And the wackiness continues

And the wackiness continues

One of the benefits of having been around the block more than a few times is that rarely are you surprised by any turn of events no matter how strange they appear to be on the surface. Yesterday while repenting our sins we came across a few items of interest. The first was the following;

Per a post on the Fierce Pharma web site; “Novo Nordisk is partnering with the American College of Cardiology (ACC) in a two-year, two-pronged initiative. First, the partners will study real-world data to determine patterns and adherence to guidelines. Next, they’ll explore how to help Type 2 patients improve their heart health, working through ACC clinicians and healthcare providers, Novo Chief Medical Officer Todd Hobbs said.”

Now there may be some who have forgotten about one of our dear friends who was also repenting his sins yesterday that crusading cardiologist Dr. Steven Nissan. Yes years back the good doctor with the help of Congress created the Avandia controversy. A mega-blockbuster drug which GlaxoSmithKline pulled from the market thanks to the concerns raised by the good doctor. Concerns which were centered on a now infamous meta-analysis which was later reputed but not until after the damage had been inflicted.

The irony here is that thanks to the good doctor the FDA changed the way they approved diabetes drugs making companies run extensive cardiovascular studies. It was no longer good enough to control glucose or lower HbA1c drugs now had to prove there were no adverse cardiovascular events associated with their use. Although the drug companies initially complained long and loud about these new guidelines it turns out that low and behold several diabetes therapies have produced cardiovascular benefits that are now touted by the same companies who complained in the past.

So as it turns out while the good doctor may have been proven wrong about Avandia he did in his own way help all the drug companies find more ways to promote their drugs. As Momma Kliff used to say sometimes you can be right and wrong at the same time.

The next bit of news which caught our eye was this from our friends at Abbott;

“Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM) technology,8 announced today it has secured CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe. The FreeStyle Libre 3 technology provides continuous, real-time glucose readings automatically delivered to smartphones2 every minute, offering unsurpassed 14-day accuracy1 in the smallest and thinnest3 sensor design at the same affordable price7 as previous versions of the device.”

Now the release does not state, nor do we know if the Libre 3 can be used with automated insulin dosing systems. Nor does it state when or if the Libre 3 will be submitted to the FDA for approval. On the later point our educated guess is they need to get Libre 2 approved for AID with the FDA before submitting Libre 3 to the FDA.

The Libre 3 looks at a lot like the Dexcom G7 and seems to share many of the characteristics of the G7 notably the much lower profile of the sensor plus a simple easy to use insertion device.

Here are our takeaways from this news;

1. Abbott and Dexcom continue to own the CGM universe.

2. Life continues to get more difficult for every Dexcom wannabe.

3. Abbott is firmly committed to their value strategy with Libre.

4. Dexcom sales will not be adversely impacted by the Libre 3.

5. Abbott continues to be more aggressive in international markets with Dexcom more aggressive domestically.

6. These continual improvements in CGM technology combined with greater affordability only reinforces the fact that CGM is now the standard for glucose measurement.

Besides all the Dexcom wannabes the real losers here are all the old fashioned BGM companies who better accelerate their plans to find new toys to sell before CGM completely takes over the glucose monitoring world. These include all the diabetes coaching platforms that are based on old fashioned finger stick BGM systems. Just how long OneDrop or Livongo can survive using old fashioned systems is anyone’s guess as Onduo is about the only diabetes coaching platform that uses CGM.

Just one more reason we are astonished that Teladoc valued Livongo at a whopping $18.5 Billion. Let’s be honest but all the way cool whiz bang in the world that Livongo supposedly has is not worth anywhere close to $18.5 Billion and we don’t care how many deals Livongo makes or how many other chronic disease states they have besides diabetes. Just as CGM is the straw that stirs the hybrid closed loop insulin delivery drink, diabetes coaching is the straw that stirs the Livongo cocktail.

As a side note with each advancement in CGM technology it becomes more likely that Time in Range (TIR) will be used along with HbA1c as tools for measuring control. We are not far from the day when these two metrics will be used together to define what is and what is not good control. This transition has begun already in some more advanced circles.