White Noise

White Noise

Momma Kliff used to say there is real news but more often than not there is more white noise. Something that everyone thinks is a big deal but in reality is much to do about nothing. Our wacky world has been filed with lots of white noise recently so let’s handle them one at a time.

This morning Medtronic announced that their 770g, the follow-on product to the 670g has been cleared by the FDA. Per the company’s press release;

“This latest system by Medtronic expands the benefits of hybrid closed loop therapy to younger children living with type 1 diabetes and makes it easier to access and share real-time CGM and pump data. The system will enable caregivers and care partners to see user data remotely on their smartphones, with proactive in-app notices sent when sugar levels are out of range. The data can also be shared automatically with clinicians and educators to help facilitate more effective telehealth visits and product trainings. This connectivity also gives Medtronic the ability to provide upgrades to future technology via software updates which can further enhance security and device features.”

Is this good news? Yes. Is it a big deal? Somewhat. Will it change the dynamics of the insulin pump market? Nope.

Now we don’t want to rain on Medtronic’s parade but the system for it’s supposed way cool whiz bang has some issues as well the biggest being it works only with the inferior Medtronic CGM sensor, the straw that stirs the hybrid closed loop system drink. We should also note that the Control IQ from Tandem which works with an accurate and reliable Dexcom CGM, already does much of what the 770g does. Therefore as we have stated before Medtronic is not leapfrogging the Control IQ with the 770g it’s merely catching up to the Control IQ.

So kudos to the folks at Medtronic but we wouldn’t be doing the hippie hippie just yet as the Control IQ is still the standard for way cool whiz bang. Heck not sure this news even warrants a happy dance.

Yesterday Mylan and Biocon Biologics made “news” with the US launch of Semglee™, another Lantus knock off. Everyone is making a big deal over how much cheaper Semglee is supposed to be, as if the patient will actually see these savings. (Fat chance on that one.) About the only people happy to see this are of course the payors who now have even more leverage when negotiating with Lilly (who has Basaglar), Novo Nordisk (who has Tresiba) and Sanofi (who yes still has Lantus plus Toujeo). Yep the payors can now say to these established insulin players who are desperate to keep formulary position pay us a higher rebate and give us larger discount or we’ll kick your insulin to the curb. Yep as we say often nothing like bringing a gun to a knife fight.

In more “news” our friends at Abbott via a press release stated;

“Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM),4 announced today its next-generation FreeStyle® Libre 2 integrated continuous glucose monitoring (iCGM) system is now available to Medicare patients. Having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS), the FreeStyle Libre 2 system is now accessible to all Medicare patients with diabetes who meet the eligibility criteria.”

That’s nice too bad that Dexcom has been covered by Medicare as well and that gee patients can make insulin dosing decisions based on the Dexcom data something they cannot do with the Libre2 data. Nor does the Dexcom system come with a host of warnings and/or issues even though it was approved as an iCGM. We’re still trying to figure that one out.

Now we’re sure if this is “news” or not but we’re hearing that things aren’t going so well at Tidepool. Yes this non-profit which used to push the edge of the envelope with its focus on interoperability is having financial issues. Listen non-profit or not the organization still needs money to operate. The question is and the problem we think they are running into is has this organization outlived its original mission.

Years ago when Tidepool began it was rare for all the toys to talk with all the other toys. Today that isn’t just commonplace but a requirement. The Control IQ, 770g, 670g and the coming OmniPod 5/Horizon or whatever it’s called (and damn can’t these companies pick a name for their toy and stick with it) have made interoperability mute. And let’s be very honest why would any Medtronic CGM user want to share their data with another device as the sensor sucks to begin with.

Nearly every Tyler under design communicates with either the Dexcom Libre or both. (Perhaps one day they will also communicate with the Libre2 assuming of course Libre2 ever gets approved for use with automated insulin dosing systems. And this got an iCGM designation why?)

To be very clear here we do not wish any ill to come of the very dedicated people at Tidepool who should be given tons of credit for what they accomplished. The same can said about the good people at NightScout or the OmniPod loopers. However these we want it yesterday folks need to realize that yesterday has come and will soon be gone. That the capitalist for profit businesses that they rallied against have seen the light. That these for-profit entities using their resources have developed some pretty cool systems of their own.

Perhaps it’s time for these organizations to refocus and join the for-profit companies in the quest to make diabetes management for insulin using patients as easy as making a peanut butter and jelly sandwich. Interoperability is HERE, advanced insulin dosing algorithms are HERE, hybrid closed insulin delivery systems are HERE and Tyler is coming very soon. The most popular CGM systems are already talking to all the other toys and one day perhaps the newest of these will have the ability to work with AID systems.

There are now a plethora of apps which take all this data, analyze it and make recommendations to the patient on how they can more effectively manage their diabetes. And more are on the way.

Yet just as for-profit entities refocus due to changing technology and market dynamics so to should not for profit entities. There is no shame in this. This is not admitting defeat. This is called adapting, surviving and even thriving. These not for profit who rallied against the pigheadedness, conservative, move at glacial speed for profit companies should not become what they at one time decreed. Your voice is still needed but it cannot be the same voice it was when you first started singing. It’s time to sing a different tune or that fat lady will be singing your swan song.

Now if you want real news take a look at what’s happening here in Chicago with my beloved White Sox and the boys in blue on the north side are both in FIRST PLACE. That’s not just real news but cause for a major happy dance. A cross town World Series? We’ll break out the hippie hippie for that one.