Huge diabetes device news, Folks!

In a move that most never expected to see, the behemoth Medtronic Diabetes has agreed to embrace interoperability by developing a future device compatible with the Loop app for automated insulin delivery being developed by Tidepool.

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In other words: Medtronic, the largest insulin pump maker in the United States that has long locked customers in to its own product line, has now willingly and strategically stepped into the #WeAreNotWaiting arena by agreeing to create a Bluetooth-enabled pump that could be used with a Dexcom CGM or other interoperable device, allowing people with diabetes to actually choose system components best for them.

The news was unveiled at our Summer 2019 D-Data ExChange event, held Friday in San Francisco, off-site from the big ADA Conference kicking off that day. Medtronic put out a corporate news release immediately following that.

"This is a very big deal," said a grinning Howard Look, CEO of Tidepool, while making the announcement. "I want to make it very clear that we (at) Tidepool, think that Medtronic is making a very bold and important move here that shows tremendous courage and is the absolutely right thing for the diabetes community."

Also unveiled was that Dexcom will officially join as CGM partner to the Tidepool-supported version of Loop that will be regulated by FDA and eventually offered for download in the Apple Store. This is also big, though not unexpected since the DIY community has been using the Dexcom CGM with closed loop systems, and the company has been working with Tidepool for several years now. 

 

Fostering Interoperability and Patient Choice

Those familiar with the DIY diabetes community know that we've been pushing for interoperability of devices and open data platforms for over a decade now. When Palo Alto based D-data nonprofit Tidepool came on the scene in 2013, they immediately began to shake things up. Most recently, they announced a project to morph the DIY Loop app that automates insulin delivery into a commercial product. They first signed on Insulet as a pump partner, with its tubeless Omnipod pump. Now, they've made the work with Dexcom CGM official, and have actually nabbed Medtronic, the insulin pump market leader and notorious holdout on embracing open source solutions.

"Translation? This means that diabetics will be able to choose their own supported equipment and build their own supported FDA-approved Closed Loop Artificial Pancreases... Open Source Artificial Pancreases will become the new standard of care for diabetes in 2019," writes prominent T1D technology blogger Scott Hanselman. For more, read his post titled, "This Changes Everything."

Next steps are that Medtronic will be developing a new, Bluetooth-enabled MiniMed pump that will be a fully supported delivery device for Tidepool Loop once both are approved. Tidepool and Medtronic will also collaborate on regulatory and software processes, the company reports.

 

FDA Supports a Modular Approach

Also exciting is FDA's public support of an open source, "mix and match" approach to diabetes devices and apps. In two presentations given almost simultaneously on Friday at our #DData19 event and #ADA2019, FDA leaders used a clothing analogy to explain how they strongly support interoperable devices that could wirelessly communicate not only with each other but with other digital apps.

"You don't always want the whole suit with matching tie and shoes -- really you want to be able to pick and choose different shirts, pants and accessories to make the outfit your way," said Alain Silk, FDA's Acting Branch Chief of Diabetes Diagnostic Devices at the DiabetesMine event.

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Alain Silk of FDA talking diabetes device interoperability at our #DData19 event

Dana Lewis, creator of the first open source AP system and a huge #WeAreNotWaiting champion, says, "It's exciting to see more partnerships developing that will provide more choice to patients on the commercial market. I'm also looking forward to potentially hearing about future interoperability around algorithm and AP control interfaces, to accompany a growing selection of device choice options."

Lewis was in attendance at the #DData19 event, where she had generously donated a batch of her new books to attendees on "How to Use an Artificial Pancreas." She may have some updating to do now...

Tidepool emphasizes that the Medtronic deal is one huge step forward, and it plans to court other D-industry players to sign on to its Loop project as well (hello, Tandem Diabetes Care!). Look says that Tidepool's "dancecard is developing nicely, but is far from complete."

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Medtronic's Diabetes Device Pipeline

Some may question Medtronic's motives joining the open source movement now. They've been under fire not only because of complaints about performance of their 670G hybrid closed loop (the first early commercial AP system) but also how they've failed to yet pursue Medicare coverage and the deals they've sealed with UnitedHealthcare locking patients into Medtronic devices as the "preferred brand." While there are official exemptions and ways to appeal, many patients report that they feel forced to settle for devices they and their doctors would not otherwise choose.

In short, Medtronic has some residual ill will to make up for in the D-community.

Here's what we know about what Medtronic has in the works:

  • Minimed Interoperable Pump: No specific timeline has been given yet for the future Bluetooth-connected pump for automated insulin delivery that'll work with Tidepool Loop, but we know it's on the way soon.
  • 780G: Announced on June 8, their next-gen "Advanced Hybrid Closed Loop (ACHL) system" will have the basic form factor of the company's 6-series models with a vertical "modern" look, compared to the older models with a horizontal design that resembled 1980s pagers. The 780G will use a new algorithm the company says is more accurate and reliable. It will provide automatic correction bolusing, will automatically adjust for missed meals, and allow an adjustable target down to 100 mg/dL (compared to the 670G's set 120 mg/dL target). It also aims to achieve 80% user Time in Range compared to the existing 71% TIR shown in data on the 670G. Importantly, this BLE-enabled pump will allow for remote software updating -- as offered by Tandem's t:slim X2 -- so users won't be required to buy a whole new device every time new software features are launched. Clinical trials are now ongoing (see here and here) and should wrap by mid-2020.
  • Personalized Closed Loop: Medtronic's already investigating this future version of its own closed loop system that would allow for even more customized control via smartphone interface -- with auto-settings optimization, optional auto carb coverage, and AI that lets it adapt to patient behavior. All with a Time in Range goal of 85%. The company says it hopes to submit that to the FDA by Fall 2020, something that may be feasible considering the FDA's breakthrough designation granted for this investigational device in 2018.
  • Interoperability Pathway: As part of all this future tech, Medtronic is ramping up for pivotal trials needed to get an "iCGM" classification -- the designation created last year by FDA in approving the Dexcom G6 that refers to CGMs approved to work with related interoperable versions of insulin pumps, and control algorithms/apps. So far, Dexcom is the only CGM approved in this category, though competitors Abbott FreeStyle Libre and Eversense implantable CGM are pursuing this designation as well.
  • Dosing Claim (and Medicare): Medtronic also tells us they're prepping to soon submit an FDA "dosing claim," aka "non-adjunctive designation" -- meaning no fingerstick tests required to double-check CGM accuracy. They hope to submit the claim to FDA for their current Guardian 3 sensor by the end of July. That's a crucial step in getting Medicare coverage, which Dexcom CGM and FreeStyle Libre Flash currently have but Medtronic does not.
  • Future Smart CGM Sensors: We also got a peek at Medtronic's planned future sensors: one called the "Zeus Sensor" that will still have the same seashell design requiring overtape, and their "Synergy Sensor" all-in-one sensor/transmitter that will be fully disposal and have a new look. The Synergy will be a flatter, square form factor 50% smaller than the current model, will not require any overtape to keep it on, and have a simpler three-step insertion process that would take just 10 seconds. Interestingly, Medtronic is planning for both to require a fingerstick calibration on the first day only (a departure from how Dexcom and FreeStyle Libre work without any needed calibrations). As of now, Medtronic forecasts filing the Zeus in mid-2020 and the Synergy in roughly 2021.

As always, access and affordability are critical factors, and that's a whole hot topic in itself.

Meanwhile, it's thrilling to see these open source collaborations happening, all in the name of improving life with diabetes!