About the RECOGNISE Study

RECOGNISE Feasibility Study

An exciting new study is being run in the South-West. Women with newly diagnosed gestational diabetes under the care of the Specialist Diabetic Care Teams at North Bristol NHS Trust and Somerset Foundation Trust may be offered the opportunity to take part in RECOGNISE.

What is this research study about? And why are we doing it?

Aim: 
To find out if it’s 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, just under the skin, 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 continuous blood sugar monitoring for pregnant women with type 1 (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. 

How will the research be carried out?

Methods: 
We will recruit 60 pregnant women with GDM and high blood sugar levels/ control and randomly-allocate them to use “finger-pricking” (usual care) OR a Flash monitor. 

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 up to 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. 

What will be the outputs?

Dissemination/Outputs:
▪ Participants' report. 
▪ Publications. 
▪ Presentations.
▪ Funding application for definite trial (if our results will show us a large-scale randomised study of “Flash” is possible).

What were the outcomes of the Patient & Public Involvement (PPI) group when setting up this study?

Our PPI group were confident this research could improve GDM management and pregnancy experience, including mental wellbeing, which is desperately required. Our PPI work led us to redesign part of this study to focus on the burden of different management techniques and has informed our self-reported outcome measures, to help understand whether women have better/worse experiences of blood sugar monitoring using Flash. Our group will help develop study documentation and inclusive recruitment/communication/dissemination strategies, help produce the final write-up of reports/papers, and guide development of future projects stemming from this research. Group members will form part of our Study Steering Committee, ensuring continuity of the patient voice. 

Project Details:

Chief Investigator: Dr Christy Burden (North Bristol NHS Trust)

Planned End Date: January 2024

Local Ref: 5138