Real-time Glucose Control During Pregnancy Gets CE Mark

Becky McCall

February 27, 2020

Dexcom G6 CGM (continuous glucose monitoring) system has received the CE mark for use during pregnancy in the European Union (EU), starting in the UK from the beginning of April, according to the developer, Dexcom.

"Dexcom G6 is the first real-time CGM with a CE mark for diabetes in pregnancy, and its availability gives women choice between the two approved devices during pregnancy [the other is FreeStyle Libre, Abbott]," said Prof Helen Murphy, clinical professor in medicine (diabetes and antenatal care), Norwich Medical School, University of East Anglia, who has led recent studies into CGM use in pregnant women with type 1 diabetes.

The device provides women with much more real-time information to manage their glucose levels, minute to minute, day to day, so they can adjust diet, and insulin, added the researcher and clinician. Women with type 1, type 2, or gestational diabetes usually require six or more finger-prick tests per day. CGM eliminates the need for finger-pricks and provides patients with regular updates and alerts throughout the day and night.

"This is really exciting, partly because it is the only real-time CGM with an alarm. Right now, we use the Libre [FreeStyle Libre] that is very good and has a CE mark for use in pregnancy, but it is not a real-time CGM," Prof Murphy explained. 

According to developer, the Dexcom G6 gathers real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode. In the unblinded mode, patients can see their glucose data on a mobile app to gain insights and make treatment decisions in real time.

The real-time element of Dexcom G6 is so important for women, particularly those with type 1 diabetes, Prof Murphy remarks. "It gives women the confidence to keep increasing doses as needed. As pregnancy progresses, women become more insulin resistant and they need larger doses [of insulin], but there’s a balance to be struck between too much and the mother having a low sugar level, versus not enough with associated complications for the baby."

With the real-time system, an alarm goes off if the woman’s glucose level drops too low. In a type 1 patient, there is some safety in being able to sleep all night knowing there will be an alarm if their glucose level drops below 3 mmol/L, she explained.

Controlling Diabetes in Pregnancy

Inadequate control of diabetes in pregnancy can lead to pre-eclampsia, babies that are large for gestational age (associated with birth complications and long-term risk of obesity and type 2 diabetes), and babies born with low glucose levels who require admission to the neonatal intensive care unit (NICU).

For women with type 1 diabetes outside of pregnancy, the evidence supports the use of real-time CGM with alarms, Prof Murphy pointed out. "We know that there is a benefit of real-time with alarms when there’s a risk of hypoglycaemia, and pregnancy, of course, is a time when there is heightened hypoglycaemia risk."

Real-time CGM in the NHS Long Term Plan

Within the 10-year NHS Long Term Plan, real-time CGM has been approved for all pregnant women with type 1 diabetes from April 1st 2020, and the National Institute for Health and Care Excellence (NICE) is currently reviewing the guidelines.

Last year, Prof Murphy and colleagues conducted a cost analysis that combined data from the landmark CONCEPTT randomised controlled trial (RCT) with cost data from NHS England and the manufacturer to determine the budgetary impact of the use of real-time CGM. This showed that when applied to a cohort of more than 1400 women derived from the 2016 National Pregnancy in Diabetes Audit, the use of CGM would have saved more than £9.5 million.

As  reported  by Medscape Medical News at the time, the CONCEPTT trial showed that CGM improved newborn health outcomes compared with finger-prick testing. "A key benefit of using CGM is in halving the risk of large for gestational age babies, and halving the risk of admission to NICU, and of those babies that do need to attend NICU, they attend for less time," said Prof Murphy.

Health Technology Wales has already appraised data from the CONCEPTT study, alongside those from other studies that have investigated the use of CGM in type 1 diabetes. "They concluded a benefit in maternal glucose levels, and a systematic review [in pregnancy] found that there was a benefit in pre-eclampsia. There was also a reduction in the need for, and duration of NICU each day. SIGN Guidelines in Scotland are also being reviewed in this respect," noted Prof Murphy.  

It is possible to use the Dexcom G6 in type 2 diabetes and gestational diabetes, but the evidence, to date, only supports cost saving with use in pregnant women with type 1 diabetes. There is no evidence yet for type 2 diabetes and gestational diabetes, said Prof Murphy.  

The US Food and Drug Administration (FDA) approved the Dexcom G6 integrated CGM as reported by Medscape in 2018.  It is the first such device designed to be interoperable with different types of compatible devices and electronic interfaces including insulin pumps and blood glucose monitors.

To accompany the CGM device, the Dexcom G6 app enables the sharing of a patient’s glucose information with up to five people who have the separate Dexcom Follow App, meaning family members and clinicians can remotely monitor a patient’s glucose levels if necessary.

"The next step is to roll it out now across the NHS to the 2000 women who need it," said Prof Murphy.

COI: Professor Murphy has received honoraria for speaking engagements from Medtronic, Roche, Novo Nordisk, and Eli Lilly, and is a member of the Medtronic European Advisory Board.

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