One of the longest-running companies involved in diabetes technology is Medtronic Diabetes, which has had a twisting pathway in its product pipeline over the years.
The company has been the leader in insulin pumps dating back decades and was the first to launch a combo device with a continuous glucose monitor (CGM). As a powerful Pharma industry leader, patients tend to have a love-hate relationship with this company — appreciating their offerings but not always their customer service or marketing tactics.
No matter how you slice it, Medtronic Diabetes does help lead the way in diabetes technology, so it’s important to know what the company is up to. Here’s a deep dive into what Medtronic Diabetes is offering in 2020 and beyond:
As of mid-2020, here is what Medtronic Diabetes offers as to tech tools:
Minimed 670G (Hybrid Closed Loop)
The Minimed 670G was a first for our Diabetes Community, with this early Hybrid Closed Loop (HCL) snagging the Food and Drug Administration’s (FDA) approval in September 2016.
“Hybrid Closed Loop” really just means the insulin delivery system is partially automated but still requires some control by the user. The official FDA definition gets a little more technical.
The way it functions is that the CGM sensor reads glucose data every 5 minutes, and the “closed loop” algorithm built into the pump uses that information to increase or decrease basal (background) insulin delivery to keep glucose levels as close as possible to a fixed target of 120 mg/dL (to many users’ dismay, this level can’t be adjusted).
Users still need to enter carb counts and bolus amounts to cover meals, and alert the system in advance of any exercise. It also does not give automatic correction boluses based on CGM, but it does suggest correction amounts when a fingerstick glucose result is entered.
The 670G launched in 2017 to high expectations, but being an early and still-limited “Artificial Pancreas” with some clear limitations, it didn’t get as strong a positive reaction from people with diabetes as the company had hoped.
Smart insulin pen: Companion’s InPen
In August 2020, Medtronic Diabetes announced it was acquiring Companion Medical’s startup and the Bluetooth-enabled insulin pen, known as the InPen. This is the only FDA-cleared reusable insulin pen that connects with an app to track data and gives users personalized dosing recommendations for short-acting insulin (Humalog, Novolog, Fiasp).
Before now, insulin pumps have been Medtronic’s only delivery method offered to patients; but now by buying its way into the smart insulin pen market, there will be a new option for those who choose injections rather than pump therapy.
Medtronic says it does not plan to change the InPen’s ability to connect with CGMs like the Dexcom and Eversense implantable CGM, and it also plans to build in connectivity for Medtronic’s Guardian CGM in the future.
Guardian Connect CGM
Guardian Connect is the name of Medtronic’s stand-alone CGM device, which has been available since March 2018 and doesn’t need to be paired with an insulin pump in order to work. The Guardian Connect was the company’s first new stand-alone CGM product offered in a decade.
Unlike the 670G system that does not offer any data-sharing or remote monitoring, this stand-alone CGM does offer built-in Bluetooth Low Energy for data-sharing directly with a smartphone. It uses the same Guardian 3 sensor approved for use with the 670G, and notably, it bypasses the need for a separate dedicated receiver device to view data.
This is not calibration-free, which is different from competing CGM products (Dexcom G5 and G6 versions and the FreeStyle Libre) that don’t require fingerstick confirmations before any treatment or insulin dosing. It’s also only approved for use in ages 14 and up, meaning children can only get this product if a physician is willing to prescribe it “off-label.”
Guardian Connect mobile app
At the time of launch, this free app was only available for iOS users. But in May 2020, Medtronic announced FDA approval for its Android version starting in the summer. It also now offers updates to some pretty cool snooze and personalization features for tracking and managing blood sugar, which you can read about here.
Sugar.IQ mobile app
This is a separate mobile app that Guardian Connect CGM users have exclusive access to as well. It’s the original IBM Watson app that Medtronic acquired and hyped before eventually launching it to a limited number of customers using their stand-alone CGM in 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 time-in-range (TIR) data and a so-called “Glycemic Assist” for food info. Medtronic has presented scientific data showing that people using the Guardian Connect system with the Sugar.IQ app experienced 4.1 percent more TIR compared to using Guardian Connect alone — representing about one extra hour per day. Additionally, those who also used the optional Glycemic Assist feature to review their response to specific foods increased TIR by an additional 4 percent compared to those not using that feature.
