PROTECT PRegnancy Outcomes using continuous glucose monitoring TEChnology in pregnant women with Type 2 diabetes: A multicentre randomised controlled trial of the clinical and cost-effectiveness of using continuous glucose monitoring in pregnant women with type 2 diabetes

RESEARCH QUESTION: What is the clinical and cost-effectiveness of using continuous glucose monitoring (CGM) compared with standard care, for improving maternal glucose and neonatal health outcomes in pregnant women with type 2 diabetes? BACKGROUND: The prevalence of EARLY-ONSET type 2 diabetes (T2D) is increasing with serious public health consequences. Pregnancies in women with T2D in the UK have DOUBLED in the last 15 years. These women face striking healthcare inequalities; 90% are overweight or obese, 70% live in poverty and 60% are from Asian, Black and mixed ethnic groups. National audits highlight the lack of medical attention paid to these women with complex physical, mental & social problems, who like many in the Ockenden report, 'feel ignored'. Almost 50% experience poor pregnancy outcomes (neonatal care admissions, birth defects, baby deaths) despite compelling evidence that improving maternal glucose improves neonatal health outcomes in T2D pregnancy. Continuous Glucose Monitoring (CGM), a device which automatically measures glucose, empowers pregnant women to manage their own glucose levels. It alerts them if their glucose is too high or too low. CGM data are held on phones & shared virtually with followers (partners/family) and clinicians providing support & targeted diabetes treatment adjustments. We have shown that CGM improves maternal glucose, reduces neonatal complications and is cost-effective in T1D pregnancy. Based on our study, CGM is now standard care in T1D pregnancy. There are no well-designed trials of CGM compared to self-monitoring of blood glucose (SMBG) in T2D pregnancy. AIMS: We will examine whether using CGM improves maternal glucose and neonatal health outcomes in T2D pregnancy. We will also measure its impact on maternal wellbeing, diabetes treatment satisfaction and cost effectiveness outcomes. METHODS: A multi-center open-label randomized two-arm parallel group trial with an internal pilot phase and embedded qualitative and health economic research. We will recruit 422 women with T2D during early pregnancy from 20 NHS maternity sites. Women will be randomized to use CGM or SMBG (1:1 ratio) throughout pregnancy. Both groups will aim for the NICE pregnancy glucose targets of 3.5-7.8mmol/L. Outcome assessments are at baseline, 28, 32, 36 weeks gestation & hospital discharge with patient reported outcomes (quantitative & qualitative) at baseline & 36 weeks. The primary maternal outcome is time in target glucose range from 28-38 weeks. The primary neonatal outcome is neonatal care admission or death. Maternal quality of life (EQ-5D scores), NHS resource use and the incremental cost & incremental effects of CGM use will be measured. An internal pilot will recruit 142 women over 12 months to address the feasibility of recruiting & randomizing women with T2D from geographically representative sites and their willingness to use CGM. A nested qualitative study will explore barriers and facilitators to CGM use and any variations by socio-demographic factors. A sample of n=422 is needed to observe a reduction in neonatal care admissions from 42% to 26% with ~ 10% attrition. This is based on national T2D audit data (NPID 2020) & the CGM effect size (OR 0.48) in our T1D pregnancy RCT (Lancet 2017). TIMELINES: 9 months set up, internal pilot 10-21 months, recruitment ends month 35, neonatal outcome data month 44, final analyses/reports month 48. IMPACT: Our findings will inform future NICE guidance.