During the TCOYD livestream of their One conference David Ahn, MD said the FDA approved Medtronic’s Simplera CGM. Medtronic and Abbott also announced a partnership.
Medtronic will sell a special version of a Libre CGM that will work with Medtronic pumps according to the Abbott press release.
The Simplera CGM is a one piece sensor similar to an Abbott Libre 3 or Dexcom G7. The FDA approved the device as product code PQF, the same as the Dexcom G5 was. Looking at the summary a couple things stand out:
7 day wear
can’t be used for treatment decisions for the first 12 hours
reading every 5 minutes
no pump integration at this time
…and the correlation with the YSI (lab) glucose values in the submitted clinical trial are not awesome. The trend of the Simplera often reporting a higher number than the YSI does not bode well for use with the 780G.
I keep wanting to compare the clinical trial results to other CGM trials but I know I can’t. CGMs work differently in different people so running a differently designed trial in a different group of people will produce different results. Also all the CGM clinical trials are small, only a couple hundred people each.
This touches on a pet peeve I’ve had about Medtronic for decades.
For a very long time I’ve felt like they did themselves no favors by their commitment to an “ecosystem” business model that constrained them to developing their own, in-house CGM system instead of an “interoperability” model that would have allowed integration with outside developers like Dexcom. Compared with the challenge of creating a wearable system to accurately measure BG in realtime, the insulin pump itself is a relatively straightforward mechanical engineering problem with a bit of control-system programming layered on top. Whereas CGM gets into all kinds of biochemical, hematological, physiological and other areas of scientific specialty, along with UI development and the like. It’s not something you’re going to be able to do very well as a sideline, as amply witnessed by Medtronic’s attempts to do so, first with the Enlite and then Guardian systems. I would probably have stuck with a Medtronic pump if I’d been able to integrate it with the Dexcom CGM.
And in fact, there was a PR a few years back from Dexcom saying they had some commitment from Medt to allow just that. Though the fine print was pretty vague, and since then it’s been crickets. Makes me a little skeptical whether the promise of an Abbot partnership won’t turn out to be vaporware as well, given it’s being announced simultaneously with Medt rolling out yet another iteration of their proprietary system. Meanwhile Tandem has Libre integration in their development stream already and moving forward with implementation.
Nerdabetic had a video about this partnership, mentioning this caveat as well. I hope Medtronic will do the right thing this time. They also shouldn’t sell this custom Abbott sensor at a higher price than regular Libre sensors. I actually don’t understand why they won’t simply develop Libre integration for the regular sensors instead. They just keep clinging to their closed ecosystem thinking.
