Navigator Update

[JediSkipdogg]

From Diabetes Mine: Navigator Study: Foiled by the Skin (http://www.diabetesmine.com/2006/11/navigator_study.html)

http://amytenderich.typepad.com/photos/uncategorized/abbott_navigator.jpg

I have seen the future of CGMS, and it looks pretty **** good. OK, I admit, I just caught a glimpse, 'cause I was disqualified for a current study of the Abbott FreeStyle Navigator in the last round due to potential "skin allergies to medical adhesives." Curse those DexCom shower patches (which irritate my skin and made me look iffy here). Curse them!

Anyway, the Navigator is reportedly hekka accurate. Even my new endo says so. (More on that later; and no, I'm not giving out any names). So much more accurate, I hear, that it will blow away existing CGM models. Maybe. Man, I would've liked to take it for a 90-day test drive.

The receiver is certainly smaller than the DexCom's -- a nice compact-like square thingie -- with a FreeStyle blood glucose meter built right in. That will surely make those many daily calibrations a helluvalot less inconvenient.

The sensor, however, is larger and bulkier than DexCom's, more akin to the size of an OmniPod insulin pod, looks like. So that's one disadvantage. But the Navigator sensor will be waterproof, which is HUGE. No need for those irksome shower patches. To make it waterproof, naturally they've got to find the magical medical adhesive that will 1) keep the thing on, even when submerged, and 2) not irritate the heck out of patients' skin. Which brings me back to my disqualification: since my skin reacts quite unhappily to the DexCom shower patch, it seems I may be too sensitive to test adhesives -- at least not if the master plan is for overwhelmingly positive study results.

I had originally reported that Abbott hoped to get the Navigator on the market by the end of this year. But that doesn't seem to be happening now, does it? Frustrating, but I guess I'm not the only one willing to wait a while longer for something that really and truly is hekka accurate!


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All I have to say is Accuracy + Waterproof (without patches) + replaceable batteries = The best **** CGMS around and stupid to go with anyone else.

[Gordonm]

I'm waiting also. Sounds promising.

[Dewey]

I'm also waiting (impatiently, lol). I'd also like to see the release of Lifescan's CGMS system soon. It too, looked extremely promising & more affordable than the rest.

[FrankDr]

I'm also waiting for all the players to get their products out. I'm excited about the Abbott CMGS, but I'll wait and see. With the probability of having to pay for any system out-of-pocket, I need to be fairly certain I'm getting some value for the money.

[Twister212]

All I have to say is Accuracy + Waterproof (without patches) + replaceable batteries...

+doesn't yet exist = doesn't yet exist

[Funnygrl]

All I have to say is Accuracy + Waterproof (without patches) + replaceable batteries...

+doesn't yet exist = doesn't yet exist
It does exist, it's just not for sale.

[JediSkipdogg]

All I have to say is Accuracy + Waterproof (without patches) + replaceable batteries...

+doesn't yet exist = doesn't yet exist

Like FG said.....

The Navigator is proven to be 100% waterproof without ANY patches. It uses the same idea that makes the pumps waterproof, rubber washers and seals. Geee, what a concept, a 2 cent rubber gasket over a battery cap and somehting can be waterproof.

Replacable batteries. That is where the Dexcom and MM both fail. You have to repurchase the entire unit at full price when the battery dies. They won't even give you a discount. That would be like saying your battery in your BG meter is non replaceable and you have to buy a new one each time (ignoring the fact that they are free.)

As for the accuracy. The Navigator has proven many times over that it is nothing short of accurate. They even attempted to go to the FDA saying it was a replacement for fingersticks. Studies have shown highly positive for the Navigator which is one reason it's taking so long for the FDA approval. After they saw the Dexcom and the Guardian/MM version, they didn't think some of the items were possible. It would be like saying you could make a car that gets from Ohio to California in 1 hour, doesn't overheat, and is has such great stability control and navigation that it's impossible to crash. Many would say it's impossible even once someone does do it in 30 years.

[Twister212]

Like FG said.....

The Navigator is proven to be 100% waterproof without ANY patches. It uses the same idea that makes the pumps waterproof, rubber washers and seals. Geee, what a concept, a 2 cent rubber gasket over a battery cap and somehting can be waterproof.

Replacable batteries. That is where the Dexcom and MM both fail. You have to repurchase the entire unit at full price when the battery dies. They won't even give you a discount. That would be like saying your battery in your BG meter is non replaceable and you have to buy a new one each time (ignoring the fact that they are free.)

As for the accuracy. The Navigator has proven many times over that it is nothing short of accurate. They even attempted to go to the FDA saying it was a replacement for fingersticks. Studies have shown highly positive for the Navigator which is one reason it's taking so long for the FDA approval. After they saw the Dexcom and the Guardian/MM version, they didn't think some of the items were possible. It would be like saying you could make a car that gets from Ohio to California in 1 hour, doesn't overheat, and is has such great stability control and navigation that it's impossible to crash. Many would say it's impossible even once someone does do it in 30 years.
No denying it. As soon as a better product comes out, I'll buy it. Until then, I'm getting better and better BGs using my old Model T.

I hope you are right, but I have been watching this stuff "develop" for many years and have seen at least 20 or 30 products that were about to be released as the perfect solution, but ultimately blew up, or were delayed -- sometimes indefinitely. Remember the one from Switzerland that had presented at all of the conferences and was really really accurate. Shortly before its release date, probably in 2004, it turned out that its numbers were fraudulent and the whole house of cards collapsed. I can't even remember their name.

