Pregnancy and diabetes: the 1st device approved

News from the 14th Congress on Diabetes in Pregnancy 'One day on Hyperglycemia in Pregnancy'

Stress-less pregnancy and diabetes: the 1st device to continuously monitor blood sugar for expectant mothers has been approved

The 1st device that can now be used during pregnancy has obtained the CE mark.
A scientifically proven therapeutic option -[1][2] to improve the health and quality of life of mother and unborn child

Rome, 16 October 2020 - How to help all the women with diabetes who are about to become mothers overcome stress? For all pregnancies complicated by diabetes in its various forms (overall about 12-15% of all pregnancies), technology provides a new solution based on the 1st device approved for pregnant women to continuously monitor blood sugar. A simple, accurate system that has received the CE mark for use in pregnancy without the need for calibration, and which helps stabilize maternal control and reduce risks for the baby such as neonatal macrosomia and other complications.

This was discussed during the 14th edition of the conference gathering international and national clinicians to discuss the latest updates on the management of diabetes in pregnancy (Rome, "14 th One day on hyperglycemia in pregnancy ").

PASSWORD: PLAN

It has long been known that pregnancy in women with diabetes must be planned.

" A woman with diabetes should have stable glycemic control - explains Elisabetta TORLONE, endocrinologist and coordinator of the AMD SID Diabetes and Pregnancy Intercompany Study Group - so as to prevent worries and fears related to possible complications, including serious ones for the mother and child. The gestation period should be experienced as one of the most beautiful moments in the life of a woman and a couple, despite the unavoidable apprehension and concern associated with it".

THE UNCERTAINTIES OF AN UNSCHEDULED PREGNANCY

If the woman discovers that she is expecting a baby and does not have good glycemic control, all therapeutic strategies need to be implemented.

"It has long been known that pregnancy in women with diabetes must be planned in order to achieve rapid and stable improvement of the relevant values to achieve and maintain good metabolic control, critical to the health of both mother and child, including in the long term – says Ester VITACOLONNA, Department of Medicine and Sciences of Aging, University of Chieti-Pescara. In women with diabetes an planned pregnancy along with insufficient metabolic control may not only undermine health, but also serenity and quality of life, which take up even more importance in a period like this. “Achieving and maintaining good glycemic control while planning pregnancy is not always easy and can take longer than expected. This may disappoint the expectations of the couples who do not want to delay the pregnancy. Continuous blood glucose monitoring (rt-CGM) together with therapeutic education can be very valuable tools to achieve the intended goals”, ensures Laura SCIACCA, Department of Clinical and Experimental Medicine of Catania University.

WHY CONTINUOUS GLUCOSE MONITORING MAKES THE DIFFERENCE

“Among the unquestionable therapeutic strategies available, the support of continuous blood glucose monitoring technology (rt-CGM) makes the difference in a delicate situation such as pregnancy. For the entire duration of gestation, glycemic control must be as stable as possible and within defined glycemic values (63-140 mg / dl), as recommended by the most recent International Consensus on the topic of glycemic targets1 - explains Angela NAPOLI, MD Specialist in Endocrinology and Diabetology and Internal Medicine at the Sant'Andrea Hospital in Rome, Department of Clinical and Molecular Medicine, of La Sapienza University - The technology (now increasingly simple and accurate) together with continuous education, become the companions of a unique adventure for every woman, even more challenging with diabetes ". 

Until now, no technology belonging to the rt-CGM category had yet been approved for this indication. The scientific evidence has confirmed the impact in terms of neonatal outcomes and on the mother as well as the high accuracy of data for all glycemic values. It has also confirmed the predictive data for rt-CGM hypoglycemia which, for the remainder of the population with diabetes, had already obtained approval for use without the need for glucometer data confirmation or calibrations.

In addition to filling a regulatory gap in the first place - concludes ANGELA NAPOLI - this option is increasingly a conscious choice to achieve good metabolic control, to manage the necessary changes in therapy during pregnancy and to ensure maximum flexibility". The technology (now increasingly simple and accurate) together with continuous education, become the companions of a unique adventure for every woman, even more challenging with diabetes". 

FINAL APPROVAL FOR USE IN PREGNANCY

Noninvasive and small, wearable and wireless, lasting ten days, approved for use in different sites of the body, including the arm, where it has been most successful and demonstrated the highest accuracy even in pregnant women with diabetes (in its various forms). These are the characteristics of the Dexcom G6 device which now boasts a new record in the delicate category of expextant mothers.

"We are proud to be able to offer a real service contained within the device (rt-CGM) - explains Cristiano FERRARI, Managing Director of Theras. The device sends information on glycemic values in real time to your smartphone updated every 5 minutes), with customizable alerts for hyperglycemia and hypoglycemia, even when imminent. Furthermore, the possibility of immediate data sharing on other devices, guarantees the tranquility of loved ones who can remotely check the status of their child or elderly mother ".

"The approval recently obtained internationally for use in pregnancy now offers clinicians the possibility of a new conscious choice. We are proud - continues Carlo PISANI, Theras Commercial Director - to be close to all women who can now live the unique moment of pregnancy with greater serenity"

[1]    Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range Diabetes Care 2019;42:1593–1603 | https://doi.org/10.2337/dci19-0028

[2]    Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial, Denice S Feig at all, Lancet 2017; 390: 2347–59