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Abbott announces CE-Mark for FreeStyle Libre 3,

smaller, thinner, and with real-time glucose and trend arrow information

September 28, 2020

 

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läs hela info nedtill - och utdrag aktuell info finns också nedtill

 

Nyhetsinfo

www red DiabetologNytt

 

https://www.closeconcerns.com/knowledgebase/r/e27cabf4?utm_source=Closer+Look+Subscribers+2018&utm_campaign=7bcac515ce-2020-09-27_WIR_EASD202009_26_2020&utm_medium=email&utm_term=0_c55d924bf1-7bcac515ce-412263157

 

Executive Highlights

Table of Contents [hide]

1. “Smallest and thinnest” available sensor sends real-time minute-by-minute readings directly to FreeStyle Libre 3 smartphone app; “unsurpassed” 14-day accuracy

FreeStyle Libre 3 preserves the same optional alarms, 14-day wear, and high accuracy (likely meeting iCGM criteria), while also adding real-time readings sent directly to a mobile app in a 70% smaller (and more discreet) sensor. The third-generation CGM sensor sends real-time, minute-by-minute readings directly to mobile devices via Bluetooth. This is a huge step forward for Abbott: although FreeStyle Libre 2 also has Bluetooth connectivity, which enables optional alarms, the system still required users to scan their sensor at least every eight hours to view their glucose values. By moving from scanning to Bluetooth with FreeStyle Libre 3, Abbott removes what some saw as a burden of scanning, which for many users, was a significant differentiator between FreeStyle Libre and other real-time offerings although some preferred it – presumably they’d continue to get FreeStyle Libre 2. In FreeStyle Libre 3, real-time data is directly sent to the FreeStyle Libre 3 mobile app, which is new with the updated system (since scanning is no longer required) and is available for both iOS and Android devices. Like LibreLink, which was used for FreeStyle Libre and FreeStyle Libre 2, the FreeStyle Libre 3 app enables users to view their real-time data (for the first time without scanning), glucose history, and trend arrows, all features which have been highly popular with earlier FreeStyle Libre models and apps.

2. FreeStyle Libre 3 to launch in “coming months”; list pricing remains same as FreeStyle Libre 2 and FreeStyle Libre, a big deal given the improvements

Abbott didn’t provide many specifics on the hardware changes between FreeStyle Libre 2 and 3. We’d imagine the battery and/or transmitter on the FreeStyle Libre 3 might be more expensive than that of FreeStyle Libre 2 – there could also be added cost from miniaturizing the device. On the other hand, Abbott notes in its press announcement that the smaller size of FreeStyle Libre 3 reduces the total volume by 70%, plastic use by 41%, and carton paper use by 43%. Ultimately, it’s unclear how FreeStyle Libre 3 margins compare to FreeStyle Libre 2, but we salute Abbott’s ongoing commitment to global access with its same list pricing for all three offerings. Of course, what health systems are paying can be different from list price as we’ve seen in the UK where volume purchases by one system have enabled lower pricing.

3. Competitive Implications: FreeStyle Libre 3 strengthens Abbott’s OUS position

With the no-Bluetooth, scan-based FreeStyle Libre “1,” the addition of alarms 

https://www.closeconcerns.com/knowledgebase/r/c98c215a#Competitive_Implications_and_Positioning

in FreeStyle Libre 2, and now real-time data in FreeStyle Libre 3, Abbott has taken a step-wise to delivering its “always-on” CGM option. In our view, the FreeStyle Libre and the FreeStyle 2 had “real-time” sensing but some patients prefer to “scan” to get the number (which is continuously updated) rather than “hear about it” by alarm – the Libre 3 will just have it “always on” and always visible, rather than “on demand.” In hindsight, this seems like a very smart move, as the step-wise approach has allowed Abbott to offer FreeStyle Libre at lower cost. Given the public health implications, we’d rather everyone have either Freestyle Libre 2 or Freestyle Libre 3 and that they’d set the alarms, since we imagine time in range is easier to reach with alarms. Still, some want a more discreet experience and we expect both systems to continue to be popular – we’d expect Freestyle Libre, the first system, to be less popular over time. Lower cost has helped Abbott drive broad access and reimbursement for CGM technology and now, six years after CE-Marking for the original FreeStyle Libre system, Abbott is poised to bring its real-time CGM as well as to continue to bring its Freestyle Libre and Freestyle Libre 2 to those that want it to the existing 2+ million users and beyond. We also note – they all will have the same list price, and we imagine Abbott will be able to be more competitive with large healthcare systems who commit to a large volume.

4. Feature Comparisons between FreeStyle Libre 3, FreeStyle Libre 2, Dexcom G6, G7, Medtronic Guardian Sensor 3, and Senseonics Eversense XL

In this first table, we’ve summarized the key features of Abbott’s FreeStyle Libre 3 and FreeStyle Libre 2 and Dexcom’s G6 and G7 as a comparison given that these two companies hold ~82% of the growing CGM market (by revenue) as of 2Q20. For Dexcom G7, we’ve made certain assumptions about the product features based on publicly available data and statements as the device is not on the market. The yellow highlight denotes which system(s) has the advantage on a particular category; of course, this is our opinion, and some is subjective!