In any event, I too get excited about forthcoming advances, but I get even more excited when a product that can help me reduce my BGs and manage my hypos actually hits the market. Bird in hand, you know.

There are too many reasons why a new product like the navigator can be delayed. Again, I hope the hype is right. But we shouldn't make our plans based on it.

By the way, are there any insiders who read this board who can provide some insight into when the Navigator is going to be released?

[JediSkipdogg]

By the way, are there any insiders who read this board who can provide some insight into when the Navigator is going to be released?

When teh FDA approves it. Which could be 2 minutes ago or 2 years from now. The FDA is as unpredictable as the FCC and the FBI and the FAA. Notice anything in common with those 4? FEDERAL...point said, lol.

[Dewey]

I hope you are right, but I have been watching this stuff "develop" for many years and have seen at least 20 or 30 products that were about to be released as the perfect solution, but ultimately blew up, or were delayed -- sometimes indefinitely. Remember the one from Switzerland that had presented at all of the conferences and was really really accurate. Shortly before its release date, probably in 2004, it turned out that its numbers were fraudulent and the whole house of cards collapsed. I can't even remember their name.

I understand where you're coming from. In my years with Diabetes (almost 25 of them), I've seen many a gadget be talked about, that was never released...:( That can indeed be upsetting, especially to patients who it would truly benefit. I can name the continuous "watch-like" monitor you spoke of: Pendragon. Since there's no active link for the meter currently, I have a pic of the product that I saved:

http://i22.photobucket.com/albums/b325/Dewey_B/PendragonGlucosemeter.jpg?t=1164739130

By the way, are there any insiders who read this board who can provide some insight into when the Navigator is going to be released?
I agree in that I get so excited, only to be let down at times. I truly don't think this cgms system is just hype though. They seem to have clear & definitive plans....but, we all know how the FDA can drag their feet when it comes to Diabetes products...

I'm not an insider, but my endo's office was telling me that this product is supposed to become available the end of this year. I just hope they're right. What an awesome Christmas present that would make! And to whoever said "diamonds were a gal's best friend!" :aetsch: LOL!

[BriOnH]

Once competition heats up hopefully they will have a CGMS that can be calibrated in 5-10 minutes instead of hours. I am all for CGMS but I want to use it only for certain things, not 24/7.

[Dewey]

Once competition heats up hopefully they will have a CGMS that can be calibrated in 5-10 minutes instead of hours. I am all for CGMS but I want to use it only for certain things, not 24/7.

Same here, Brian. I'm so used to doing fingersticks, it's not likely that I'll quit anytime soon, regardless of how accurate the cgms systems may be.

I've also heard (from Animas/Lifescan), that they're going to release a cgms that communicates with the UltraSmart and that will only take moments to calibrate, rather than hours. They also said that because they'll be using micro-needle technology, the sensors can be worn virtually anywhere (i.e. even on the forearm) and that their sensors & system will be more affordable than what's currently available. That would be awesome! I just hope that all this comes to fruition sometime soon...In the meantime (and like many others), I'm still waiting....:toilet:

[BriOnH]

I've also heard (from Animas/Lifescan), that they're going to release a cgms that communicates with the UltraSmart and that will only take moments to calibrate, rather than hours. They also said that because they'll be using micro-needle technology, the sensors can be worn virtually anywhere (i.e. even on the forearm) and that their sensors & system will be more affordable than what's currently available. That would be awesome! I just hope that all this comes to fruition sometime soon...In the meantime (and like many others), I'm still waiting....:toilet:

That's awesome!! That sounds exactly what I am hoping for in a CGMS. That Pendra watch would be effin awesome if it would have hit the market and worked well.

[Twister212]

That's awesome!! That sounds exactly what I am hoping for in a CGMS. That Pendra watch would be effin awesome if it would have hit the market and worked well.
Yes, I was looking forward to the Pendra watch, too. Like the navigator, it received international press for several years leading up to its "launch date" (which was pushed back several times at the last minute). Finally, it turned out that the data was fraudulently compiled and the watch didn't work as advertised. And the company has never been heard from again.

Thats why I use the Dexcom. Because it exists. And it works. Trust me, you'll never miss your finger sticks (although for now, you still have to do them). Its like having a watch. You just glance at it throughout the day and take corrective action.

As some have pointed out, it doesn't do everything one would want it to do (e.g. its not waterproof, it takes a while to calibrate, while generally quite accurate, there are times when its not).

However, it is WAY better than not having one. My hypoglycemic and hyperglycemic incursions have dropped significantly.

Everything else is just quibbling.

As I have said when I wrote on the topic before...I have *no* interest in this company whatsoever. I am just a diabetic who has been waiting for a monitoring solution and is glad that a rudimentary one now exists.

I am still seeking some info on the Abbott Navigator. Nobody has posted anything anywhere, which doesn't seem like a good sign if they are gong to launch by year-end.

[Shotokan]

I would love to have a CGMS accurate enough to refine my basal rates and insulin to carb ratios three or four times a year. I'm not sure I'd want to haul around a receiver and have another thing sticking in me 24/7. I hope they can miniaturize these things like everything else does these days.

[rmccully2000]

Any insider info if Navigator will be discussed? The agenda will be posted on the 5th.

Thanks!
Becky

Advisory Meetings (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=613)

Name of Committee Clinical Chemistry and Clinical Toxicology Devices Panel
Date and Time The meeting will be held on the following dates:
Dec 6, 06 8:00 AM - 4:30 PM

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Related Documents Notice of Meeting: December 6, 2006 Meeting