Under new leadership since October 2019, the Medtronic Diabetes division dropped a few exciting details of its upcoming tech pipeline going into the big American Diabetes Association (ADA) conference in June 2020:
Advanced Hybrid Closed Loop (780G)
First previewed around the ADA Scientific Sessions in June 2019, the company’s 780G next-gen Advanced Hybrid Closed Loop (ACHL) system will have the basic form factor of their 6-series model insulin pumps. That means a vertical “modern” look, compared to the older models with a horizontal design that resemble 1980’s pagers.
Some key features of the 780G we’ve learned about:
- uses a new algorithm the company says is more accurate and reliable, developed as a result of the partnership with Israel-based DreaMed Diabetes announced in 2015.
- works with the next-generation Zeus CGM sensor, which will have only 1 calibration on the first day and won’t require fingersticks after that.
- will provide automatic correction bolus every 5 minutes to help keep users in an optimal range, and to automatically adjust for missed meals.
- has an adjustable glucose target between 100 to 120 mg/dL (compared to the 670G’s fixed target at 120 mg/dL).
- offers different insulin duration times, unlike other commercial closed loop systems available.
- offers built-in Bluetooth necessary for data-sharing and remote monitoring, as well as over-the-air remote software updates so users won’t be required to buy a whole new device every time new features are launched. (Currently, only the Tandem t:slim X2 offers that remote updating capability).
- Medtronic plans to ask regulators to OK this new system for adults AND kids as young as 2 right from the start.
At the ADA Sci Sessions in June 2020, Medtronic released important pivotal trial data for this upcoming 780G system, showing better TIR outcomes and impressive user satisfaction marks for the system’s usability.
This system now has CE Mark approval overseas, and the company is gearing up for filing 780G with the FDA here in the U.S. soon.
Medtronic received FDA clearance on Aug. 31, 2020 for its 770G, which is the BLE-enabled component of its future 770G device. This is viewed as a stopgap between the existing 670G and the future 780G, adding in Bluetooth connectivity for data-sharing and remote monitoring (something competing devices like Dexcom have offered for years). Notably, it’s available for kids younger than 6 years old and as young as 2.
Medtronic is launching the 770G first as a separate device, prior to the eventual release of the full-featured 780G. The company notes that customers will be able to easily upgrade to 780G and newer features remotely, rather than requiring a new hardware purchase (similar to what Tandem’s offered with its remote-updating capability in t:slim X2).
Extended-wear infusion set
Medtronic recently presented data on its 7-day infusion set, which can be worn twice as long as current sets that are okayed for a max of 3 days. A U.S. pivotal trial is ongoing and this new infusion set is already approved in Europe.
In news releases, Medtronic points to a “novel and proprietary approach” that addresses insulin degradation and preservative loss — two things that can result in occlusions (insulin clogs in pump tubing) and thus higher blood sugars. Along with maintaining insulin stability for the full 7 days, it will also use a new adhesive technology to help ensure it stays stuck on the body for that full wear-time.
Early clinical data shows that people using this new set might save 5 to 10 vials of insulin per year that are currently wasted due to the requirement to change the set every 3 days. Less-frequent set changes would also allow for other skin site locations to rest and heal, Medtronic points out.
We are reminded, however, that infusion sets have been described as the “Achilles heel” of modern insulin pump technology because they tend to have many weaknesses. Medtronic especially doesn’t have the most successful track record in this area. Remember the BD FlowSmart technology that was launched as the Medtronic Pro set? That didn’t last long, as reports of kinked cannulas led to the initial product being pulled from the market by Medtronic. The company worked with BD to study the problems and planned to re-launch this infusion set, but eventually BD scrapped the concept completely.
Future CGM sensors
Medtronic is also developing its next-generation CGM sensors, stepping up the game from its original Enlite sensors and current Guardian 3 version that comes along with the Minimed 670G and stand-alone CGM. The company has hinted at future CGMs for years in scientific presentations, but haven’t been publicly discussed much until mid-2020.
For now, the two new models are both known by internal project names that likely won’t be the final brand names:
- Project Zeus sensor: would still have a 7-day wear and the same seashell design, but it would be an “iCGM” classification (FDA-cleared to integrate with other devices) and would require fingerstick calibrations only on the first day of use.
- Project Synergy: an all-in-one sensor/transmitter that will be fully disposable and have a new look. With a flatter, square form factor 50 percent smaller than the current model, it will not require any overtape to keep it on, and will have a simpler three-step insertion process that takes just 10 seconds. It’s uncertain whether it has a longer wear-time of 7 days. This one is likely a least a year or two out (~2022-23), as investigational studies are just beginning.
