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When it comes to diabetes devices and apps, FDA prefers mixing and matching

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Mix and match is no longer a term reserved for the apparel world.

It found its way into a slide deck featuring the Food and Drug Administration’s perspective on digital apps and medical devices at the annual meeting of the American Diabetes Association that kicked off in San Francisco on Friday.

Courtney Lias, director of the Division of Chemistry and Toxicology Devices Office, part of FDA’s Center for Devices and Radiological Health strongly spoke in support of developing interoperable devices that could wirelessly communicate not only with each other but with other digital apps.

For instance, a continuous glucose monitor from Dexcom can communicate with a Tandem Diabetes insulin pump and an automated insulin dosing systems for instance. Or a smartphone can communicate with the CGM to deliver readings instead of a Dexcom-developed reader that can display the glucose values being gathered by the CGM.

“We want to incentivize interoperability and open systems through optimized regulatory pathways,” Lias said, noting that the agency has taken two regulatory actions to create a “pathway for devices to become integrated with each other including apps.”

The first was back in March 2018 when Dexcom’s G6 CGM won a de novo clearance as the “first fully interoperable CGM system” for children aged two and above as well as adults. With this clearance, FDA was signaling to industry that there are streamline reviews if manufactures bring such iCGM (integrated continuous glucose monitoring) systems to the marketplace.

And then, earlier this year in February, Tandem Diabetes Care became the first insulin pump maker to win the ACE pump designation from the agency where ACE stands for alternate controller enabled insulin pump. That device is intended for children aged six and older and adults. In the de novo clearance letter sent to San Diego-based Tandem Diabetes Care, FDA noted:

“ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.”

Typically, CGM devices and insulin pumps are worn by patients living with Type 1 diabetes.

At the time, the chief mission officer of the nonprofit JDRF, (Juvenile Diabetes Research Foundation) hailed the regulatory clearance.

“Diabetes isn’t a one size fits all disease. We are thrilled to see FDA and manufacturers moving to allow communications between different diabetes devices. This will provide people with diabetes more options, accelerate innovation, and most importantly improve diabetes outcomes,” Aaron Kowalski said, in a statement on JDRF’s website.

For FDA, encouraging interoperability by creating two new categories of CGMs and insulin pumps isn’t simply about providing patient choice. Neither is it a sign that it is acknowledging dual market realities — consumerization of healthcare and advances in digital technology. It is also very much a matter of safety.

“When a manufacturer makes a device and it is intended to work with only another specific device, when they maintain the safety of the device through software changes or through design changes in the product, they only have to consider the risks for the uses that they designed for,” she said. “So if somebody is using that device in a certain way that isn’t part of the manufacturer’s what we call the intended use of the product, then the risks of doing that is not assessed.”

But if manufacturers are developing interoperable devices that are designed to communicate either with other devices or with software or digital apps, then it becomes incumbent on them to test myriad use cases.

“In this case when we have devices that are intended to be integrated with other devices, the manufacturers now have a responsibility for assuring the safety of that communication between the devices,” Lias said.

In fact FDA had to issue a broad safety warning to consumers on do-it-yourself diabetes devices in February when a patient fell ill, something that Lias alluded to in her presentation on Friday. The patient had been using an unapproved DIY automated insulin dosing system application and there was a some sort communication error between three unapproved devices that the patient was using. That “resulted in an overdose of insulin in the patient” she said.  Luckily the patient survived after being treated.

So, if industry can be encouraged to develop interoperable devices, diabetes patients may feel less compelled to hack systems for their own personal use that may have unknown risks.

At the same time, Lias recognized the need for patients to be able to use open systems.

“Some of the benefits of interoperability are that they will spur device innovation,” she said. “The pathways we are making allow for both open and closed systems.”

Patients can choose the CGM they like, the pump they like and the algorithm that manages the delivery of insulin they like, she added.

That message of interoperability is being heard loud and clear. Later on Friday, Medtronic announced that it is working with Tidepool — a nonprofit organization that aims to free diabetes data locked in proprietary devices — to develop an automated insulin pump delivery system.

Per the agreement, Medtronic will develop a new Bluetooth-enabled MiniMed pump that would be compatible with Tidepool Loop, an open source automated insulin delivery app for iPhone and Apple Watch that is expected to be regulated by the FDA and which is currently in development. Medtronic will pay Tidepool for integration efforts as well as to develop a software development that can support iPhone communication with the pump. No financial detail was disclosed.

Per the news release, both companies will be working with the Food and Drug Administration  to get approvals for both the Tidepool Loop app and the as-yet undeveloped Bluetooth-enabled MiniMed pump that will work with Tidepool Loop.

“Medtronic makes incredibly robust and reliable pump hardware, and they have extensive marketing, sales, and support organizations for people with diabetes and for healthcare providers,” said Howard Look, founder and CEO of Tidepool, in a Medtronic news release. “This network can help bring closed-loop systems to more people living with diabetes.”

This is an important development in the diabetes world coming from the company holding the largest share in traditional insulin pumps but projected to lose markershare in the future to Insulet and Tandem Diabetes Care.

If this trend continues, FDA may get its after all.

“So what we want to do is incentivize manufacturers to open up systems so that you don’t have only closed systems available to patients so that healthcare providers and patients can discuss the specific apps, the specific CGMs, the specific pumps, the specific glucose meters that works best for that patient and the potential to mix and match these different devices we believe will be better for patients,” Lias said.

Photo: asiseeit, Getty Images

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