No longer unique

With CES beginning next week other than reading stupid useless studies we’ve been prepping for the show trying to get some advance legwork done. Anyone who has been to CES knows this is one crazy show and there is no way to see it all. It is not an overstatement to say that CES literally takes over Sin City occupying nearly every inch of convention space.

While doing this advanced legwork it dawned on us that patients with diabetes are no longer unique in one respect. With the explosion of wearable devices patients with diabetes are no longer the only people walking around with a plethora of devices attached to their bodies. There are so many wearables that we suspect the next step in the evolution of these devices is wearables that measure more than one thing.

Yet one wearable that may or not be at CES or JPM the following week is the Libre2 from Abbott. Keep in mind Abbott will be at CES and also presenting at JPM the following Tuesday morning. One would think that now that the FDA has finally approved the Control IQ, which took way longer than necessary they would move onto the Libre2. Should there be no news between now and Tuesday the 14th you can bet the farm Abbott will face more than one question on just what the holdup is with Libre2.

There is no question that Abbott has learned from the many mistakes they made when Navigator was their CGM. However here with Libre2 they may have fallen back to their old ways. Based on everything we have learned and everything that’s in the public domain the Libre2 is an improvement over the Libre. However the misstep here might be Abbott insistence for an iCGM designation. This insistence is costing the company valuable time and allowing Dexcom to get their G7 to the FDA.

While it’s too late now we don’t understand why Abbott coveted iCGM when having it or not won’t change their strategy one bite. Again based on what we know and what has been said publicly the FDA isn’t convinced Libre2 is worthy of iCGM. That had Abbott not asked for iCGM and perhaps gone for that latter Libre2 would be here already. The issue as we understand it appears to be in the hypoglycemic area which is a known issue with Libre.

Let’s be very clear here the Libre and Libre2 are fine sensors that do an excellent job. However the Dexcom G6 has proven to be a more robust sensor with greater accuracy throughout the range of glycemic readings. We have found it somewhat funny when clinicians and/or patients debate the differences between these two very good systems. This is like debating who’s a better quarterback Joe Montana or Tom Brady. Still this debate goes on, but the fact is either system works well enough in 95% of patient situations.

This makes Abbott insistence on iCGM even stranger as they have proven with Libre that their value strategy works and has worked very well. But they have committed to iCGM and cannot go backwards as this would create a public relations nightmare. It would be wise to search the Diabetic Investor archives searching Navigator as this is not Abbott’s first rodeo with CGM and regulatory missteps. While we can’t say history is exactly repeating itself there are some uncomfortable similarities. In their public statements the company has gone from extreme confidence to extreme caution. Not a healthy sign by any means.

The reality is iCGM matters only to select few and not to the masses. However since Abbott has made a big deal out of iCGM it could come back to haunt them. Way back in the day when SMBG ruled the glucose monitoring world LifeScan in stroke of marketing genius made test stripe accuracy a major issue. Again something that’s searchable in the archives, but to sum it up LifeScan played offense forcing everyone else to play defense. The issue they raised was minor but seemed major and they won the all-important PR war.

This same situation could happen with Libre2 as let’s say Abbott capitulates to the FDA and says hey, we don’t need iCGM right now please approve the sensor without iCGM. Dexcom would immediately capitalize as they could accurately note they have iCGM and Abbott doesn’t. Again it really does not matter whether the patients or physicians actually care about iCGM or even know what it is, what matters is in the diabetes toy world one company has it and the other doesn’t. The implication being that the product with iCGM is superior.

Hence the reason Abbott seems to be toughing it out with the FDA as they cannot afford to reverse course now. They have been very public about getting iCGM and now this insistence appears to be costing them valuable time having Libre2 on the market. How costly of an error is this? Frankly we aren’t sure until the G7 and Libre2 go head to head. Yet this delay in getting Libre2 approved is eating up time and allowing Dexcom the time to get the G7 to the FDA.

Let’s just hope that Abbott hasn’t fallen back to their Navigator ways.