Moving ever closer

Moving ever closer

This morning two items caught the attention of Diabetic Investor, the first was a story on how Dexcom (NASDAQ:DXCM) will be integrating with the soon to be launched Apple Watch and the second about a company named Miraculins Inc. which is developing a non-invasive  diabetes screening test that takes just 90 seconds to complete.

Let’s tackle the Dexcom news first which really isn’t news as Dexcom has been very clear from the beginning that they intended to integrate their system with not just the Apple Watch but also a patient’s smartphone. Yet what makes the Dexcom news relevant is how the company worked with the FDA instead of complaining about how the agency works. While Diabetic Investor certainly understands the frustration of diabetes devices companies who work with the agency, we also felt that far too many of these companies did nothing more than complain about the FDA rather than work with the agency.

The simple fact is the FDA is moving closer to understanding that mobile technology will become a valuable tool for patients with diabetes. While the agency may not be moving quickly they are moving in the right direction. As stated in a story in today’s Wall Street Journal;

“Previously, the FDA considered glucose monitors and any associated software to be Class III medical devices, meaning they received the highest level of regulatory scrutiny. But the spread of NightScout, the system developed by the group of software engineers, and DexCom’s submission of a separate iPhone app for review prompted the FDA to change course last month.

DexCom’s monitors will remain Class III devices, but software that helps display the data they produce on mobile devices or smartwatches now only needs to be registered with the FDA and doesn’t require prior marketing approval.”

As we have noted many times IF interconnected diabetes management (IDM) is ever to become the standard of care several dominos must fall. One of those dominos was the FDA and how they regulated the apps that work with diabetes devices. This move by the agency that apps don’t require prior marketing approval and only need to be registered with the agency is a significant and very positive step in the right direction.

Kudos to Dexcom for being proactive with the FDA.

The news regarding Miraculins could also be significant as it’s well known that there is a huge undiagnosed population. Any test that makes it easier to diagnose diabetes could help patients avoid many of the costly complications from poorly controlled diabetes. The harsh reality is these undiagnosed patients can’t treat or manage a disease they don’t know they have. As numerous studies have shown the sooner patients start treating their diabetes the better.

What also makes the Miraculins news important is that this system might actually work. As regular readers of Diabetic Investor know we have a healthy amount of skepticism when it comes to anything that’s billed as non-invasive. The quest to develop a truly non-invasive glucose monitor is littered with failure. This quest extends to a non-invasive diabetes screening. Millions of dollars and untold hours of research have been wasted on this quest which so far has yielded nothing, nada, zilch.

Now it remains to be seen if Miraculins has found the secret formula for success but for the first time the experts we’ve spoken with on their approach aren’t laughing and actually paying attention. Given that Miraculins management plans to file pre-submission documentation with the FDA regarding the de novo classification of the Scout DS(R) device in the first quarter of 2015 we will soon find out.

Taken together both stories show how the diabetes device world is transforming. IDM will only fulfill its potential IF the FDA continues to reform itself and given recent events it appears as though the agency albeit slowly is moving in the right direction. It would also be helpful to have true non-invasive screening device given the huge undiagnosed patient population. Many believe that Diabetic Investor is somehow against anything non-invasive and nothing could be further from the truth. What we’ve been against are non-invasive devices that don’t work and companies bilking investors out of millions of dollars for a technology they know doesn’t stand a chance of ever getting FDA approval.

Still even with this progress the biggest domino that must fall is turning all this data no matter how it’s gathered or where it is displayed into actionable information. This is truly the Holy Grail for diabetes.  Should all this time, effort and money only yield easier access to data then we’ll be no better off in the future. The real promise lies not in the data but transforming data into actionable information which ultimately should yield better patient outcomes. We’re getting closer but we still have a long way to go.