 

FreeStyle Libre 3

FreeStyle Libre 2

Dexcom G6

Dexcom G7

Fingerstick Calibration

None – Factory Calibrated 

No optional user calibration in cases of sensor inaccuracy

No sensor calibration code required

None – Factory Calibrated 

No optional user calibration in cases of sensor inaccuracy

No sensor calibration code required

None – Factory Calibrated

Each sensor has a unique calibration code – captured via photo

None – Factory Calibrated

Accuracy (MARD)

9.2%

9.3%

9.0%

-

Labeling

Non-adjunctive – Replaces fingersticks for treatment decisions

Non-adjunctive – Replaces fingersticks for treatment decisions

Non-adjunctive – Replaces fingersticks for treatment decisions

Non-adjunctive – Replaces fingersticks for treatment decisions

Population

4+ years

4+ years

2+ Years

-

Warmup

1 hour

1 hour

2 hours

-

Wear length

14 days 

14 days

10 days

14-15 days (maybe 16?)

Alarms

Yes – real-time alarms on mobile app

Threshold alerts for highs and lows

Yes – real-time alarms on reader, must scan sensor to see glucose, eight-hour history stored on sensor patch

Threshold alerts for highs and lows

Yes – data sent continuously to two display devices – receiver and app

Predictive alerts for lows

Yes – data sent continuously to two display devices – receiver and app

Predictive alerts for lows

Data display

FreeStyle Libre 3 mobile app  (iOS and Android) for viewing real-time data

FreeStyle Libre reader device and LibreLink mobile app (Android and iOS)

Apps for Apple iOS and Android, plus smartwatch apps for viewing RT data

G6 receiver

Apps for Apple iOS and Android, plus smartwatch apps for viewing RT data

G7 receiver?

Transmitter design and on-body form factor

~2 stacked U.S. pennies
(flat disc)

Fully disposable and integrated with sensor patch

~2 stacked quarters
(flat disc)

Fully disposable and integrated with sensor patch

Small eraser-sized

Three-month use transmitter separate from sensor

Fully disposable wearable (integrated sensor/ transmitter), slimmer “nickel-sized”

Insertion and Approved Location

Single-press inserter device with each sensor

Upper arm only

Single-press inserter device with each sensor

Upper arm only

Single-push-button applicator with each sensor

Abdomen (adults)

Abdomen and upper buttocks (children)

Single-push-button applicator with each sensor

Pricing without insurance (one-month supply)

$109

$109

$350

-

In this second table, we’ve compared the key features of the newest standalone CGMs approved in Europe from each of the major CGM companies: Abbott’s FreeStyle Libre 3, Dexcom G6, Medtronic Guardian Sensor 3, and Senseonics’ Eversense XL. The yellow highlight denotes which system(s) has the advantage on a particular category; of course, this is our opinion, and some is subjective!

 

FreeStyle Libre 3

Dexcom G6

Medtronic Guardian 3

Senseonics Eversense XL

Fingerstick Calibration

None – Factory Calibrated 

No optional user calibration in cases of sensor inaccuracy

No sensor calibration code required

None – Factory Calibrated

Each sensor has a unique calibration code – captured via photo

2/day

2/day

Accuracy (MARD)

9.2%

9.0%

~9% (upper arm)
10.6% (abdomen)

8.9%

Labeling

Non-adjunctive – Replaces fingersticks for treatment decisions

Non-adjunctive – Replaces fingersticks for treatment decisions

Adjunctive – requires fingerstick confirmation

Non-adjunctive – Replaces fingersticks for treatment decisions

Population

4+ years

2+ Years

14+ years

18+ years

Warmup

1 hour

2 hours

2 hours

24 hours

Wear length

14 days 

10 days

7 days

180 days

Alarms

Yes – real-time alarms on mobile app

Threshold alerts for highs and lows

Yes – data sent continuously to two display devices – receiver and app

Predictive alerts for lows

Yes – data sent continuously to Apple iOS app

Predictive alerts for highs and lows

Yes – data sent to app and on-body transmitter for vibration alerts

Threshold alerts for highs and lows

Data display

FreeStyle Libre 3 mobile app  (iOS and Android) for viewing real-time data

Apps for Apple iOS and Android, plus smartwatch apps for viewing RT data

G6 receiver

Apple iOS app only; Apple Watch app only mirrors phone notifications

No receiver

Apps for Apple iOS and Android

Transmitter design and on-body form factor

~2 stacked U.S. pennies
(flat disc)

Fully disposable and integrated with sensor patch

Small eraser-sized

Three-month use transmitter separate from sensor

~2.5 stacked quarters (clamshell)

Rechargeable transmitter separate from sensor

Significant on-body tape

~3 silver dollars

Rechargeable transmitter separate from sensor

Insertion and Approved Location

Single-press inserter device with each sensor

Upper arm only

Single-push-button applicator with each sensor

Abdomen (adults)

Abdomen and upper buttocks (children)

Inserter device, requires pulling needle out manually

Abdomen & upper-arm 

Sensor implanted every 90 days

Upper arm

Pricing without insurance (one-month supply)

$109

$350

$345

$99 per 90-day sensor through Eversense Bridge Program

5. Pictures of FreeStyle Libre 3

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