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FreeStyle Libre

MamaSarah

MamaSarah

Newbie
Good Morning,
I am an expecting mother with gestational diabetes in the US. My endocrinologist just gave me a FreeStyle Libre along with a regular glucose monitor. When reading the user manual for the Libre, I noticed it said in bold words not to be used by pregnant women, without any other information. However, it HAS been approved in the UK, and this site published an article about its approval in August 2017. I am curious, can anyone tell me if the concern for safety had anything to do with the sensor being dangerous to the baby? A note about not using it in patients with pacemakers made me wonder if the components of device itself were suspected to be dangerous. I've not been able to figure out WHY is it not recommended for pregnant women in the US and hope someone can shed some light on the subject. Thanks!
 
Hi, @MamaSarah , always interesting to hear from people on the other side of the pond!

I think it's just the FDA being paranoid and/or having slower or more rigorous tests.

I wasn't really following the politics of it, but libre was available in Europe long before it was approved in USA. I recall posts by Americans who were going to elaborate lengths to have family/friends buy it in Europe and ship it to them. Maybe Abbott were just using us as testing guinea pigs before letting it loose stateside!

It's certainly approved for use in pregnancy here. The UK version of their site has a whole page about it:
www.freestylelibre.co.uk/libre/discover/diabetes-management-pregnancy.html

I noticed this site:
https://clinicaltrials.gov/ct2/show/study/NCT02665455?sect=X30156

It's got a .gov domain name, so seems to be "official" and it's about a clinical trial of using libre in pregnancy with updates in Dec 2017.

I've no idea how the FDA works, and haven't looked through all of the link, as I'm tapping away on a mobile at the moment, but as the .gov extension suggests it's vaguely official, I suspect that Abbott have to run a few tests in order to satisfy FDA before they can officially say it's ok for pregnancy.

I can't think of anything about libre which would cause any harm during pregnancy.

It might be that their concern is that they know that insulin users will sometimes, after time learning it's quirks, use it for insulin bolusing decisions - it's licensed for that in America. Although it's an incredibly useful device, it does have its quirks, so bolusing from it carries a degree of risk, and it might be that FDA isn't prepared to take that risk and approve for pregnancy until there's more evidence. But I'm just speculating here.
 
Thank you for this information! It makes perfect sense that the FDA is possibly paranoid and taking its time, as pregnancy is an understandably delicate topic when it comes to testing. I certainly don't want to be the guinea pig in this particular situation, but you have put my mind at ease that my concerns are likely separate from the true issue. I'm definitely not the type to abuse the convenience of the device. Thanks again for your response!
 
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