On a somewhat related note, I have been thinking about returning to an insulin pump after many years MDI. I stopped using Medtronic because I developed an allergy to the adhesive and I was using too much insulin to last three days. I had to change sites every two days due to pain at the site. Now that I have cut back dramatically on my insulin use, I am interested in trying a closed loop system with Dexcom. I would be interested in knowing what my options are and if anyone has had better luck with adhesives other than Medtronic. I have not developed an allergy to the Dexcom adhesive. I also think I would do better with a pump I can wear on my arm which is not really possible with tubing like Medtronic has. I appreciate all input.
Thanks for this. Of course I’d rather have fewer sensor changes, all else being equal. The footnotes are important, though, particularly this:
“A study was conducted to assess the sensor life where 73.9% of sensors lasted the full 15 days. When using the product per package labeling, approximately 26% of sensors may not last for the full 15 days.”
I don’t know what percentage of current sensors fail, so I can’t make the comparison, but these numbers are worth bearing in mind when complaining about failed sensors. I share the annoyance when that happens (and I’ve voiced it here a lot). But manufacturers and regulators may have different notions of what “acceptable” failure rates look like than we do.
Overall the G7 has been much more reliable for me than the G6. I did find I had to switch to the back of the upper arm from my preferred thigh position but the sensors are much more reliable there. I also learned that 90% of the time I get a “failed sensor” issue at startup, it works for the full duration (currently 10 days) if I just restart it. The G7 sensors still have issues at times but the good far outweighs the bad in my experience; the trend information is invaluable. I am skeptical about them lasting 15 days but excited at the prospect of fewer site changes.
Thanks for the post! Knew it had been applied for. Am concerned about the stats, seems they’re just re branding the G7 for a longer duration and hoping it takes! I’ve put it on my discussion list for my Endo in May, but Lord knows if he’ll have any better info than this. I wouldn’t mind having it for the longer duration if it actually works, but question the stats. We’ll see…,
For people on Medicare it may only be an advantage if they allow for an extra 25% of sensors to account for failures. Currently they allow only a 90 day supply to be ordered when you are down to a 10 day supply. There is no allowance for if you have to remove a sensor for an MRI, or if it falls off. So they would have to allow for that 25% failure rate, or not.
Mike
So I’m actually ok with the 25% or so that will fail after day 10 if they continue their policy of replacing sensors that fail early. After a year or so in guessing I could get a few months ahead on these new 15 day sensors. If I lost my insurance or there was some kind of shortage this would be some piece of mind.
I’ve had zero trouble getting replacements for sensors that fail on day 8 and 9 over the last year or two.
I also really hate the first 48 hours of a sensor because of erratic readings. I do TONS of fingersticks. The first overnight I’m awoken with low alerts from my phone and pump every hour or so even with a 12 hour presoak. I dramatically lower my carbs and stop working out. I think if this 48 hours was cut to twice a month instead of 3 times a month I would be a little less cranky.
This is deemed a significant change in the device’s intended use so Dexcom will have had to prove that the extended life of the sensor still meets specifications and demonstrates equivalent performance criteria compared to the predicate (original G7). What may be more difficult to discern is whether any design changes were necessary to support the 15 day use
@funk I think your comment and my concern address the same thing, ie a failure to achieve the 15-day time of about 26% of the sensors (my reading of the info…am I wrong?) seems very high!
A local (Seattle area) clinic was enrolling Type 1’s in a current “Dexcom G7 device trial”. I found out a little bit about it…wear 6 or 7 G7 sensors in different spots on your arms/body for 15 days, doing 9 fingersticks daily, visiting the clinic a few times. All while continuing with your own personal CGM if using one. The study was enrolling during March (a few weeks ago) but I was out of town on a trip so was too late to sign up.
My guess is they are trying to get a better MARD statistic for a variety of placements. I would think they have to improve the sensor quality somehow to improve on that sensor longevity after Day 10 and to make that MARD improvement but no inside info here, just a guess.