No Need For This

No Need For This

Now that we have had some time to review the FDA’s recent decision to approve the Libre2 we still have more questions than we do have answers. Such as why did it earn an iCGM designation when it cannot be used with an automated insulin delivery system? Why is Abbott who should be happy to have this approval igoing around trying to discredit Dexcom falsely claiming Libre2 is somehow better than the G6.

Let’s start with iCGM which according to the FDA means;

“An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.”

Now look at the WARNING that came with the Libre2 approval;

“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.”

Now it seems to us anyway that it’s fairly useless to send data to any device when the data being sent cannot be used in the decision-making process. Which makes us wonder why the FDA gave Libre2 the iCGM designation. Yes it can talk to other devices but using the FDA’s own definition we’re not sure how this data is being used “for the purpose of managing a disease or condition related to glycemic control.”

Then again we have never really figured out why the FDA called the Libre or Libre2 a CGM in the first place – CGM stands for Continuous Glucose Measurement something neither the Libre or Libre2 does as readings are only delivered when the patient scans the sensor, unlike the Dexcom system which CONTINUOUSLY delivers readings to the app or receiver, just saying.

What we really don’t understand is why Abbott is telling analysts that Libre2 is better than the G6. Listen we’ve seen the data, the charts and other stuff they have sent, and we just don’t get it. We have also read the study data for Libre2. What is Abbott upset that shares of Dexcom went UP on the news of the Libre2 approval? Are they pissed that Libre2 cannot be used with a Tyler or insulin pump? Does it bother them that when the G6 was approved for use with the Control IQ it didn’t require a study. Listen anyone who claims Abbott just needs to do additional studies so it can used with AID is kidding themselves. The fact is if a system meets the iCGM standard you don’t need to do an AID trial.

The facts are these the Libre2 is somewhat of an improvement over the Libre. It is not however as robust of a system as the G6. It cannot be used to make dosing decisions and as configured today would be of little value even if it did send data to a connected pen or insulin pump.

Yet most importantly all this noise by Abbott is just that noise as it will not change their strategy. Abbott has made it crystal clear they intend to pursue a value strategy with Libre/Libre2. Get as many of these suckers on as many patients as possible and we see nothing wrong with this approach. As we have said before Libre has exceeded all expectations and does a good job. The system has some known issues but even with these issues does a fine job. This is what makes Abbott’s actions seem petty.

Not like we need to say this again but CGM is becoming the standard for glucose measurement. The market is growing like a weed and is large enough growing fast enough for both Abbott and Dexcom to win, which they are as between the two of them they own 95% of the market. Neither company is facing a serious competitive threat, and both have lots of room to grow even larger.

Frankly the behind the scenes actions taken by Abbott makes us wonder if there is more to this story as it makes no sense. They got what they wanted FDA approval with iCGM, they should be jumping for joy not crying in their beer. They should be taking the high road and acknowledge this approval is a good thing for all patients with diabetes. Instead they are going behind the scenes trying to discredit their main competitor who has the facts on their side. They are using suspect data which when examined by the trained eye looks hollow and quite frankly childish.

Abbott should be better than this, there is no need for these stupid shenanigans. As Momma Kliff said the goal is to win the game. This is not like Game of Thrones where winning means totally annihilating your opponents. This is supposed to be about patients with diabetes what’s best for them. Abbott claims this is what they are all about unfortunately their actions don’t march their words.