You may have heard the big news late last week that FDA has created a new classification for insulin pumps designed specifically to be interoperable with different devices, and granted the first such designation to Tandem’s t:slim X2 pump.

This new category of “iPumps,” officially named Alternate Controller Enabled (ACE) infusion pumps, aims to accelerate regulatory review and pave the way for new connected systems in which patients can pick and choose their pump, CGM (continuous glucose monitor) and even control algorithm.

For many of us, this is a super-exciting development (!) because it gets us one step closer to Automated Insulin Delivery (AID) systems nearing market (aka ‘Closed Loop,’ or ‘Artificial Pancreas’ if you dare use the term) that have already been proven to help patients achieve far better glucose control with less guesswork.

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While this news is exciting, the details can be pretty confusing if you don’t know the lingo, and/or if you’re not exactly clear on how this could change the world for people whose lives depend on insulin.

There are also many questions about these modular, connected systems going forward: How will FDA review a system made up of a bunch of different components from different manufacturers? And what about Customer Support -- will you know who to call if something goes wrong?

No doubt, there’s a lot to unpack here…

 

iCGM, iPump, iController

An AID system is made up of an insulin pump, CGM, and software (algorithm) to control the system. There’s currently only one company in the world that owns all three of those components so can put out a complete package under one brand – Medtronic, of course. Their 670G is a first early version, and their next-gen Minimed 780G closed loop system is expected by April 2020.

Meanwhile, everyone else is partnering up to create these systems:

  • Tandem with Dexcom and TypeZero Technologies (Tandem Control-IQ)
  • Insulet with Dexcom and Tidepool Loop (OmniPod Horizon)
  • Bigfoot with Abbott FreeStyle Libre (Bigfoot Loop & Bigfoot Inject)
  • Beta Bionics with Dexcom and Eversense (iLet bionic pancreas)

FDA has been working diligently on a path to review and approve these combined systems, and made the first step with its new “iCGM” classification in March of last year. Just like with pumps now, that designation allows for CGMs “permitted to be used as part of an integrated system (and) with other compatible medical devices and electronic interfaces.”

As Tidepool explains in their blog post on the announcement, now that we have iCGM and ACE (iPump) designation, the final missing piece is an “iController” category that would create an easy pathway for FDA review and approval of the algorithms needed to make AID work.

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“Two down, one to go. We're working on the iController piece, and we hope other companies are, too,” Tidepool writes.

They also break down why this is so exciting:

“Once approved, any new technology that integrates with one ACE pump should be able to integrate with any ACE pump without an additional FDA filing. That doesn’t account for the work required to make these types of technologies work together, nor for getting the business deals between the companies done, when necessary, but the FDA will not be the barrier to making this happen. And that’s super important (in our humble opinion).”

Don’t forget that people using DIY closed loop systems (i.e. Loopers) are currently restricted to older Medtronic pump models, because those are the only ones they’re able to hack into for connectivity. With these steps by FDA, many more people will essentially be able to ‘Loop’ using the newest products, without having to build the system themselves. 

 

Lots of People Working on This

Tidepool has been a champion of pushing for interoperability, along with our whole DiabetesMine #DData #WeAreNotWaiting community – backed by JDRF with their Open Protocol Initiative, now also supported by Helmsley Trust. 

Last week, JDRF issued a statement noting that the ACE classification “is a substantial step forward for the ‘open protocol’ approach, which allows people with T1D to connect their preferred devices – even if made by different manufacturers – to create and customize a diabetes therapy system that best works for them.” 

Woot!

Tandem’s Big Wins

We have to hand it to Tandem Diabetes Care, which has made an impressive comeback from the brink of death when the company nearly went under last year.

Now they have not only snagged the first ACE interoperable pump approval, but are queued up to be next to market (after Medtronic) with an AID system. Their new Control-IQ algorithm will use readings from the Dexcom G6 CGM to automatically adjust basal insulin to prevent high and low blood sugars. This system will also be able to deliver automatic correction boluses to bring down very high BGs as well, giving it an edge over other systems. As reported by diaTribe, the Control-IQ algorithm is embedded in the Tandem pump, meaning a user will only need to wear the pump and CGM to be in closed loop.

Tandem already has its Basal-IQ product on the market, which connects the t:slim X2 pump with the Dexcom G6 to provide glucose prediction and auto insulin shut-off when a low is predicted. When we interviewed a bunch of users of that first-gen system here at the 'Mine in Fall 2018, they were finding it mostly “crazy wonderful.”

There’s a lot of excitement for Control-IQ to hit market, hopefully by mid-year.

Kudos to Tandem!

 

New Insulin Pump Labeling with Accuracy Data

We learned from Courtney Lias, director of the device division in the FDA’s Center for Devices and Radiological Health, that with this new ACE designation comes a push for “more transparency about how pumps have performed in trials" – requiring that info to be included in product labeling.

