Title: “RECOGNISE” – taRgeted intermittEnt gluCose mOnitoring for the management of GestatioNal dIabeteS mEllitus– A Feasibility Study
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible to conduct a randomised controlled trial (RCT) to evaluate the clinical- and cost-effectiveness of an intermittently scanned continuous glucose monitor(isCGM) device, compared with standard care, for reducing fetal macrosomia and improving pregnancy and health outcomes in women with Gestational Diabetes Mellitus(GDM)? Background GDM is glucose intolerance with onset during pregnancy, typically resolving after birth. GDM affects 5-10%(35,000-70,000) UK pregnancies every year. Poorly controlled GDM increases risk of adverse pregnancy outcomes for mother and child. Improving the management of glucose control reduces risk. Standard care is self-monitoring of capillary blood glucose(SMBG) 4-6 times daily using finger-prick testing. However, SMBG provides an incomplete picture of glucose profiles, due to intervals between finger-pricking. Devices that continuously monitor glucose have been developed. These devices provide information on fluctuations and trends over a whole 24-hour period and alert women to excursions in blood glucose(hypo/hyperglycaemia). There are no large-scale, appropriately-powered, RCTs evaluating such devices for GDM management and the improvement of pregnancy outcomes. We will test the feasibility of an RCT to evaluate the clinical- and cost-effectiveness of an isCGM device for reducing fetal macrosomia and improving pregnancy and health outcomes in women diagnosed with GDM, targeting those with the poorest glycaemic control(taking metformin/insulin). Aims/Objectives The key uncertainties this feasibility study will address are: Is it feasible to recruit and randomise women with GDM? Do women adhere to requirements of the isCGM? Can we collect the data necessary to understand clinical effectiveness, experience and health economic(HE) outcomes(self-report data completeness, glycaemic control monitoring data completeness and extraction from medical records)? Is isCGM acceptable to women with GDM? Does this vary by socio-demographic factors? Do women and healthcare professionals(HCP) find isCGM useful to inform treatment modification/management and to optimise glycaemic control? Methods This study is a multi-centre open randomised-controlled feasibility study, with embedded qualitative research. Women with GDM in pregnancy on insulin or a minimum of 1000mg of metformin/day will be randomised in a 2:1 ratio to isCGM or SMBG. Patient reported outcomes will be assessed at baseline and ~34 weeks' gestation. Women will be followed up post birth and at 13 weeks post-natal. A nested qualitative study will explore acceptability of the intervention and feasibility of conducting a future RCT. This will include interviews with participants in both groups, non-participants and HCPs delivering the intervention. Timelines 24-months with 12-months recruitment, data collection through pregnancy and follow-up at birth and 13 weeks post-natal. HCPs and women s interviews will take place during the recruitment/data collection periods. Impact/Dissemination Dissemination will be designed to engage a range of stakeholders through various routes. We will work with the Steering Committee and PPG to develop our dissemination strategy and communicate findings to a wide audience. Results from this study will guide whether a full-scale RCT to test the effectiveness of the isCGM device intervention in women with GDM is feasible. If the RCT is found to be feasible, this study's findings will inform its design, including quantitative and HE evaluations. An application will be submitted to NIHR HTA.

Lay abstract: 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; and 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 &ldquo;finger-prick&rdquo; testing. But, using an intermittently-scanned Continuous Glucose Monitor called &quot;Flash&quot; 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 Type1 (pre-existing) diabetes reduces pregnancy complications and saves money compared with &ldquo;finger-prick&rdquo; 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 &ldquo;finger-pricking&rdquo; (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 35 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 &ldquo;finger-pricking&rdquo; OR Flash. We will interview 10 staff (Drs/nurses/midwives) to see if Flash is helpful for managing GDM. PPI: 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. Dissemination/Outputs: Participants' report. Publications. Presentations. Funding application for a definitive trial (if our results show us a large-scale, randomised study of &ldquo;Flash&rdquo; vs. usual care is possible).

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