Just in case you forgot, Medtronic Diabetes does in fact have a stand-alone continuous glucose monitor (CGM) on the market.
The Medtronic Guardian Connect was FDA-approved and launched last Spring, and rolled out over the latter months of 2018. But not many in the D-Community had been talking about it much because, well... Medtronic really hadn't been doing that either. Until now, when they've come forward with bold messaging around how this device can improve outcomes for people with diabetes.
The company didn't promote this product -- its first stand-alone CGM since its "Real-Time" product back in 2007 -- at anywhere near the level of publicity for their full Medtronic Minimed 670G hybrid closed loop. That system uses the same CGM sensor connected to a Medtronic insulin pump with an algorithm that auto-regulates insulin dosing to keep blood sugars in range.
While Medtronic is the long-time market leader in insulin pumps, the Guardian Connect was meant to expand their customer base by offering a CGM option to PWDs (people with diabetes) who don't wish to use a pump. It is a direct competitor to other CGMs on the market, including the popular Dexcom G6, the Abbott Freestyle Libre Flash Glucose Monitor, and the newest Eversense implantable three-month CGM from Senseonics.
Still, the company's been awfully quiet about it, until recently, when their diabetes division began posting more ads and news bits about the stand-alone CGM. It was part of the news in early April, when headlines hit that Medtronic had entered into a "value-based outcomes agreement" with Blue Cross Blue Shield of Minnesota, where Medtronic's US headquarters is based.
Measuring Diabetes Outcomes via "Time in Range"
That Blue Shield deal allows members with diabetes to get the Guardian Connect CGM as a "pharmacy benefit," which makes it easier to access and more affordable. But what's really unique is that the two organizations have agreed to use a metric other than the gold standard A1C test to measure members' success using this device. Diabetes advocates and innovators have been pushing to move "beyond A1C" for a number of years now.
A Medtronic spokeswoman tells us proudly that Guardian Connect becomes the first-ever stand-alone CGM using "Time in Range" as the key metric. Their press release explains:
"Time in Range (TIR) is a standard measurement in diabetes management that tracks the amount of time a person’s glucose is in their target range with 70-180 mg/dL being the standard range. Spending more Time in Range helps minimize both short- and long-term health complicationsfrom going too high or low. Results from an analysis of people who used the predictive alerts feature on the Guardian Connect system showed that they experienced fewer high events 39 percent of the time (vs. 10% without alerts) and fewer low events 60% of the time (vs. 33% without alerts)."
Medtronic has also been promoting a TIR infographic:
With Blue Cross Blue Shield, they are actually tying insurance payments to the amount of time users spend in this healthy glucose range -- an approach known as "value-based payments." So if a Medtronic CGM user does not manage to stay in that ideal 70-180 mg/dL range for a certain amount of time when using the device, then Medtronic will actually pay back the cost to the insurance company.
Just how much time must be spent in range?
"We have not publicly disclosed the Time in Range levels outlined in the agreement," Medtronic Diabetes Communications Program Manager Kendra Cassillo told us via email. Hmmm...
Wins and Losses for Medtronic Diabetes
A big win for Medtronic here is that they come out looking like a champion (and even innovator?) of the Time In Range metric and moving Beyond A1C. They're also at the forefront of moving to value-based payments that link insurance coverage directly to patients' health results.
Yes, Medtronic Diabetes has done something similar before, with a 2017 deal guaranteeing they would pay back treatment costs for patients who did not do well using their Minimed 670G. However, that was aimed at covering emergency-related and hospitalization costs in extreme cases of hypoglycemia or DKA. This latest TIR agreement illustrates that they are also willing to stick their neck out to guarantee success in the daily D-management of eligible BCBS-MN members using Medtronic's Guardian Connect.
Medtronic has also introduced a new "gamified" incentive program for BCBS-MN members using either the stand-alone CGM or 670G system, called Inner Circle that awards users points for the time they spend in the target range. This is certainly an interesting experiment on Medtronic's part. (More details on that below).
