Abbott FreeStyle® Libre Approved for Sale - Sensor Based Glucose Meter

Diabetes Technology Insulin Pumps
1

Abbott has gotten EU approval for sale of it's new glucose metering system that has a sensor that lasts up to 14 days. It allows you to test as many tests as desired during the day and should be available within the coming weeks in selected countries in Europe. It is unclear how accurate the system is as accuracy data is not publicly available.

Abbott Receives CE Mark for FreeStyle® Libre, a Revolutionary Glucose Monitoring System for People with Diabetes

  • FreeStyle Libre System eliminates routine finger pricks for glucose measurements1 and requires no finger pricks for calibration
  • Available for people living with diabetes in several European markets beginning in the coming weeks
  • Advanced Ambulatory Glucose Profile software presents data in a user-friendly, visual chart, enabling productive treatment discussions

September 3, 2014

ABBOTT PARK, Ill., Sept. 3, 2014 — Abbott today announced that it has received CE Mark (Conformité Européenne) for its FreeStyle® Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for people with diabetes. The system eliminates the need for routine finger pricks, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed—a key differentiator from current continuous glucose monitoring systems. The system will be available in seven countries across Europe in the coming weeks.

Key features of Abbott's FreeStyle Libre System include:

  • The system requires no finger prick calibration
  • Disposable, water-resistant sensor can be worn on the back of the upper arm for up to 14 days
  • Glucose readings can be taken as many times per day as needed or desired, with a painless one second scan
  • Each scan provides a current glucose reading, 8-hour history and the direction glucose is heading
  • The data generated by the system is designed to provide actionable trends and patterns that may help people determine how to modify food and other behaviors to better manage their diabetes in consultation with their healthcare professionals

For more information see the Abbott Press release.

1 Like
2

If it works...:-)

3

if it is accurate, then i would be all for it! especially being a guitar player, i couldn't imagine a life without finger sticks. now they can work on how to get rid of the "pager". Maybe an app for a smartphone with the readouts or incorporate it into a watch.

4

You all know I am the one person on the planet who wants a cgm like I want a hole in my head, so I admit my knowledge of them is sketchy, but aren't they describing a cgm?

5

yeppers. Apparantly, you place a sensor, probably something like a circular bandaid on the back of the arm and i'm guessing it somehow measures blood flow thru a set distance over a set time and counts the sugar or something and relays the info to the unit and it calculates blood sugar. They say it is non-invasive which means nothing penetrates the skin so it doesn't hurt unlike a regular cgm that has a little tube inserted into the body.

I tried a cgm once and it was horrible. My doctor wanted to test it out to see how i like it and it wasn't for me. It was uncomfortable to wear and it was not accurate at all. I test my sugars 4 times a day with a normal meter and this thing needed to be calibrated twice a day so i had to check my sugar twice a day anyway for that. I was still having to do the finger sticks so what was the point. plus it would be off by 50-70 points sometimes. after about a week of that i went back to finger sticks as normal.

6

Yes and no.

While the data capture is continuous, the monitoring is not -- you only access the data when deliberately passing the reader over the sensor and collect new data since the last time the sensor was scanned.

Because of this, monitoring is not continuous -- you will get no alerts or warnings for rising or falling BG, hypo, etc.

As such, it is much more like a substantially improved BG meter than a CGM. Really, it is kind of a hybrid between the two -- BG is measured similar to a CGM, data is viewed and interpreted on-demand in a passive way, like a BG meter.

By using NFC standards for the radio commication and protocol, the sensor is ready as is to work directly with a smartphone app on any smartphone that supports NFC (most do these days). However, NFC is not a continuous communication technology, but rather a very low-power "event" based communication tech. Hence the need to swipe the reader (dedicated device or smartphone) right over the sensor.

This choice has many advantages given the growing presence of NFC for electronic payment, RFID, and other uses. The down side is that, because of the short range, the sensor can not transmit a continuous stream of data to the reciever for processing and monitoring.

This is an exciting technology for those that do not need a CGM, but want continuous data in order to better manage their BG. If you don't need the active monitoring of a CGM, this is probably a superior solution. I'd be very interested in this device as a substitute for my G4.

I don't think this is a viable replacement for most T1s using a CGM. A T1 needs to be warned when BG is rising (bad infusion site, for example, or bad insulin injected with a pen), or, particularly for those hypo-unaware, when going hypo.

