A new type of "hybrid" glucose monitoring system has been approved in Europe, that combines the best advantages of fingerstick testing and existing CGM (continuous glucose monitoring) with a splash of non-invasive tech -- and hopefully we'll have access to it before long here in the U.S., too.
The system is Abbott Diabetes Care's new Libre Flash Glucose Monitor (FGM), announced Wednesday, which will become available in the coming weeks to patients in France, Germany, Italy, Netherlands, Spain, Sweden and the United Kingdom.
This novel technology was first unveiled at the big European Association for the Study of Diabetes (EASD) conference held in Barcelona last year. The name Libre implies "being free" from fingerstick pokes or even the continuous data that streams from a traditional CGM.
The system consists of a little round sensor worn on the skin, and a "receiver" that looks similar to a handheld PDM, which you wave over the sensor to wirelessly pick up data (no kidding!)
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Here's the skinny:
- The disposable, water-resistant round sensor is the size of a silver dollar and the width of a finger, similar to a traditional CGM sensor. You can wear it for up to 14 days on the back of your upper arm.
- No finger prick calibration is needed, since that functionality is all embedded into the core technology.
- Glucose readings can be taken as many times per day as needed or desired, with only a painless one-second scan. Results are transmitted to the receiver via wireless radio frequency tech.
- The scanning device is a wireless touchscreen color reader, which looks similar to a traditional meter, or more specifically an OmniPod Personal Diabetes Manager (PDM). Just wave the reader over the sensor as often as you want to get real-time glucose values, along with a trend arrow and graph showing the past 8 hours of data. It holds 90 days worth of blood sugar data.
While you do get trend data, the Freestyle Libre doesn't offer the same kind of alarms that a traditional CGM sets off when you go low or high -- something Abbott describes as a good thing, as patients won't have to deal with issue of "alarm fatigue." An advantage is that the system stores 8 hours worth of data, so if you wander off or forget the reader you can just scan it later in the day to view stored data. Nice!
The whole concept behind FGM is the information it provides, in what's called Ambulatory Glucose Profiling (AGP) that's supposed to be better and more actionable to use than either glucose meter or CGM data. Instead of gaps between blood sugar values you might see with meters, or the spaghetti-style color lines with massive amounts of data points on CGM software, the AGP aims to present all that info more simply and clearly so you can act on it, as illustrated below. And yes, Abbott says the software will be compatible with both PCs and Mac computers!
How accurate will it be?
Abbott execs have said during conference presentations over the past year that FGM will be at least as accurate as their Freestyle Navigator CGM tech, which is now only available overseas after it was discontinued here several years ago. At the ATTD (Advanced Technologies & Treatments for Diabetes) early this year, Abbott presented data showing FGM had an accuracy within 9.7% compared to Freestyle Lite meter results and within 8.5% of clinical lab blood draws. For the record: That's pretty darn accurate!
The company still hasn't said if it plans to bring the Navigator 2 here to the States, and this Libre system won't communicate with the Navigator. But Abbott's public affairs manager Jessica Sachariason says the company does plan to bring this FGM tech to the States, and they've been meeting with FDA decison-makers about the regulatory process. Still, for now, there's no expected timeline on when we might see this Freestyle Libre here in the U.S.
And what will this cost, in comparison to CGM?
"In regards to pricing, we're not disclosing specifics at this time," Sachariason told us. "It will be priced significantly less than continuous glucose monitoring, but a bit more than (traditional) blood glucose monitoring."
She also says: "In addition to the elimination of routine finger pricks and many of the inconveniences that occur with blood glucose monitoring, the design of the AGP report used with the FreeStyle Libre system are more user-friendly and provides clinicians the information necessary to make informed treatment decisions. Much of the clutter of traditional reporting has been eliminated. Clinicians will have an easy tool they can use with their patients to discuss their glucose profile throughout a typical day. It is as much a way for clinicians to make therapy adjustments for their patients as a means to change the at-home behavior of the patients themselves."
This certainly sounds promising, if for no other reason than it seems it could free us patients from our dependence on expensive strips needed for traditional glucose meters (for many, the most costly aspect of diabetes management). We can't wait to hear more about how low-cost this turns out to be, and Abbott's eventual plans for U.S. rollout.
That's all we know for now, though it looks like there's going to be an EASD meeting presentation on this new technology on Sept. 15. And from the previews, it appears that international D-blogger Claudio from Trip Therapy will be in the spotlight, highlighting his test use of this new FGM tech while traveling the world. So we'll keep our eyes peeled for the patient perspective there!