Many of us living with type 1 diabetes are not thusly Food and Drug Administration compliant when it comes to exploitation our D-tools.

Of course of study there are people tinkering with checkup devices to use them in specific shipway. But even in a day-to-day use context, Here are some examples of how I've in person asleep "hit mark," using products differently than their confirmed instructions per the maker and regulatory regime:

  • Non washing my hands before every fingerstick test with a glucose meter.
  • Not using an alcohol swab when attaching my insulin pump extract rig or injecting insulin.
  • Refilling reservoirs or cartridges instead of replacing the chockful set.
  • Erosion CGM sensors along my arm and other parts of my organic structure than the abdomen, which is what the production's labeled for.
  • Restarting CGM sensors and using them past their labeled article of clothing-clock time.

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

This may fall in industriousness and medical professionals break, but those of us struggling with the realities of this disease know that we do what we have to, right?

In point of fact, these diabetes life hacks that take us off-label are often referred to fondly as "MacGyvering" diabetes, and it is the very baseborn for the whole #WeAreNotWaiting do-it-yourself movement that's inspired information-communion and closed loop groups within our D-Community across the orb.

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

Sportsmanlike because we can, does that forever 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 go a hot push. Different with late models, users have no more been able to restart the G6 sensor after its "hard-shutoff," now at the 10-twenty-four hour period mark.

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

In more shipway, I think we Dexcom users have been spoiled by being able to re-start our previous CGM sensors bygone the initial wear full stop as labelled. The motivating is of course cost nest egg, Oregon to see to it we have enough back-up supplies. Many people now tactile property that if they can't get more than those 10 days, the new G6 will represent unaffordable to them.

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

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

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

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Happening an honorable note, Katie says: "Philosophically, we should be able to live the primary medical exam decisiveness makers for ourselves… with doctors for support. Diabetes particularly involves a dose therapy that has such small tolerances for error, which I call back makes the office true more of a plight. By and magnanimous, I'm in favor hacking (meant in the DIY sense). Until we find the privilege of bread and butter in a government and insurance infrastructure that understands typewrite 1 needs better, hacking helps fill in where the lacking infrastructure is missing. Qualification my kid's life safer is priority first. But, I do think that the definition of 'hacking' is the hardest part of this equation."

Reduced Accuracy and Other Downsides

Are in that location potential downsides to extending CGM wear?

One bountiful nonpareil is G6 clinical data showing that accuracy begins to decay after the best 10 days. There's as wel the fact that the new G6 has whatever unique aspects that tell apart it from what we've had in the ult:

  • doesn't require fingerstick calibrations to correct accuracy
  • is approved for use in making insuling dosing decisions, and
  • is designed to follow interoperable, temporary with insulin pumps and obstructed loop systems and other software that will automate insulin delivery.

In clipped, this system is something completely new, and there could be dangers that we haven't seen with previous CGM generations. There are for certain stories out there of people extending sensor wear for weeks, even more than a month in some cases — where information technology's hard to imagine that the product is hush up acting suitably.

Information technology would alone take a a couple of users dosing insulin off an inaccurate CGM result and subsequently experiencing a stark hypo to raise the red flag. How mightiness Dexcom be called to task? How might the #WeAreNotWaiting community be held apt, if they could be, for providing instructions along going murder-label?

Course, plane when following FDA rules to a T, nothing is 100% safe. But A more and more "ordinary" not-engineer peeps are joining the DIY movement, avoiding mistakes should get over a residential district priority, philosophically speaking.

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

Your Diabetes (Risk Allowance) May Vary, course.

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

Of of course information technology's a personal choice for each of us whether or non to go "off-mark down." And in doing and then, we often find built ways to use these tools, and get a find to testify industriousness what features are most meaningful to us PWDs in the real human race. That's pretty powerful in itself.