Hacked- safe? or sorry?

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We all want to know what is going on with our bodies.  And, if we are dealing with our kids and other loved ones- we are often desperate to insure their health and safety.   So, it’s not surprising that parents have decided to take some matters into their own hands.

Take one of the more common glucose monitors on the market (Dexcom).  Their device, CGM (continuous glucose monitor)  is designed to provide dynamic (almost real time) measurements for a child’s glucose levels.

(This is used when the child has Type I diabetes.  Type I used to be called Juvenile Diabetes, which typically diagnosed before the age of 30.  This form of diabetes is where the pancreas fails to produce sufficient insulin, which is critical to the body’s glucose metabolism.)

continuous glucose monitor
Dexcom CSM glucose monitor www.dexcom.com

The CGM is comprised of three components- a subcutaneous (under the skin) sensor that determines the glucose level about every 5 minutes; a wireless transmitter that sends the sensor’s data to the third component; the receiver and display apparatus.  This receiver depicts the child’s trends in glucose levels- and actual data- in the high, low, and normal ranges for quick analysis. The problem is that an adult (or a knowledgeable child) must be contiguous to this receiver.  Because the signal is not transmitted over the web.

So, many parents of these children never let their kids far out of their sight.  To insure that their glucose level is under control and that no coma can result. Until and unless these parents found “NightScout.  (Nightscout DOT info seems to be down.  Check it first.)

This “product” is a series of hacks (oh, wait- they call it “open source”) that afford parents- and other interested parties- the ability to access the Dexcom results via their smartphones, their computers, their tablets, or a special watch (‘Pebble’).  In essence, this hack lets the receiver attach to the web, so the data can be read anywhere and anytime.

Obviously, this is not making the Food and Drug Administration (FDA) very happy.  After all, no one has verified that this hack is safe, works routinely, or even can’t be manipulated by nefarious individuals.  (Could you imagine if someone hacked into the device and always presented normal levels- so no insulin would ever be provided when needed, or high levels- so an overdose of insulin would be administered?)

Or, what if you were Dexcom,  the device manufacturer?  What liability would you now have, since the device you designed and insure is safe and effective, yet has been modified by folks in the field?  Folks who may actually know nothing about electronics and/or medical device safety?

Now, before you jump the gun and think I am overreacting (since this is just a monitor and not an insulin pump), you should know that the hack relies on 3rd party connections to the web.  And, those connections have failed more than once – meaning there was no data available.  So, if you were relying on remotely knowing what your child’s glucose level was at that moment, you were simply out of luck.  And, that hack has absolutely no data security. (Think [Sorry- Business Week JUST decided that these articles require you to have a very expensive subscription to their business systems, but they were published 2 Sept 2014- Home Depot- and 13 Mar 14- Target] or JP Morgan Chase.)

It gets better (or worse, dependent upon your point of view).  At least one engineer has begun determining what insulin doses may be needed, based upon the Dexcom data and suggests those levels to be administered to the patient.  Which makes this hack into a Class III Medical device.

(FDA has created three different classes, which set different degrees of safety and effectiveness that must be proved (or not). Class I Medical Device are basically simple systems that are subject to little regulation. Class II Devices are more complicated devices that have special instructions and controls, and undergo simple testing to insure they are equivalent to similar devices on the market already.  The highest controls exist for Class III Devices, which are complex systems that need testing and approval before they are marketed.)

It’s a brave, new world out there.  And, folks may be putting themselves- or their kids- at tremendous risk.

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8 thoughts on “Hacked- safe? or sorry?”

  1. This is a frightening prospect, no doubt. I watch my adult boyfriend, who has been Type 1 since the age of 8, closely monitor and control his insulin to glucose ratio very carefully each day. He wears a pump, but still must closely monitor and adjust his levels to what he eats. I have noticed that there are days it is a battle to keep the two in balance, especially if we are working on a project or our meals are spread further apart than usual. Monitoring a child must be an even bigger challenge. I agree with you; this is a sloppy way of helping to monitor a child. I don;t think I could trust a hack, nor would I depend on it for key information. I still feel that hands-on, with-a-meter, monitoring is the only way to go. Technology just needs to catch up before we relax that much.

    1. Karin:
      I think you expressed, from a personal view, the anguish and tension that exists in insuring the proper control of one’s glucose levels. And, why many are seeking any means to make this control less stressful and more automatic. But, unless and until the proper controls are provided, it’s the personal care that protects the life of the Type 1 individual.
      We can’t let go of our steering wheels in the car yet, either… But, we can watch developments that may let such improvements (hopefully, they are) develop!

      Thanks for the visit AND the comment.

  2. This is great information for those out there that feel they need to have the latest thing on the Market. If this does get established, it won’t be long before they add the delivery system right to an arm band or something. This would Not be for me anyway………
    Chef William Chaney recently posted..Winter Squash are Here

    1. You are correct, Chef William- these developments are in the pipeline, because everyone really wants them. The question is whether the improvements will be safe AND effective- and until then, we must wait…

  3. I suppose that this is a good idea in theory, but more work is required to ensure the quality of service and make sure that this device does the job it is supposed to do in all sorts of scenarios. I think that safeguards need to be put in place, and specific internet connections (secure, and available). Let’s hope it happens soon!
    Muriel recently posted..French Bashing

    1. That’s my concern, too, Muriel. Having designed many a medical device, I shudder at the thought that some others may “improve” my design- and leave me- and the patient- at fault for their improvements.
      We once considered (ok, more than considered), a battery operated device that would engage if an unauthorized person opened the medical device- melting all the components, so it could no be modified.
      A bit drastic, but it certainly would protect the developers..

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