Many of us living with type 1 diabetes are not so FDA compliant when it comes to using our D-tools.

Of course there are people tinkering with medical devices to use them in unique ways. But even in a day-to-day use context, here are some examples of how I've personally gone “off label,” using products differently than their official instructions per the manufacturer and regulatory authorities:

  • Not washing my hands before every fingerstick test with a glucose meter.
  • Not using an alcohol swab when attaching my insulin pump infusion set or injecting insulin.
  • Refilling reservoirs or cartridges instead of replacing the full set.
  • Wearing CGM sensors on my arm and other parts of my body than the abdomen, which is what the product’s labeled for.
  • Restarting CGM sensors and using them past their labeled wear-time. 

Tack on dozens more examples, and you might have a pretty good picture of the real-world use of many diabetes products.

One definitely unofficial way to wear your CGM sensor

This may give industry and medical professionals pause, but those of us struggling with the realities of this disease know that we do what we have to, right?

In fact, these diabetes life hacks that take us off-label are often referred to fondly as “MacGyvering” diabetes, and it is the very base for the whole #WeAreNotWaiting do-it-yourself movement that’s inspired data-sharing and closed loop groups within our D-Community across the globe.

Yet lately, I have been pondering how far we can safely go “off label” in certain situations, and whether it's wise to promote these behaviors when they fly in the face of how a product is "supposed" to be used.

Just because we can, does that always mean we should?

 

Extending Dexcom G6 Wear

With the recent launch of the Dexcom G6 continuous glucose monitor, the issue of being able to restart the CGM sensors to extend wear has become a hot button. Unlike with previous models, users have no longer been able to restart the G6 sensor after its "hard-shutoff," now at the 10-day mark.

The FDA specified that shutoff, citing new guidelines that state: "The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period."

In many ways, I think we Dexcom users have been spoiled by being able to restart our previous CGM sensors past the initial wear period as labeled. The motivation is of course cost savings, or to ensure we have enough back-up supplies. Many people now feel that if they can’t get more than those 10 days, the new G6 will be unaffordable to them.

It's a legit concern, and I get it, for sure.

That's why some folks have devoted themselves to finding ways to restart the G6, including California D-Mom Katie Disimone, a well-known advocate in the #WeAreNotWaiting community who has created some of the key user documentation for DIY systems.

Katie has just published a new how-to blog post, describing 4 different methods for restarting the Dexcom G6: using the receiver, using the smartphone app, using a specific ResetTransmitter app, or by removing the transmitter from the sensor and then re-attaching it. She's also creating videos showing this restart process, with details on how you can restart both the G5 and G6 models by sticking the receiver in the microwave (!).

Image Source: SeeMyCGM.com

On an ethical note, Katie says: "Philosophically, we should be able to be the primary medical decision makers for ourselves... with doctors for support. Diabetes in particular involves a drug therapy that has such small tolerances for error, which I think makes the situation even more of a quandary. By and large, I'm in favor of hacking (meant in the DIY sense). Until we get the privilege of living in a government and insurance infrastructure that understands type 1 needs better, hacking helps fill in where the lacking infrastructure is missing. Making my kid's life safer is priority number one. But, I do think that the definition of 'hacking' is the hardest part of this equation." 

 

Reduced Accuracy and Other Downsides 

Are there potential downsides to extending CGM wear?

One big one is G6 clinical data showing that accuracy begins to decline after the first 10 days. There's also the fact that the new G6 has some unique aspects that differentiate it from what we've had in the past:

  • doesn’t require fingerstick calibrations to adjust accuracy
  • is approved for use in making insuling dosing decisions, and
  • is designed to be interoperable, working with insulin pumps and closed loop systems and other software that will automate insulin delivery.

In short, this system is something completely new, and there could be dangers that we haven't seen with previous CGM generations. There are certainly stories out there of people extending sensor wear for weeks, even more than a month in some cases -- where it's hard to imagine that the product is still performing suitably.

It would only take a few users dosing insulin off an inaccurate CGM result and subsequently experiencing a severe hypo to raise the red flag. How might Dexcom be called to task? How might the #WeAreNotWaiting community be held liable, if they could be, for providing instructions on going off-label?

Naturally, even when following FDA rules to a T, nothing is 100% safe. But as more and more "ordinary" non-engineer peeps are joining the DIY movement, avoiding mistakes should become a community priority, philosophically speaking.

As someone who's been using Nightscout and xDrip for data-sharing since late 2014, I recognize the benefits of going DIY. Having these tools has saved my life, and given myself and family peace of mind. But I also see the potential risks, and realize that I'm personally not comfortable with taking it past that data-sharing functionality.

Your Diabetes (Risk Tolerance) May Vary, of course.

All I'm saying is that we shouldn't ignore the FDA-flagged risks altogether. We need to exercise caution, and assure that all these published instructions for life hacks come with clear “use at your own risk” warnings.

Of course it's a personal choice for each of us whether or not to go "off-label." And in doing so, we often find improved ways to use these tools, and get a chance to show industry what features are most meaningful to us PWDs in the real world. That's pretty powerful in itself.