A Small Step

A Small Step

Before we get too deeply into today’s post we would like to issue a clarification – In our post yesterday we stated – “Although 95% of the patient population does NOT use insulin it’s amazing how much attention these patients receive.” This statement is incorrect as approximately 30% to 35% of Type 2 patients do follow insulin therapy – what we meant to say was that 95% of the patient population is defined as Type 2 and only a small percentage follow intensive insulin management. We regret this error and wanted to correct it as quickly as possible. Next time we will do a better job of proof reading.

Now on to today’s news which is not earth shattering by any means but does point to just how far we need to go even with all the whiz bang way cool technology out there. Today Tandem Diabetes (NASDAQ: TNDM) announced that they have received FDA clearance for their remote software update tool. According to a company issued press release;

“Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim®, t:slim G4™ and t:flex® Insulin Pumps, today announced U.S. Food and Drug Administration (FDA) clearance of the Tandem Device Updater, a Mac® and PC-compatible tool for the remote update of Tandem insulin pump software.

“This clearance, combined with the flexibility provided by our pumps’ touchscreen interfaces, uniquely positions Tandem as the only insulin pump company with the ability to provide its customers access to new and enhanced features, separate from the typical multi-year warranty hardware replacement cycle,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “It’s a way to deliver ongoing innovation to our customers faster than the industry has been able to in the past, which is of particular significance as our artificial pancreas efforts accelerate.”

The first use of the Tandem Device Updater will be for deployment of the latest t:slim® Insulin Pump software to in-warranty t:slim Pumps purchased before April 2015. This updated software began shipping on new t:slim Pumps as of April 2015 and includes a variety of product enhancements for convenience and flexibility. Future software improvements and enhancements will be implemented through the Tandem Device Updater as they are cleared for commercial distribution.”

When Diabetic Investor went to the site to check out this “innovation” www.tandemdiabetes.com/updater we were somewhat taken aback by the fact that the patient must physically hook up their pump via a USB cable to their computer to receive updates. Frankly we have become so used to seeing way cool whiz bang cloud enabled stuff that seeing a device physically attached to a computer caught us off guard.

Yet this shows just how far the insulin pump world still has to go. The reality is if you ask any insulin pump patient and it does not matter which pump they use; they would like nothing better than the ability to control their pump using their smartphone. This would not only help the patient but would vastly change pump design and costs for insulin pump companies. The most obvious beneficiary of such a change would be Insulet (NASDAQ: PODD) who’s OmniPod system which is controlled by a Personal Diabetes Manager.

But Insulet is not the only company who would benefit as Animas, a unit of Johnson and Johnson (NYSE: JNJ) and of course Medtronic (NYSE: MDT) would also benefit. Think of how much smaller a pump could be if it didn’t need a screen, not to mention the cost savings too. Think of how much easier it would be to share information using a smartphone with smart apps.

There is no question that we quickly moving to an area where the patient’s smartphone is becoming the hub of their diabetes management system. Frankly what we have seen to date with all this way cool whiz bang cloud enabled devices is just the beginning and in a few years will seem like child’s play compared to what is coming.

Earlier this month we read an interesting article published by HealthData Management which contained the following;

“Eric Topol, MD, director of the Scripps Translational Science Institute and chief academic officer of Scripps Health in La Jolla, Calif., who says that the digital revolution has been occurring since the middle of the last century. Even so, the healthcare industry continues to only minimally leverage information technology.”

The article goes onto state;

“Nonetheless, with more than 80 percent of U.S. adults owning smartphones, he believes healthcare is on the cusp of a fundamental shift in who controls data. That transfer of control will effectively shift power from physicians to patients, who will play a dramatically more important role in their own care. In the future, consumers armed with mobile phones will gather data from wearable sensors to prevent or better treat health conditions, Topol said, with these devices serving the role of a digital medical assistant or coach.”

We have said many times that diabetes is the posterchild for smartphone interventions as there is general agreement on what is and what is not good control. There is also general agreement on what a patient should do once the data has been gathered and analyzed. The most enticing possibility of all is “personalized” diabetes management where recommendations are actually customized for the individual patient. Recommendations which will be made using more than just glucose data.

The day is coming when sensors will not just measure glucose but additional data points. The day is also coming when each time a patient steps on a scale that data point will be added to equation.  We can even envision a day when the patient performs their own blood tests at home with these data points also added into the mix. This may sound crazy but just take a look at where glucose testing was say 20 years ago and see where we are today.

Going back to what we noted yesterday even with all these advanced technology systems still need to be designed to accommodate for different therapy regimens. The one thing technology no matter how whiz bang or way cool it is can do is make a patient take their pills, or insulin injections. Yes, they can remind a patient to do so but that’s all they can do. It is the patient who must take the action step.

The reason we believe this technology can succeed is because of the people who are going to be using it. The simple fact is the time this technology is fully ready for prime time today’s millennials will be the ones using it. This is a generation that lives attached to their smartphones. Quite frankly this generation will expect their smartphone to be the hub of their diabetes management system.

Now for old guys like us here at Diabetic Investor all we can do is watch as this technology develops. Yes, we will reap some of the benefits of all this whiz bang way cool cloud enabled technology but truth to be told the real benefits are still years away. This is not so much to do with the technology itself rather something called the FDA. The FDA isn’t opposed to the smartphone being the hub of a diabetes management system, they just need time to wrap their arms around this and become comfortable with it.

We should get a glimpse into how the FDA feels next week when Dexcom (NASDAQ: DXCM) goes before an FDA panel seeking a replacement indication. Put into laymen terms this means patients could dose based on the data provided by their Dexcom CGM rather than confirm readings with a conventional glucose monitor. Truth be told many Dexcom patients have been doing this already. Still it would be a pretty big step if the FDA approved such a change and most experts seem to think the FDA will do so.

Change as we all know is not something that necessarily occurs overnight, especially when medical devices and the FDA are involved. It should also surprise no one that technology is moving faster than the regulatory bodies who must approve its use. This is one reason we believe many of the high tech newcomers from Silicon Valley will not build certain sensors directly into new smartphones. That it’s better that these new phones communicate with these sensors.

As we have noted many times new smartphones come out every six months or so while it takes the FDA six months just to schedule a meeting.

There is no question we are headed in the right direction and diabetes management will change but the harsh reality is we are not there yet. Companies must acknowledge this fact and balance the needs of today versus the promise of tomorrow.