Wow, what a huge moment for the Diabetes Community!
On Wednesday, the FDA approved Medtronic's Minimed 670G, the first-ever "hybrid closed loop system" that can automatically monitor glucose and adjust basal insulin doses in people 14 years of age and older with type 1 diabetes.
This comes with a firestorm of excitement because it is of course the closest thing to an FDA-approved "Artificial Pancreas (AP) System" ever to hit the market, yet there are also community grumblings about how the AP label is being used to describe this new technology.
While we in the Diabetes Community realize that it's not a fully closed-loop AP that takes over diabetes control completely, and Medtronic itself is being careful to refer to it as a "hybrid," the new Minimed 670G represents a HUGE step forward in automating our disease management. Woot!
Remarkably, this regulatory approval comes only 104 days (!) after Medtronic submitted thousands of pages of documents, which is seven months earlier than expected and this approval caps more than a decade of research, policy, and product development in getting to this milestone.
“This is phenomenal, and I’m so psyched!” says Aaron Kowalski, Chief Mission Officer of the JDRF and longtime type 1 himself. “It’s amazing to be at this level. Think about it -- this is the first time one of these (automated systems) has been approved… and the short time it took the FDA to clear this. "
So, just what is this new glucose control system, and how does it work?
What's a Hybrid Closed Loop?
The term "hybrid" in this case means the system is partially automated but still requires some control by the user.
The way it functions is that the CGM sensor reads glucose data every five minutes, and the closed loop algorithm built into the pump uses that information to increase or decrease basal insulin to keep glucose levels as close as possible to the target of 120 mg/dL. Users still need to enter carb counts and bolus amounts for 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 result is entered just as all standard insulin pumps do now through the Bolus Wizard feature.
This FDA page does a nice job explaining the details. The MiniMed 670G System has two modes, one more "autopilot" than the other, but both require user intervention (thus, not a completely closed loop):
Manual Mode - in which the system can be programmed by the user to deliver basal insulin at a pre-programed constant rate. The system will automatically suspend delivery of insulin if the sensor glucose value falls below or is predicted to fall below a predetermined threshold. The system will also automatically resume delivery of insulin once sensor glucose values rise above or are predicted to rise above a predetermined threshold.
Auto Mode - the system can automatically adjust basal insulin by continuously increasing, decreasing, or suspending delivery of insulin based on CGM values (different from Manual Mode where basal insulin is delivered at a constant rate). Although Auto Mode can automatically adjust basal insulin delivery without input from the user, the user must still manually deliver insulin during meals.
This is a new type of device never before seen on the market -- and the fact that it's approved here in the U.S. first, before hitting the European and international markets, can hardly be overstated.
Minimed 670G Product Specifics
Outwardly, the Minimed 670G looks and feels almost identical to the company's recently-approved Minimed 630G that brings a new vertical orientation and color screen display to Medtronic's standard pump design.
The big difference is that this insulin pump-CGM combo is controlled by a sophisticated algorithm Medtronic dubs its "SmartGuard Hybrid Closed Loop technology," which can make those automatic adjustments to basal insulin and auto shut-off when needed. The product specifics are as follows:
- Pump Unit: As noted, the look is the same as the Minimed 630G introduced just last month (already obsolete?). Same AA battery, same infusion sets and 300-unit insulin reservoir, and a little bit larger than the traditionally-styled Minimed pumps with their horizontal orientation. In contrast to older Medtronic pumps, this device is only being offered in black, but you can buy a number of different skins to jazz up the look if desired.
- Buttons and Menus: The only slight differences between the 630G and the new MiniMed 670G are the fact that the top right button takes you directly to CGM graphs, versus the path to Menus, and the Menu itself differs a bit, given the new mode choices, etc., on the new system.
- Color Screen: Like the 630G, the new system also sports a bright full-color screen (!) that adjusts automatically to lighting situations, so for example at night it won't light up as brightly as it might during the day. This appears to be much easier to read, a great benefit for anyone with visual impairments of course. Alongside basic pump and CGM data, Insulin on Board (IOB) is displayed right on the homescreen -- something users have been clamoring for.