“Right now there’s very little info available about pump testing… People who want to use an ACE pump will be able to look in the label and learn about the accuracy of bolus delivery for low, medium and high doses. They can see how much time in range (TIR) was achieved. They could, for example, or say, ‘the minimum bolus amount here is not good for me,’” Lias explains.  

She tells us that manufacturer cross-pump testing includes 30 pumps at a time being evaluated for average accuracy. This pump review data has not been made public to date, but now will not only be included in labeling, but will also be published online by FDA soon – another win for PWDs looking to make an informed choice!

 

FDA on Closed Loop Regulation, Coverage, Customer Support

We asked FDA’s Lias a number of key questions additional about this announcement and how it will handle AID (aka closed loop) systems going forward:

DM) The press release says that in awarding Tandem the ACE designation, the agency "evaluated the ability of the pump to communicate with other devices." How was that achieved?

CL) In a representative manner – we check their ability to use a process to connect to another product.

Essentially, they send us a procedure they’re going to use for connectivity -- a set of software rules and specifications they need to meet. That’s what we cleared. We basically said, ‘Yes, you can use that procedure, you’re now authorized.’

It’s the same with the iCGM designation but this is more complicated because the product can actually dose medicine.

 

So have you established a new connectivity standard?

There is no standard for pump control, but standard types of tech that companies are using for connectivity now. They previously used proprietary radio frequencies, but now are all using Bluetooth LE to connect. Those tech changes helped us, because everyone is using same wavelength now.

 

And this has cybersecurity built in?

A lot require an authentication handshake, to safeguard against controlling another pump that may be nearby. The technology validates the specific pump and each command.

To be clear, this is not a standard process across companies now. The regulation doesn’t get into this. We just say, ‘Yes that connectivity process will work.’ We don’t regulate how it’s done.

 

What’s up with the “special controls” requirements written into your guidance for this ACE designation?

The special controls language is hard to understand. First, they lay out the kind of testing manufacturers will do have to do, which is actually pretty standard but now includes a few more pump-to-pump comparisons.

There’s the communications part, which is the fail-safe piece: if the user loses connection with the controller, the pump has to be able to default to a base setting.

There’s a data logging requirement, which also has to do with sharing data between partner companies.

And there are the new labeling requirements, to provide transparency on testing data. 

 

Going forward, will all pumps need this new ACE designation?

They can choose. For example, if Medtronic comes in with their next-generation of the 670G – the whole system – they wouldn’t need the ACE designation.

But this would also make it easier for Medtronic to upgrade their own systems faster, because with the iCGM or ACE designation, system tech upgrades would not require a new regulatory review.

 

Remind us how this new iCGM/ iPump/ iController path will help accelerate innovation?

For example, Tandem is now in clinical studies with its AID system. When ready, they could send in the stand-alone controller system for review. Once approved, they could it use it on different pump models.

Before, the company would have to wait until the controller was ready with the whole device system together to submit for review, and if they later updated any component, they would have to do a whole new FDA submission.  

When we get to approving those control algorithms, we could potentially authorize multiple algorithms on a pump – and even non-algorithm controllers, like theoretically separate 3rd party apps for pump control.

 

Smartphone apps have actually been capable of dosing commands for a while now. Was it FDA that was holding back on bringing this capability to market?

No, companies were worried about doing that, but now are feeling like they’re ready to get there reliably. Some companies have figured it out and will do it sooner rather than later.

Some have the algorithms on the pump (for example the Minimed 670G) because they want to make sure it still works if you lose connection with the system or app. Others are designing it so the controlling software is in the phone app.

 

How do you envision customer support to work for systems made up of products from different manufacturers? In other words, who would we call for help?

Usually the customer kind of knows which component they think it is having the issue, so they know who to call. But if you went to Dexcom, for example, and they identify it’s not their issue, the are required to assure the customer gets connected to the partner company for service.

We were worried some companies might irresponsibly drop that, so we made it part of the review process that they have to commit that they will contact the other company and provide information about the complaint, along with relevant data from their device.

 

It’s not your direct domain, but what about insurance coverage / reimbursement of these multi-device systems?

We’re talking with leadership at the Helmsley Trust about coverage options – the algorithm is the concern here. How will it be covered?

Medtronic skirted around that of course because it was built into their hardware.  

Roy Beck and David Panzirer are looking at ways to position “value-added by algorithm” to support payment modules.

 

You’ve personally been a champion of faster innovation cycles and interoperability, so this must be an exciting milestone for you…

Yes, as other companies look at making algorithms available, they’ll now have much more available from an FDA perspective.

Right now it’s just the Tandem pump with ACE, Dexcom G6 with the iCGM claim, and Tandem’s Basal-IQ also has the iCGM claim. We’re definitely going to encourage that companies get this new component approval!

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