RECOGNISE - a feasibility study
Research type
Research Study
Full title
"RECOGNISE” – taRgeted intermittEnt gluCose mOnitoring for the management of GestatioNal dIabeteS mEllitus– A Feasibility Study
IRAS ID
312370
Contact name
Christy Burden
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN42125256
Duration of Study in the UK
1 years, 8 months, 25 days
Research summary
Aim:
Is it possible to carry out a large-scale randomised study to see if wearing a continuous blood sugar monitor improves mother and baby health in women with Gestational Diabetes Mellitus (GDM)?
Background:
GDM is high blood sugar, developed during pregnancy. It affects approximately 10% (70,000) of UK pregnancies yearly.
GDM can cause: large baby (less safe to deliver); early birth; caesarean-section; baby needing intensive care; baby death; future obesity-related problems for baby.
These risks are costly for the NHS. Importantly, they can be reduced by controlling blood sugar during pregnancy.
Usual care for monitoring blood sugars in GDM is “finger-prick” testing. But, using an intermittently-scanned Continuous Glucose Monitor called "Flash" could be better. Flash is continuously worn on the arm and scanned with a Smartphone/reader to easily and consistently see accurate sugar levels. Blood sugar results guide women and help their doctor select appropriate treatment.
Studies show Flash monitoring for pregnant women with Type1 (pre-existing) diabetes reduces pregnancy complications and saves money compared with “finger-prick” testing. No-one has investigated whether Flash devices could make pregnancy safer for women with GDM and their babies and save NHS costs.
Methods:
We will recruit 60 pregnant women with GDM and poorest blood sugar control and randomly-allocate them to use “finger-pricking” (usual care) OR Flash monitoring.
We will:
Evaluate how many: agree to take part (be recruited) and randomised; use Flash correctly; complete self-reported assessments; and whether medical/cost information can be collected to assess effect of Flash on mother and baby health and cost-saving.
Interview <38 of the women to see if: Flash is acceptable and easy to use, its advantages/challenges, and whether this varies between socio-demographic groups; they were happy being randomised to use “finger-pricking” OR Flash.
We will interview 10 staff (Drs/nurses/midwives) to see if Flash is helpful for managing GDM.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0246
Date of REC Opinion
16 Aug 2022
REC opinion
Favourable Opinion