Upon further review

Upon further review

One of the more maddening things about football these days is the use of instant replay. Nothing is more irritating when your team scores a touchdown and the next thing you hear is “This play is under review”. Then for what seems like an eternity the officials and play by play broadcasters look at three hundred different camera angles trying to determine whether you should cheer all over or boo the officials for robbing your team of what was obviously a touchdown.

Then after every angle has been looked at using ultra slow motion and every other way cool whiz bang toy known to man the official stands before the TV camera and utters; “Upon further review…….”

Well we’re wondering if the people at Abbott feel that upon further review the FDA’s approval of the Libre2 isn’t the touchdown they thought it was. At first glance it appeared the company got what they wanted including the iCGM designation. The press release states among other things;

“The FreeStyle Libre 2 system met or exceeded the FDA’s rigorous iCGM special control standards. The system is designed to digitally connect and communicate with other devices. This can allow people to tailor and potentially simplify how they manage their diabetes.”

Everything seemed normal for as we anticipated once the news broke shares of Dexcom began to sell off although not as much as we thought they would. Then in a strange about face at around 10am EST Dexcom began a dramatic reversal and began rising hitting an intraday high of $399.54 and closing at $398.75 up some 7.70%. So just what created this turnaround?

Well upon further review the devil is in the details and buried at the end of the Abbott press release under the heading Warnings/Limitations is the following fine print;

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions.” – note we added the color and highlighting

That first sentence is a stunner and somewhat incongruent with an iCGM designation. Not to be used with AID including closed loop or insulin suspend systems. The last sentence is also confusing as isn’t the damn thing supposed to alarm before a patient goes low or as they go higher. If the damn thing is accurate as they say it is why does the patient have to confirm these readings with fingerstick, which by the way has a nice margin for error so it isn’t all that accurate either. Yes we know this convoluted using a BGM system which isn’t all that accuarte to begin with to confirm a reading on a CGM which claims to be accurate but lets not go there but this may explain why my hair continues to get grayer by the day.

This warning is also bad news for the folks at Bigfoot whose Unity system is supposed to work with the Libre2 and eventually help the patient make more informed insulin dosing decisions. That’s assuming of course the Unity eventually does more than just tell the patient something they already knew namely they have just taken an insulin injection. We’re still trying to figure that one out but let’s not digress as it will only make our hair grayer and right now we like the salt and pepper look.

Anyway even if it did measure the actual dose of insulin taken this warning indicates any dosing recommendation made using the glucose data provided by the Libre2 is basically worthless. For what is the Unity supposed to be but an automated insulin dosing system or as we like to call them a Tyler.

This warning also means that Abbott cannot invade Dexcom’s turf and go after Tandem or Insulet. Yes Tandem and Insulet have both indicated a willingness to work with Abbott but now this isn’t possible.

So upon further review this approval is just one big yawn and not the touchdown Abbott and many others thought it would be. No wonder the folks in San Diego are cheering as are their stakeholders. Abbott didn’t score today Dexcom did.