FDA Approves Dexcom Software with Artificial Pancreas Algorithm

Laddie - Whenever I've had erratic correlation between the finger-sticks and the CGM reading, especially after 24 hours, I've invariably had blood fouling the site. Or you could have bent the sensor enough upon insertion to affect its performance.

Using more frequent calibrations reaches a point of diminishing return fairly quickly. Dexcom will replace the sensor, they're fair. When I've hit bleeders and pulled quickly, Dexcom never gave me any grief. I don't call that often.

I think starting fresh is a better idea. Good luck.

I called Dexcom this morning and they are replacing it plus a couple others that have been bad recently. I started a new receiver and transmitter two weeks ago because I figured my problems might be related to that. Had a great first sensor with the new system, but I pulled it when I did the update because it was about 10 days old. So I just inserted a new sensor from a different lot and I’ll hope for better results.

Laddie, I've had the same trouble you had after downloading the new software. I downloaded the software about 6:00 p.m. last night and my dexcom woke me up at 1:15 am saying I was at 40 and my meter said I was 112. I calibrated and the dexcom came up to 86, but had an arrow straight up. I ended up talking to Dexcom and they weren't really any help, but to tell me to calibrate every 15 minutes for three times and call them back if I continued to have the problem. It got a little better so now I'm just waiting to see how the day goes before calling back. So far, I'm not impressed

After I downloaded the new software, my alerts stopped working. My receiver no longer plays tunes with attentive and hyporepeat settings. I changed the settings to normal to at least try and make it react with a vibrate, but last night I woke up low and it wasn't vibrating either. Mine seems more accurate, but it won't notify me. I contacted Dexcom and they are overnighting me a new one with the new software loaded. I activated this receiver less than a month ago.

I updated my receiver software and I now I went to reconnect to Dexcom Studio and it thinks I am a new patient. Does anyone know if there is a way to merge the new data with the old? I have 2 profiles now with the same identifier, etc. Can't see how to merge the data.

Any ideas?

You can’t merge patient data in Dexcom Studio. I’ve asked them before.



I also download my Dex to Diasend and it does combine all of my data in that program. Unfortunately the CGM reports are not quite as good as those in Studio. Until recently Diasend did not allow USA users to download their Dexcom dats, but now you can. You can also download all of your meters to compare your meter and CGM results. As an Animas pump user, I also download my pump.



I do not know whether you still need to be an Animas user to use Diasend. If you do, this post by Gary Scheiner gives some codes to use as a work around. BTW when Gary wrote that post it was still when USA users couldn’t download their Dexes. You do not have to pretend you’re from another country anymore.

Unfortunately it’s too late to put your old data into Diasend, but this is something you can do in the future. It’s really stupid that Studio doesn’t let you have all of your receivers associated with the same patient.

Wonder when they will have an update for Canadians.

I scoured the Dexcom site and can’t find out if the better accuracy can eliminate the finger stick verification before a pump correction (honestly I have not always done this but I’m currently struggling with radical BG variations and some really high readings)?

Since this update is labeled Artificial Pancreas (AP) then can we start dosing based on the Dexcom alone? I have already been doing this, but I'm wondering if it is now acceptable?

As far as I know, the FDA has not approved it for dosing. In some of the AP trials, they actually use 2 Dexcoms for safety.

As an aside, I am not seeing particularly good results in the few days I have been using the new software...I have seen 20%+ errors. I am going to give it some more time.

+1

I have seen 20%+ errors as well. But I haven't started with a fresh sensor yet with the new software.

...but is there a way to install the old software again (downgrade)?

I have yet to see any great improvement accuracy but I too restarted an existing sensor so maybe with a new sensor the differences will be more obvious.

I'm on day 6 of a sensor using the 505 update. My results have not been excellent until today. First days for me have always been a lot of over and under inaccuracy. This one started very similar and I did five calibrations the first day. I only calibrate when the CGM trace is sideways and I use the average of two fingersticks.


What I've noticed after the first day is that the CGM has been alternating with large percentage errors above the calibration followed by a similar percentage error below. The error oscillated less with each alternation until it homed in on the fingerstick numbers around +/- 5%.

Here's my experience:


The first line on day five was particularly troubling. It occurred while I was sleeping and I just happened to wake up . The sensor read 71 yet the fingerstick revealed a 54, an significant failure of the system. My dog missed it, too :-o.

I’m hoping that future sensors sessions will lock-on like it did at the end of day 5, but sooner. I’ve had many good runs in days 7-14 so I hope the last 24 hours of performance bodes well for the next several days. I’m encourage to read of others, like Dave, that had much better performance sooner. I’ll hold my judgement until I can see a few more sensor runs.

Terry, a third of your fingerstick calibration values are in hypo range.

This is so interesting...I guess the receiver does actually adapt. I noticed when I first started on the G4 how far off it was compared to the 7+, often by 50 or more points, and was actually upset for the first couple of weeks at having had to switch. Since then it's gotten much better (although for me it still seems less accurate than the 7+, but that's beside the point here.)

Can you let us know how your next sensor does? I'll also be interested to hear whether those who initially had issues with the software (Laddie?) have seen improvements over a few days.

This is my experience (sensor-age 15 days patched on my arm's back site and still working fine / updated to fw 505 on day 10):

With the new Software the estimator comes closer to the real bg value.
That means when you measure your bg with a meter 40min after a meal
and it shows you a 220mg/dl, the Dexcom will be at 200 - sometimes the
Dexcom's estimator is too fast and it shows me a 240mg/dl ;).
With the old software, i think the value would be 160-180. With the new
algorithm, the trend graph doesn't look smooth. You have to adapt to the
trend arrows. Sometimes they act aggressively because auf speed.

I've found that my body starts to respond with adrenaline and other counter-regulatory hormones when my glucose drops below 65 mg/dl (3.6 mmol/L). That's my threshold of hypoglycemia. By that personal standard, I only count one of the above fingerstick calibrations, the 54 mg/dl (3 mmol/L) fingerstick, as hypoglycemic.

I know that the American Diabetes Association defines hypoglycemia as anything below 70 mg/dl (3.9 mmol/L). By that standard I show 3 of 16 values, or less than one fourth, as hypoglycemic. How did you count a third?

What i mean is the dexcom doesn't work well with such
low values. Especially calibrations.