Some Perspective

Some Perspective

Now that we’re back from EASD, and yes, we will have more on that conference in an upcoming post, it’s time to address an issue that is taking on even greater importance with the proliferation of interconnected diabetes devices. The goal of interconnected diabetes devices and all the way cool whiz bang toys that come with apps is to help patients better manage their diabetes.

As we have noted many times in the past these interconnected tools are largely targeting insulin using patients. Whether they are all the new so-called “smart” or sensor augmented insulin pumps or whiz bang way cool conventional monitors which talk to the cloud or the upcoming series of “smart” insulin pens, helping insulin using patients is the low hanging fruit for interconnected diabetes management (IDM).

Although no one likes to talk about it much there can be serious consequences when these systems fail or malfunction. Again, as we have stated insulin is not just a life sustaining drug it is also a lethal drug when delivered incorrectly.

The reality is sensor augmented insulin pumps are basically a collection of devices designed to work together, the most whiz band of these being the new 670G from Medtronic (NYSE: MDT). The best way to think of these systems is to think of a bike chain, when all the links in the chain function the bike rides flawlessly, however should any link break the entire system goes down and the bike doesn’t ride.

Systems like the 670G are akin to very sophisticated computers. Using complex algorithms, they process information gathered by another very important link in the chain, glucose sensors which measure glucose levels on a continuous basis. In the case of the 670G once in auto mode the patient is taken out of the loop and it is the system that determines how much insulin to deliver. Other sensor augmented insulin pumps have not yet reached this level but it’s only a matter time before they do.

This is one reason Dexcom (NASDAQ: DXCM) continues to harp on how accurate their sensors are and they are the only sensor company to be approved for a replacement for conventional finger sticks when it comes to dosing decisions. It’s also no secret that most experts believe the Dexcom is the most accurate sensor and that the new Medtronic which is the straw that stirs the 670G is inferior to the Dexcom system. Which when you think about it is somewhat ironic as if this sensor does deliver inaccurate information to the pump it can deliver a lethal dose of insulin based on this inaccurate information.

Many of these same experts believe this accuracy issue is the reason the FDA has yet to approve the FreeStyle Libre from Abbott (NYSE: ABT). The FDA is many things but stupid is not among them and they know that insulin using patients will be using the Libre and that these patients will use information from it to make insulin dosing decisions even if it is not approved for this. This is exactly what Dexcom patients did before they gained approval as a replacement for finger sticks.

Yet what gets lost in this battle over accuracy and reliability is one fact, that these are machines and machines do fail or malfunction. Try as they might to manufacture systems that do not fail or malfunction these things can and do happen. There is no such thing as any diabetes device that works 100% of time without ever failing or going haywire. To put this in terms everyone can grasp think of your smartphone a device which works most of the time but they can and do malfunction. Now imagine if that smartphone basically held your life in its circuits.

Our concern here is where it always is, with the patients using the devices and systems. Let’s be honest the companies who make these devices companies like Dexcom and Medtronic spend tons of money to minimize risk. Medtronic just by way of example built in several fail safes to the 670G. This is not just prudent but also a sound business decision as the last thing any of these companies want is litigation.

To be honest we aren’t as sure about all the newcomers to this wacky world who are now dispensing advice. Yes, apps are sure cool but how many have undergone the rigors the FDA approval process. In the real-world patients are using these apps to make insulin dosing decisions.

We are particularly concerned with insulin pump patients as sensor augmented systems become more popular. While these tend to be more sophisticated patients the fact is a growing number seem clueless to the risk. Yes, many of us basically accept the fact that we are using devices that can and do malfunction it is a risk we are willing to take. However now with the approval of the 670G a growing number seem to believe you slap it turn it on and the system does the rest. We do not blame Medtronic for this perception but it does exist.

Here is where things get a little complicated as the question is how does a company insure that a patient understands this risk without hurting sales. Equally complicated is the pace of innovation. While making an app go through the rigors of the FDA approval process seems like a good idea, this is a long and costly process.

Which brings us to the biggest question of all; can balance be brought to the system? Can patients be informed of the risk without making that risk seem overly draconian. As we have noted when these systems work as designed they do make the patients life easier and outcomes better. It’s when they fail or malfunction when the problems arrive.

Everyone keeps clamoring for newer and better systems. Many bitch that the FDA process is too slow and some have taken matters into their own hands. Yet this risk is very real and the patient should be informed of the risk they are taking. Listen most of us who fly understand yes there are risks but airplane crashes are rare events. The same is true with the drugs patients use although few read labels they are informed of the risk. Yet when it comes to devices particularly interconnected devices something needs to be done.