- CGM Tech: The new system uses Medtronic's fourth-generation seashell-shaped CGM sensor, which had been referred to as Enlite 3 but will now be known as the Guardian 3 sensor (we have a rundown of all the different Medtronic terms over on Storify). It is cleared by the FDA to wear on the body for 7 days, compared to 6 days for previous generations. Nothing's new on the adhesive front, though.
- Enhanced Accuracy: The Guardian 3 is more reliable and accurate, Medtronic says, because it uses a new radio signal (introduced with the 630G) to communicate between the transmitter and sensor. According to the company's clinical pivotal trial data at two calibrations per day, the MARD error rate is on average 10.55%, which isn't as good as the latest Dexcom G5 at 9% but is much better than the ~14% the current Enlite has to offer -- so that's a potential game-changer in making Medtronic a stronger competitor in the CGM market!
- Your Mode May Vary: Medtronic says it listened to people about wanting choice, so it's allowing that switch between modes: Auto Mode for the hybrid closed loop function, or Manual Mode that still offers the Suspend on Low feature for when you cross that hypo threshold (like the 530G and 630G both have), and the Suspend Before Low that can be set to predict hypos 30 minutes before they happen (as in the internationally-available 640G).
- Set BG Target: This technology is designed to "treat-to-target," meaning it works to keep BG levels close as possible to 120 mg/dL. Unfortunately, that cannot be changed... meaning Medtronic only takes the "personalization and customization" so far. User can set a temporary target of 150 mg/dL for up to 12 hours to deal with situations like exercise, but that's the only flexibility built in. Medtronic says this was a result of trying to get to market first, because allowing different targets would mean much larger clinical trials that would have delayed regulatory approval and commercialization. Future generations will likely allow for varying target levels, Medtronic says.
- No Data-Sharing: Like the earlier Minimed 630G system, this 670G Hybrid Closed Loop does not have built-in Bluetooth and will not work with Minimed Connect for mobile phone data-sharing (?!). For those who want data-sharing, Medtronic is pointing people to their Minimed 530G system that's now more than three years old. As a result of this lack of connectivity, the 670G won't work with any of the IBM Watson or data-sharing mobile apps under development.
- Connected BG Meter: The system is set up to communicate directly with the Bayer Contour Link 2.4 Meter that Ascensia introduced with the 630G launch announcement. This allows for remote bolusing from the meter, but only when in Manual Mode rather than in the closed loop Auto Mode.
- Two Calibrations Daily: The system requires at least one fingerstick calibration every 12 hours, and if not entered, it automatically kicks the user out of Auto Mode.
- One-Press Serter: The 670G uses Medtronic's new One-Press Serter that it says will make sensor insertion easier and more comfortable. It requires just a single button press, compared to the previous generation serter that was bulkier and required two button presses (once to insert and once to retract).
- Kids and Teens: Minimed 670G is officially labeled for ages 14 and older, but the company says it's already conducting trials for approval in kids between 7-13, as well as feasibility studies for those as young as 2. The current FDA approval letter states specifically that the 670G should not be used in those younger than 7 years old, nor in those who take less than 8 units of insulin per day (as the device requires that minimum per day to operate safely).Metronic says it doesn't have enough data in those who take less than 8 units per day to know if the algorithm is effective and safe.
Availability and Cost
With the much-quicker-than-expected regulatory approval, Medtronic tells us they need at least six months to prep for the U.S. product launch starting in Spring 2017. For those outside the States, Medtronic says to expect regulatory approval sometime in mid-2017.
There are a lot of "moving parts" that need to be in place pre-launch here in America, they explain, plus they're currently sitll in the midst of the Minimed 630G launch; that previous model just recently began shipping to patients in the U.S.
Yes, there will be an upgrade pathway to anyone using current Medtronic products -- called the Priority Access Program. It's actually encouraging customers to start on the Minimed 630G in the coming months before the 670G hits the market, advertising that a transition like that will help patients train for the new platform and potentially reduce their out-of-pocket costs to low as $0.
- Priority Access program initial cost = $799
- Trade-in credit on MiniMed 630G pump & CGM system = $500
- Total out of pocket program cost = only $299
- Participating in surveys and other user feedback programs can also reduce that cost, to as low as $0 for some people, the company states
The Priority Access Program runs through April 28, 2017. Medtronic also says more offers and upgrade possibilities may be revealed closer to launch time in the Spring.
