Comparing CGM with SMBG in gestational diabetes
Research type
Research Study
Full title
Randomised controlled trial to compare interstitial glucose monitoring with self-monitoring of blood glucose in gestational diabetes
IRAS ID
234973
Contact name
Michael Cummings
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Gestational diabetes (GDM) develops during pregnancy, and is becoming increasingly common. High blood sugar levels are associated with problems for both the mother and baby during pregnancy and delivery, including large birth weight, birth injury, low blood sugar levels in the baby and the need for a caesarean section.
Women with GDM are advised to test their sugar levels 6 times per day in order to keep sugar levels within recommended targets, and to guide decisions about treatment, aiming to reduce the risk of complications. Currently women with GDM use finger-prick testing to measure their sugar levels at home; however we know that testing may not be undertaken as often as advised, for several reasons.
In this study we wish to assess whether using a continuous glucose monitoring (CGM) sensor instead of finger-prick testing results in a more reliable acquisition of glucose levels compared with standard finger-prick testing, and in consequence whether this helps achieve improved overall sugar levels at the end of pregnancy.
We will recruit women to the study when they are diagnosed with GDM. Women will be allocated to one of two arms – either using finger-prick testing or CGM sensors. We will also record sugar levels at the beginning and end of the study, using another sensor that obtains glucose data for health care professionals, for comparison. We will also collect information about the birth, including baby’s birth weight.
GDM usually resolves quickly once the baby is born, but it is not clear how rapidly this occurs. The final part of the study uses a CGM sensor for the first 2 weeks after the baby is born, to observe sugar levels during this period. It will be optional for women to take part in this sub-group.
This study will take place at Portsmouth Hospital NHS Trust.REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0089
Date of REC Opinion
6 Mar 2018
REC opinion
Favourable Opinion