Personalized Closed Loop
Medtronic’s already working on this future version of its closed loop system that would allow for even more customized control via smartphone interface — with auto-settings optimization, optional auto carb coverage, and AI (artificial intelligence) that lets it adapt to patient behavior. All with a TIR goal of 85 percent. Part of this would likely include the Medtronic acquisitions of two startups, Nutrino Health and Klue, for meal-gesture tracking and nutrition data science.
It’s always a question as to when something will even be submitted to FDA, let alone actually approved, but considering the FDA’s breakthrough designation granted for this investigational device in 2019, it may not be too far off.
Dosing claim (plus Medicare coverage)
Medtronic has been slow to seek a “non-adjunctive” status for their CGM sensors that would eliminate the requirement for fingerstick confirmations and allow for Medicare coverage. While every other CGM competitor has snagged this FDA designation, Medtronic has dragged its feet on pursuing it.
Yet, the company tells DiabetesMine it’s had it in mind for a number of years and plans to pursue it for their Guardian 3 sensor and 780G system before long. If okayed by regulators, it would allow the company’s stand-alone Guardian 3 CGM system as well as the sensor-augmented devices to be eligible for Medicare coverage.
Tubeless patch pump?
Once upon a time, Medtronic Diabetes had its sights on a patch pump that wouldn’t include the traditional tubing its devices had. Industry observers recall the company’s plan way back in 2008 — just a few short years after the tubeless Omnipod first hit the market — to develop its own disposable patch pump.
Medtronic Diabetes all but scratched that idea years ago, but every so often it gets a mention and renewed interest. As of mid-2020, the Omnipod remains the only one of its kind, despite many patch pump wannabes who’ve come and gone and are still talking about future products.
As part of all this future tech, Medtronic is ramping up for pivotal trials needed to get the coveted “iCGM” interoperability classification. As of mid-2020, the Dexcom G6 has this designation to work with closed loop technology while the FreeStyle Libre 2 has a limited version of iCGM status, meaning it cannot be currently used with automated insulin delivery devices.
In June 2019, Medtronic and Tidepool announced it would work on a future interoperable closed loop — separate from the above-mentioned 780G/AHCL and Personalized Closed Loop systems. No word on how far off that may be, and what features it may offer.
We finally saw the end of an era as to Medtronic’s original insulin pump models that looked like colorful pagers in 2018. Those are still widely used but are now officially discontinued and no longer available to buy. The supplies are becoming more difficult to find as time moves forward.
In its heyday, the Minimed 530 was monumental because it did what no other insulin pump had done before: It automatically suspended insulin delivery if you crossed a certain low glucose threshold. Medtronic snagged FDA approval for that Low Glucose Suspend (LGS) or threshold-suspend feature in September 2013 and it remained available until October 2018, when Medtronic discontinued it and earlier “5-series” pumps in favor of the newer 6-series devices.
Ironically, many in the #WeAreNotWaiting DIY (do-it-yourself) diabetes innovation community are still using these older insulin pump models, as they remain quite reliable and — cover your ears, FDA and diabetes educators leery of off-label product use — are able to be hacked.
Despite an FDA warning and mainstream media concern in 2019 about these homemade systems being non-cybersecure because of the outdated technology, they do remain in circulation.
Access and affordability are critical issues that exist as barriers to technology for too many within the Diabetes Community.
Insurance coverage plays a big part of that, but unfortunately Medtronic has been a controversial company on that front in recent years.
In its push toward “value-based” or “outcomes-driven” care, Medtronic signed a deal in 2016 with health insurance giant United Health Care (UHC) that made Medtronic’s pumps the “preferred brand” for its plan holders. A similar deal followed in 2019 for the latest Medtronic tech approved for children.
This restriction of choice rubbed many in the D-Community the wrong way, to put it mildly. While UHC and Medtronic both point out that exceptions can be made in certain cases, the fight rages on against this form of non-medical switching that overrides doctor and patient preferences for business reasons. Fortunately, UHC began offering a choice on July 1, 2020 when it expanded the in-brand covered items to include Tandem Diabetes technology along with Medtronic’s products.
In the end, it comes down to the simple reality that #DiabetesAccessMatters. No form innovation is impactful if people can’t get their hands on it.
While Medtronic certainly deserves credit for what it’s accomplished in bringing new technology to the community, we implore them to also help foster patient and doctor choice.