On the downside, many have criticized Medtronic for making exclusive agreements with other insurance carriers that may unfairly push their products and restrict patient choice. Specifically, the United Healthcare (UHC) deal granting "preferred" status to Medtronic device users that was first announced in May 2016 for adults, and expanded in 2018 for kids and teens. That is specific to the Minimed 670G, and we've heard countless stories from the D-community where patients are being told that non-Medtronic devices are not covered at all, despite UHC's official word that an appeal process is in place to allow members to gain access to other insulin pump brands.
About the Medtronic Guardian Connect CGM
As a refresher, here are the basics on the Guardian Connect stand-alone CGM:
Different Transmitter: The meat of this system is a new transmitter, that has the same seashell-shape design as other Medtronic CGM models but has Bluetooth Low Energy built in. That allows it to beam glucose data directly to the smartphone every five minutes. The transmitter has a 12-month warranty and is rechargeable. It costs $620 cash-price.
Same Sensor: Yes, this system uses the same Guardian 3 sensor that goes with the Minimed 670G here in the US (while internationally, the stand-alone CGM uses an older-generation MedT sensor). The Guardian 3 sensor is approved for seven days of wear, and most recently in February 2018, it was FDA-cleared for wear on the upper arm along with the abdomen. A box of five sensors costs $345 at cash-price (with a 20% discount applied for cash purchases).
Not Pump-Connected: As a result of the above-mentioned change in the transmitter, this system doesn't connect with Minimed insulin pumps. Medtronic is working to develop next-generation versions of its 630G and 670G devices that will have built-in BLE and allow for direct data-sharing, but as of now we're told that is not expected until roughly the end of March 2020.
CGM App: The Guardian Connect mobile app is free, though it's only available for iOS users right now. An Android version of the mobile app is in development, but timing’s still TBD.
Touchscreen: In true iPhone form, you can use your finger to trace CGM data lines, and expand or contract the view of glucose results for whatever period of time you're looking at.
Customizable Alerts: Users can set the predictive alert for any timeframe they wish, from 10 minutes to 60 minutes in advance of a predicted low or high blood sugar. You can also program different glucose thresholds and alerts for different times of day (i.e. Day vs. Night, or any other two periods of the user’s choosing).
Sugar.IQ App: This is a separate mobile app that Guardian Connect CGM’ers have “exclusive access” to. It’s the IBM Watson app that Medtronic’s been talking about for a few years now and launched to a small beta-testing group in Fall 2017. The app uses IBM Watson analytics to find patterns in diabetes data and offers real-time, actionable and personalized insights, which includes a circular graph reflecting TIR data and a "Glycemic Assistant" with food info. Results from its 250-person limited preview program at the ADA Scientific Sessions in 2017 showed 60% were using the app more than once a day, with TIR increasing 2.6% on average and fewer hypos as a result of the mobile app use. Sugar.IQ will pull info from Medtronic's Carelink platform.
Inner Circle Gamification: First launched in August 2018, this app uses gamification principles to encourage behavior changes that help PWDs achieve better outcomes, focused on Time In Range as well as "personalized challenges." There's also a community forum weaved into it to let users share their tracked progress. As part of the new BCBS-MN agreement, users who take part in the Inner Circle program can earn up to $300 a year to offset the cost of their CGM and sensors.
Medicare Coverage for Medtronic's CGM?
We also asked Medtronic where it stands in pursuing Medicare coverage for its Guardian 3 CGM. Spokes-folks tell us the company expects to file a "non-adjunctive designation claim" with the FDA in the next few months. That means if OK'd by regulators, the sensor would be approved for use in making dosing and treatment decisions, without the need for a glucose fingerstick test to verify results.
Dexcom was first to get this vote of confidence, followed by Abbott Libre, and Medicare officials have now stated that this "dosing claim" is their criteria for allowing a CGM to be considered valid for coverage.
These are great updates to hear, though we are cautiously optimistic whenever it comes to anything related to Medtronic. Investor analysts point out that the company has been known to over-promise and under-deliver at times, particularly as it relates to timelines or next-gen product iterations.
Their 670G system and stand-alone Guardian Connect seem to be working out well for some in the D-community, based on what we read and hear, but there is still a large gap many point to when it comes to performance versus other CGMs on the market.