract: The aim of this project is to test the LabClasp in pregnant women to assess: If it can measure glucose accurately if it is easy to apply and comfortable to wear Background to the project Gestational diabetes, which arises for the first time in pregnancy, affects around 40,000 women per year in the UK and causes pregnancy complications affecting mothers and babies. Women normally require a 2-hour hospital test to diagnose gestational diabetes (oral glucose tolerance test; OGTT) but this test is inaccurate and unsuitable during the pandemic. After diagnosis, women have to monitor their glucose (sugar) levels 4+ times daily using fingerprick testing which is painful and invasive. We urgently need better home-based ways of diagnosing and monitoring gestational diabetes. The LabClasp offers an opportunity for non-invasive diagnosis and monitoring of gestational diabetes. The LabClasp is a lab-on-a-chip which can measure glucose levels through the skin. Earlier versions of the LabClasp have been found to give accurate glucose measurements and be comfortable for patient use. The latest version, with streamlined industrial manufacture, is expected to have similar or greater accuracy, but has not been tested in pregnancy. Design of project 50 pregnant women will be recruited to have their standard NHS diabetes test with simultaneous glucose measurement using the LabClasp. Glucose will be measured using the LabClasp in addition to the gold standard test for glucose. We will use this data to assess the accuracy of the LabClasp. As this study requires no additional visits to hospital, this is feasible during the pandemic. 20 women who participate in the study will be asked to take part in qualitative interviews. We will ask questions about how easy the LabClasp is to use, and whether women found it comfortable to wear. To reduced face-to-face contact during the pandemic, this interview will be performed using the internet/telephone. Funding has also been requested for product development to allow wireless use of the LabClasp. This is essential for future larger-scale studies. Patient and public involvement This application has already been supported by our PPI group, GDM Voices , who will continue to support the project if funding is awarded. The PPI group will be asked to provide ongoing advice and guidance for product development. In addition, women who use the LabClasp during the studies will also be asked their opinions about the device, and will be invited to join the PPI group. Expected outcomes By the end of the project, we expect to have an accurate wireless device that can interface with a smartphone, leading to an in-home device for clinical-grade monitoring of GDM. Dissemination Results will be disseminated via a conference specialising in diabetes technology and using scientific publications and social media.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: METABOLIC AND ENDOCRINE;REPRODUCTIVE HEALTH AND CHILDBIRTH