FDA approves Medtronic stand-alone CGM

Following recent FDA approval, Medtronic announces that it will offer its Guardian 3 sensor as part of a system that will display on a smartphone. This means people on multiple daily injections (MDI) will be able to incorporate this Med-T CGM as part of their therapy. Check out the details over at DiabetesMine.

Does this interest anyone here?


Thanks for providing the news update. I find this very interesting and will be quite interested in the responses you get to your question:

When I read this, it just seems an odd business decision and I can only wonder what the Medtronic reasoning is behind this.

I don’t follow diabetes business issues close enough to understand Medtronic’s rationale but I think it has some good benefits for them. It enables most* of the MDI cohort to consider the Med-T Guardian and goes head-to-head with Dexcom in this regard. It also permits people to use their CGM while using a competitor’s pump.

I’ve never used any Medtronic sensor but I’ve read many complaints about accuracy and longevity. If I’m to believe user comments, the Guardian 3 sensor seems to be earning widespread respect.

I think the senior decision makers at Medtronic finally feel like they have a sensor system that can compete well with Dexcom. Prior to this development, I always thought that the Medtronic’s prior sensor offerings were only kept alive due to the protection it received as the only sensor that could pair with its pumps.

I also admire their ambition to submit a sensor system to the FDA that talks to a smartphone. I believe the FDA is skittish about this issue but it is the future.

That’s all speculation, of course.

*edited to replace “whole” with “most”.

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That is the thing - it really doesn’t.
It is only FDA approved for 14 years and older.
One assumes it still requires fingerstick calibrations.
One assumes it is not FDA approved to replace fingerstick checks for manual bolus.
Above assumptions mean it will not be eligible for Medicare coverage.

The only things it seems to tout is that this sensor can be used to power a hybrid closed loop as well as the stand-alone sensor provides a 60 minute prediction of a high or low glucose event. Other cgm systems communicate directly to smartphones so that is nothing new.

It is actually hard to imagine somebody using any other (non-Medtronic) pump while at the same time deciding to use the Medtronic cgm. Perhaps that is simply a failure of imagination on my part. I think the big selling point for Medtronic is (and will remain) their pump.

I do find this quite interesting.

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I wonder if there might be an insurance motivation. Perhaps Medtronic is considering giving insurance companies a better deal if they agree to exclusively offer only Medtronic sensors. Now that these sensors are available for people on MDI, insurance companies could require that if a patient needs a cgm, only Medtronic will be covered.

That’s not a particularly exciting idea. Maybe these sensors are on par with Dexcom sensors… seems unlikely though.

This better mean that those of us using Guardians in non-standalone with the 670G will ALSO be able to display our results on our smartphones. The lack of said capability being of the reasons I’m in the process of switching back to Dexcom…

I don’t think so. Same sensor. Different transmitter. Although not being familiar with the Medtronic cgm system, I may have misinterpreted the information.

They are–I’ve worn both, simultaneously. Doesn’t mean there aren’t drawbacks though. The whole insertion process with Guardians is really kludgy (the whole taping thing is ridiculous) and as I said in my other reply, there’s no smartphone app (yet), which is something I really miss.

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While it uses the same Guardian 3 sensor approved for use with the Minimed 670G hybrid closed loop system, this new stand-alone CGM has a different transmitter with built-in Bluetooth Low Energy (aka Bluetooth 4.0). That allows the transmitter to share data directly with a smartphone, notably bypassing the need for a separate dedicated receiver device.

Yeah, I think you’re right. I’m still going back to Dexcom, then, soon as I can get the darn DME order set up.

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As was discussed in another thread, some insurance companies let you choose whether to have it covered under medical as DME or under pharmacy benefits.

On my insurance it makes no difference from a cost perspective but I understand for many insurance plans it can make a substantial out of pocket cost difference.

Certainly worth checking for your own insurance plan.

EDIT: If your insurance will cover the Dexcom as pharmacy and if it is cheaper but your pharmacist does not know how to do it, the following Dexcom webpage may be helpful:

EDIT2: National Drug Codes (NDC)
Dexcom G5 Receiver Kit (Black), NDC: 08627-0080-11
Dexcom G5 Transmitter Kit, NDC: 08627-0014-01
Dexcom G5/G4 Sensor Kit (4 pk), NDC: 08627-0051-04
Dexcom G4 Transmitter Kit, NDC: 08627-0013-01
Dexcom G4 Receiver with Share (Black), NDC: 08627-0050-11

(It would be interesting for somebody to order the G4 Receiver with Share using the NDC under Pharmacy and report back if it turns out to actually be available.)

For whatever reason my BC/BS coverage makes me use a DME distributor for Dexcom but lets me order Guardian stuff direct from Medtronic. Except that I did once get a G5 transmitter prescription filled at Walgreens. The Walgreens was the one in Joslin clinic, so I wasn’t too surprised they actually had it on hand, but I think the pharmacist (a T1 who also used Dexcom) told me they couldn’t do sensors, just transmitters. Go figure. But thanks for the link, I’ll definitely check it out.

That is old news.
The financial situation of Tandem has had a significant turn around.

I am sure certain sales reps from particular companies will still be talking about this old financial news but it is no longer the reality.

February 13, 2018 marked the day. Whether you like the Tandem products or simply enjoy more choice in the insulin pump market, this was excellent news.

So it filed bankruptcy? Saved by the system. :wink:

No. I assume you are in jest.

In any event, the Tandem Diabetes financial statements are a matter of public record.

If you are interested, read the data, the financials and the numbers for yourself. Listen to the online recorded conference calls. Listen to the investor calls. Read the various SEC filings.

None of this is secret information. It is all public. Further, any misleading or fraudulent information in any of this which is put out by the company or its officers would be serious criminal activity which is routinely and vigorously pursued by the SEC.

This is one of the reason I like to read and obtain the information from an investor point of view. It is a Federal criminal action for a company or its officers to lie or mislead investors.

Companies and their marketing and sales teams routinely tell their current and potential customers anything they want with generally little to no consequence.