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Diabetes Technology Glucose Monitoring
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P050020/S008
10/29/09
180-Day FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories
Alameda, CA
94502 Approval for a modification to the FreeStyle Navigator Continuous Glucose
Monitoring System receiver software. The primary purpose of the new software is to allow users to obtain continuous glucose data as quickly as possible after insertion of the sensor. The new
algorithm changes the calibration time to 1, 2, 10, 24 and 72 hours, with glucose data being
available at one hour. Other changes are the increase to allowable range for glucose calibration,
increase to the allowable glucose rate change and the addition of a calibration lag correction.
Additional changes were made to the Receiver software/User interface; the backlight will now
always be on when the receiver is displaying information, the screen timeout will be 20 seconds and there will be no abandon alarm feature.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm190924.htm

What does this mean? Freestyle says they have no knowledge of this. I think this will be a Great improvement But When Will We See it.

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Feb??? is what I was told.

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what does “and there will be no abandon alarm feature.” mean ?

In talking with the Abbot rep here and a user that was helping with testing was saying that it would be late 2010

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My friend who works for Abbott didn’t have any information (at least that he could pass along to me) about when this upgrade will happen, when the ‘new version’ becomes available for sale, etc. As with all things medical (and related to the FDA) I wouldn’t get too worried about ‘needing’ an upgrade anytime soon. Your current version (same one I use) is still just as accurate as it was before they decided to change the calibration times. They are trying to change the times (in my opinion) to be ‘more competitive’ with the Dex and MM versions.

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Take if from me there is a new freestyle second generation receiver and trans. I am actually doing a clinical trial for it right now and I am using it as I am writing this. Receiver is about 60 to 70 % percent of older one and same for sensors to. Lots of talk about who omnipod is going to get into bed with so tomspeak and dexcom might be one but abbot and freestyle will be the first. I actually am even using the software. Now of course if you call they deny it all but i think that had a lot to do with the supply
disruption so Abbott could get 2 generation going.

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Stephen - thanks for the insight
Can you still mute the alarms ? One description of the new features was confusing
"and there will be no abandon alarm feature."

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Receiver is about 60to 70% percent( WHAT? )Stephen. what is the warm up time? when does your study stop?

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Sorry for being somewhat vague. I had two screaming kids last night. Both receiver and transmitter are 60 to 70 percent smaller. You are prompted to calibrate in one hour not ten, after one hour you start getting your readings liken the first generation you are using. Only draw back is that you do calibrate one more time than you do now but who cares because there is no ten hour wait time. Calibration goes 1,2,10,24,78. My receiver has no mute alarms on it like the older generation but with this model like the one you have to do is disable system alarms and you can leave all alarms as long as you want. In a clinical study you never really known for sure how log they last. I have sensors till mid august and then I guess it ends or it continues, trials changes weekly. The alarm status I have heard is not set in stone on not having it and we haven to fallout pros and cons of the new system and i put in every week as having no mute alarm status as a con and give itbthe worst scale reading. Other than that there really isn’t much more to tell, smaller, same accuracy as first generation and if the FDA would drop their red tape all navigator users I believe would have the chance to be using this. It really isn’t much different than size and the alarm button. Hopenthis helps.
Pump users get omnipod… Best thing ever in therapy if you ask me and this is my third pump

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Is there a dedicated backlight button? Or do you still have to press the lower “side” button before hitting the right “bottom” button to make the light turn on? That annoys me to no end if it wakes me up in the night and I’m just reaching for it on the nightstand. Anyway, info on that functionality would be appreciated! Thanks.

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Hi Steve,
I’ve been waiting before I upgrade my current Deltec Cozmore pump, and I’m particularly interested in your last comment “pump users get opnipod” and an earlier post about the Navigator and pump integration where you mention you are currently using the software in the trial. Does that mean that your trial system has only one receiver now for both the Omni and Navigator? I’ve been on Navigator since March of '08 and have rejected switching to Omni because I just don’t have room on my belt for one more device. I keep my pump in my front pocket and Nav and iPhone on belt which is even a problem when sitting or driving. I’ve told the local Insulet rep that I’m ready for a Omni as soon as there’s integration, even if it means switching to Dexcom, but I love the Nav and I’d prefer to wait for that one.

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Insulet has applied for FDA approval of the integrated PDM/CGM using Dexcom. They are still just “talking” to Abbott right now…
If it were me (assuming your factors of not wanting another box to carry b/c of limited real estate, so to speak), I’d wait on the one with Dex integration, but at this point (as much as I LOVE my navigator), I couldn’t see waiting around for Navi/PDM integration, b/c who knows where those talks are at, and if/when they might try to finally apply to the FDA (which obviously takes time as well), etc…