T2s like myself that are pumping and tight controlling, but have enough beta function to keep out of DKA or HHNS are perfect candidates for this device.

That is, if it's accurate. My G4 is scary accurate (last 2 times I calibrated it in the past 24 hours it exactly matched my BG reading on my meter). I'd toss my G4 in a heartbeat for this Abbot sensor if it's accurate enough, and cheaper. Seems to have a better "footprint".

7

It is accurate and based on their Navigator electrochemical sensor but I don't see the point compared to the ability to see continuous readings like with Navigator or Dexcom. Dexcom is already evolving their system to be calibration-free so unless the Libre is significantly cheaper or the bodyware is notably smaller or some other advantage, I don't see the point.

8

The press release states the following on the Abbott site:

Abbott's FreeStyle Libre System consists of a small, round sensor—approximately the size of a two Euro coin—worn on the back of the upper arm, which measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad.

Unfortunately, it does penetrate the skin just like a CGM, so there's no difference there. And without continuous streaming of data, it seems to be at a bit of a disadvantage vs. a CGM - especially now that we know that Dexcom's next generation sensor will broadcast directly to a smartphone app and it will not require calibration either.

9
unless the Libre is significantly cheaper or the bodyware is notably smaller
This.

Given their choice of NFC as a communications technology, the whole thing should be quite a bit less expensive.

10

NFC can improve the cost of the transmitting battery? Maybe a disposable 14 day battery/transmitter knocks down the system cost appreciably vs Dexcom's dedicated $600 transmitter. But the sensors are still going to be $30+ each (after insurance).

11

I wonder how hard it would be to make this a true CGM with continuous data transmission, i.e. build a transmitter yourself. If this is indeed using NFC and they don't encrypt the data it might not be too hard to combine an NFC reader with a Bluetooth low energy transmitter and implement alerts on your phone.

12

One other feature of this near field communication device is that it does not need to be calibrated. Abbott is saying that this thing is accurate enough to be equivalent to a fingerstick meter when making dosing and correction decisions. I'd love to get a CGM sensor that needs no calibration.

I'd trade my fingerstick meter for one of these, but still need the hypo alarm of the CGM. I'm running out of real estate!

13

Abbott Diabetes is right across the bay from me, but much prefers customers in Europe. I never used one but many people remember fondly the Abbott Navigator CGM, no longer sold in the US.

The thing that really caught my eye with this announcement is Abbott's embrace and integration of the Ambulatory Glucose Profile (AGP) software in their download software. The AGP is a single page graph that patients can intuitively understand quickly. It enhances the doctor's ability to suggest an effective and safe treatment adjustment. The AGP only needs 14 days of BG data for statistical validity.

The Apple iPhone 6 will reportedly have near field communication.

14

Here is a video: https://www.youtube.com/watch?v=0cXwO9YBJxE

15

Compared to a fingerstick meter? I'd love to make this trade. Nice video.

16

Could we use this in addition to dex? why prick when you can scan, lol... I like it!

17

The way I look at it, due to its lack of alarms, it acts more like a fingerstick meter than a CGM. But it can be read dozens of times per day rather than the 5 or 10 or less that most PWDs do with fingersticks. Combined with its no-calibration read-outs, I think this is a strong product that I'd certainly use, if given the chance.

FDA, what say you?

18

H*ll yes!

Most RFID tags don't even have a battery. They're powered by the RF from the reader.

In this case, some tiny continuous current is necessary to keep the device running collecting data, but this can be designed to be extremely low power compared to that required to transmit an RF signal.

Then, power the transmitter of the device seperately, from the reciever RF, just like an RFID tag.

Huge cost difference.

19

Nice!

Thank you, FDA. We diabetics really appreciate, very much, you protecting us from this obviously dangerous, risky technology.

I'm glad we have the FDA too keep us from having access to information like this. Our government knows we will kill ourselves with it.

(all heavy sarcasm, in case anyone didn't get it)

20

Pretty close, except it does provide continuous data acquisition -- i.e. it's taking readings constantly and storing them, even when you're not scanning.

As such, it can provide trend information at each scan, something that isn't available with a single finger stick.

I think this product, if priced properly, can hugely cannibalize the existing fingerstick meter market. Also, as one who wears a G4 sensor all the time, that much lower profile sensor looks really good.