Impact case study database

The results of the UEA led CONCEPTT trial, published in 2017, have been translated into new national and international policy and practice that are having positive impacts on the care of pregnant women with type 1 diabetes, delivering substantial health benefits for those mothers and their babies. In the UK, the NHS anticipates significant cost savings, with reduced pressure on antenatal services, maternity wards, and neonatal intensive care units as well as improved patient experiences.

Changes to National Policy and Guidelines

The NHS accelerated CGM implementation pathway [A, B, C]

Based on the CONCEPTT results, National Health Service England (NHSE) have, in their Long Term Plan [Source A (i)], incorporated an accelerated implementation pathway, with funding for CGM (GBP2,000 per pregnancy) allocated to local maternity services starting from 01 November 2020. Local maternity services must now make CGM available to all pregnant women with type 1 diabetes by March 2021:

“...all pregnant women with type 1 diabetes will be offered continuous glucose monitoring, helping to improve neonatal outcomes.” [Source A (ii) page139]

Among pregnant women with diabetes, the risks of infection and of stillbirth are influenced by the quality of glucose control. CGM improves maternal glucose levels during pregnancy and because live CGM data are remotely shared with healthcare providers, CGM assists patients and healthcare providers in adjusting diabetes treatment during virtual appointments, which is particularly important for safely managing pregnant women during the COVID19 pandemic. The LTP FAQs clearly set out the neonatal health benefits citing the CONCEPTT findings. [Source A (iii) page151]

Similar changes to healthcare policy with ring-fenced CGM funding for all pregnant women with type 1 diabetes to be offered CGM have been introduced in Wales [B] and in Scotland [Source C]. A Technology Evidence Appraisal from NHS Wales reported that CGM use improves glycaemic control and reduces the incidence of pre-eclampsia in the mother, and reduces neonatal hypoglycaemia and the need and duration of neonatal intensive care stay for the baby [Source B (ii)]. NHS Trusts in England and Wales must now adopt this guidance [Sources A, B].

Equality and health inequalities impact assessments to ensure widespread digital inclusion for equitable implementation of CGM for all pregnant women with type 1 diabetes are now underway across all NHS regional maternity networks [Source A (iii)].

Changes to NICE Guidelines [D]

In the wake of the publication of the CONCEPTT findings, multiple professional and patient organisations called for a review of NICE Guidelines. These included the Royal College of Obstetricians and Gynaecologists; the Royal College of Physicians and Surgeons of Glasgow; the Association of British Clinical Diabetologist; the Diabetes Technology Network; Diabetes UK, the Juvenile Diabetes Research Foundation (JDRF) and INPUT Patient Advocacy. NICE issued the following statement:

“There is new evidence on continuous glucose monitoring. In particular, the CONCEPTT trial has published which experts deem to be a landmark trial that provides the best available evidence for the foreseeable future. The CONCEPTT trial found improvements in a range of neonatal outcomes with continuous glucose monitoring… and advocates routine usage in pregnant women with type 1 diabetes.” [Source D(i)]

The NICE guideline review, published December 2020 [Source D (iii)], states that, based on high quality randomised controlled trial data (taken from the CONCEPTT trial), continuous glucose monitoring (CGM) resulted in

• More pregnant women achieving the blood glucose targets

• Fewer caesarean sections

• Fewer neonatal intensive care unit (NICU) admissions

The current NICE guideline now states:

“Offer continuous glucose monitoring (CGM) to all pregnant women with type 1 diabetes to help them meet their pregnancy blood glucose targets and improve neonatal outcomes.” [Source D (ii)]

Patient organisations [E]

These national policy and guideline changes are strongly endorsed by patient organisations including Diabetes UK, who issued a Position Statement recommending that, for pregnant women, “ real-time CGM with alarms should be considered as first-line therapy” [Source E (i)] and the Juvenile Diabetes Research Foundation (JDRF) who stated that:

“The provision of CGM will help keep mothers and their babies healthy, and will help set world standards for the provision of medical technology for pregnant women with type 1 diabetes.” [Source E (ii)]

Cost and Other Resource Benefits to the NHS [B, F]

Initial cost modelling estimates by NHS Wales point to immediate savings of GBP1,029 per pregnancy from the reduction in neonatal intensive care requirements [Source B (i)]. A budget impact model (conducted by the CONCEPTT team and CGM device manufacturers) has estimated that the annual saving to the NHS from managing type 1 diabetes pregnancy using CGM will be in the region of GBP9,500,000 annually (with current costs running at close to GBP24,000,000, and those post implementation at just over GBP14,000,000) [Source F].

Driving Change in Policy and Practice Overseas [G, H, I, J]

Based on the CONCEPTT results, because of the low use of CGM prior to 2019, time-in-range glucose targets for CGM use are being introduced into clinical research and into policy and practice frameworks for managing diabetes during pregnancy internationally [Source G (i)]. CGM time-in-range is the only glucose outcome measure that both reflects patients’ priorities and can be used to quantitatively evaluate treatment efficacy.

Furthermore, research funders now recognize CGM time-in-range as a primary outcome measure in national and international type 1 diabetes pregnancy clinical trials [Source G (ii)].

In the USA, CGM use in type 1 diabetes pregnancy has increased from 17% to 36% [Source H (i)], and was endorsed by the 2020 American Diabetes Association (ADA) standards of care, which stated that CGM can help achieve glucose control targets, reduce macrosomia (excessive birth weight) and neonatal hypoglycaemia [Source H (ii]).

In Australia, eligibility for fully subsidised continuous glucose monitoring was expanded under the National Diabetes Services Scheme in 2019 to include: women with type 1 diabetes who are pregnant, breastfeeding or actively planning pregnancy. On 1^st March 2019, the Hon. Greg Hunt, Minister of Health, stated:

“Funding over the next five years will assist 37,000 eligible Australians with type 1 diabetes through the expansion of the Continuous Glucose Monitoring (CGM) Initiative.” [Source I]

Likewise, in Sweden, the use of CGM is now reimbursed both before pregnancy and as part of routine antenatal care:

“In Sweden, the use of CGM is reimbursed in type 1 diabetes outside of pregnancy if adequate glucose control is not achieved by conventional methods, and for all women in pregnancy.” [Source J]