A change in Bigfoot’s plans was announced today. Dexcom out, Freestyle Libre in, revised timeline to market.
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This is an interesting development. It makes sense due to the geographic proximity of these two players. The Abbott Diabetes Care Division is located in Alameda (near Oakland in the SF Bay Area) while Bigfoot’s headquarters are in Milpitas, the South Bay. Bigfoot took over the offices of Snap, a failed insulin pump manufacturer.
CMS, the organization that manages Medicare and Medicaid (US) has delayed the introduction of payment for Medicare recipients in part due to its requirement that the Dexcom G5 needs to be bundled as a kit with everything needed to use this CGM, including the BG meter and test strips for the required calibration.
This may have motivated Bigfoot, in part, to choose to partner with the “no calibration” BG sensing system created by Abbott. For Medicare coverage, I would think that Abbott’s Freestyle Libre system would need the FDA’s blessing as a system that may be used for treatment decisions without a confirmatory fingerstick.
I didn’t read any indications as to the timeline for introduction for this tech but it’s likely a few years off. The Abbott sensor that Bigfoot wants to use will be one that Abbott has not yet introduced. I have no idea where this new sensor is in the formal study/trial process.
I’m happy to see a third player in the blood glucose sensor market. Many people with diabetes loved the Abbott glucose sensor product that the company withdrew from the US market many years ago.
Yes. The Navigator. At the time, that was known to have better accuracy than Dexcom, but a huge profile. Should Libre be assumed to have the same performance simply bc they are both Abbott products? Or is it known that the use the same technology? And Dexcom has come a long way in accuracy since then, so comparing Seven Plus performance to Navigator to conclude on Libre’s accuracy - I’m finding that a hard path to take. I know you aren’t suggesting that. It’s something being hinted to elsewhere.
I don’t know that much about any shared tech between the Navigator and the Libre. It would only make sense that Abbott would have used its experience with the Navigator to inform its effort with the Libre. But that does not have to be the case. They might have started on any entirely separate path.
I don’t have any direct experience with the Libre so I don’t know first-hand about its accuracy or precision. Have you seen any references that compare the MARD (statistical accuracy measure) numbers of the Libre to the Dex?
No. Just personal testimonials of experience.
Actually the pump was called Snap; the company was Asante. And as I understand it they took over the Snap design itself as the basis for their own pump development. As one of those who used the Snap before it cratered I’ve had a hopeful eye on Bigfoot for some time. But increasingly I get the impression there may be no “there” there. Lot of interesting stuff in terms of philosophy, innovative business model, etc., not so much in terms of actual prototype development so far as I can tell. This seems like it’s likely to extend the timeline for actually producing a purchasable product.
Oh fer the luv a… Hadn’t heard this before. I mean, I guess I can see where if you’re certifying the CGM, the CGM has to be calibrated against a separate BG meter system, and the meter systems out there vary widely in accuracy, it sorta kinda makes sense that there should be the One Officially Sanctioned BG Meter. And if there is then a OOSBM it makes sense that it should be bundled with the CGM itself. But given that everyone has been using the BGM of their choice for–what, a decade or thereabouts?–to calibrate these things and the FDA has been fine with it, to the extent of ok’ing bolus decisions based on Dexcom readings, this just seems really dumb.
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The FDA is not getting involved in this aspect. It is a distribution issue. It has recently been posted on here (somewhere) that Dexcom has now gotten this worked out.
Dexcom appears to be taking on the distribution of their Medicare-payment-approved G5 kit as an in-house activity. I never liked, once I became eligible for Medicare, I was prevented from continuing my supply purchase directly from the manufacturers and forced to do business with a Medicare approved third-party. In this respect, I like this development but it comes a a cost to people who need the Medicare paid-for product now, not some vague date in the future.
I follow Bigfoot with great interest. Not sure I like this decision because it seems likely to delay their commercial launch by a good 6 months or more. I guess Abbott sensors will allow Bigfoot to offer a no calibration system from the start but Dexcom is strong in its manufacturing capability and relationship with FDA. Hmmm. Fingers crossed that Abbott gets a transmitter designed and rolled out smoothly and the delay is minimal!
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As much as I like the idea of no-calibration, I worry about this… I was a big fan of the Snap pump, am a big fan of Dexcom. Abbott has been going slow on getting approval for the Libre for patient use, so this deal concerns me.
Am I the only one?
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You are not.
Makes you wonder if the $$$ made it hard for Bigfoot to pass on. Personally, I would suspect the long term ownership picture of Bigfoot will be quite different than today.
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@Thas, my other Snap buddy! Not sure if we’re the only ones around here…
Like I said in my overlong post above that at the least it seems like it’s going to extend the development time line (is there one?) and increases my feeling that this may be vaporware.
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