Of course, Medtronic will also be working in the coming months with payers and insurance companies on coverage for this technology. With all the recent controversy over these issues (#DiabetesAccessMatters), we hope Medtronic keeps in mind that while many patients will want this system, it may not be the best choice for all -- and choice matters!
'A Watershed Moment... Transforming Diabetes Care'
The JDRF issued a news release on Wednesday, expressing excitement about this landmark technology and how quickly the FDA moved. The American Diabetes Association also chimed in with a news release on this approval, noting its significance.
Think about it: Ten years ago, many still thought a closed loop system of any kind was a pipedream. But JDRF laid out a real blueprint on moving toward an Artificial Pancreas. That was still the very early days of CGM technology... and look how far we've come!
"This moved incredibly fast, and it shows how important all the hard work was that we did on the policy side back in the day, to create guidance for these systems," said Kowalski, who personally played an important role in making AP tech development a priority. "That changed everything and created a pathway, and now we're here. It's massive, truly a watershed moment that has the potential to transform diabetes care!"
Whether you consider the Minimed 670G an "Artificial Pancreas" or not is almost beside the point... The fact is we have a device now that's closing the loop in ways we haven't seen before, constituting an early AP generation. It's potentially life-changing technology that's been made available in record time.
In fact, the FDA gave market approval for this Minimed 670G while also requiring additional post-market studies aimed at better understanding how the device works in real-world settings. That shows the FDA is willing to look at existing data and trust the benefits, without holding back for reams of future data.
The journey is pretty amazing indeed, as captured in this post by D-Mom and longtime JDRF advocate Moira McCarthy Stanford on how the organization paved the way to this milestone and beyond.
We also spoke with Jeffrey Brewer, who heads up Bigfoot Biomedical that is developing its own closed loop system expected to be available sometime in 2018. Along with Aaron Kowalski, Brewer is considered to be one of the "Fathers of the AP" given their role in helping to develop and promote the closed loop pathway at the JDRF.
"We're excited that the FDA is moving faster and is more supportive of automated insulin delivery systems and we look to be aided by the same winds!" Brewer told us.
No doubt, this will move the needle forward on the more than 18 other closed loop systems in the works -- especially those that use insulin only. Some add the additional hormone glucagon to the mix to combat hypoglycemia (like Beta Bionics iLET and Pancreum Genesis), which may require more FDA evaluation time.
We're happy to hear our friends within the do-it-yourself community at #OpenAPS are also excited about this newest approval, and what it means for all of us.
It's great to see the FDA moving so quickly, not only on this Minimed 670G approval but with other exciting diabetes tech and data developments in recent years. Clearly, the FDA is recognizing the #WeAreNotWaiting movement, and doing its best to keep up with these fast-moving times.
FDA Approves Libre Pro
It's worth noting that the FDA also gave the green light on Wednesday to the Abbott Freestyle Libre Pro system here in the U.S.
This is not a consumer device, but the clinician version of Abbott's new Flash Glucose Monitoring (FGM) technology that's already available to patients abroad.
Also referred to as a "hybrid" system -- but only for glucose monitoring -- Abbott Libre consists of a small round sensor worn for up to 14 days on the back of the upper arm, and a controller that users just swipe over it as many times per day as needed or desired to take wireless glucose readings.
It doesn't offer any alarms for rising or dropping glucose levels, and the consumer version abroad stores just 8 hours of data. The aim is to create a simpler monitoring solution that could also help many type 2's be more in touch with their glucose levels in real-time.
While not a traditional CGM as we know it, Abbott says the regulatory rules classify Libre as a CGM. And what they've approved now is a version designed specifically for doctors to lend to their patients for short-term use, and it only provides blinded data for the doctors to view. It's a first step towards the consumer version, which Abbott has also recently filed for FDA approval here in the States.
Hopefully, that will be coming soon, with FDA's seemingly escalated innovation fast track.
A huge thanks to all those involved -- not least those at FDA -- for moving these important diabetes care tools forward in all of our best interests!