Dexcom gets FDA approval to calibrate with any meter

[Type1er]

Yea, we can finally calibrate our Dexcom's without a cable!

Here's the news from their press release today:

DexCom™ Receives FDA Approval to Calibrate Its SEVEN™ Continuous Glucose Monitoring System Using Any FDA Cleared Blood Glucose Meter
Approval allows patients to manually enter calibration data directly into the SevenTM

San Diego, CA - November 16, 2007 - DexCom, Inc. (NASDAQ: DXCM) today announced that it has received Food and Drug Administration (FDA) approval to calibrate the SEVENTM, its seven-day continuous glucose monitoring system, using any FDA cleared blood glucose meter. With this approval, patients will be able to calibrate the system without using a connection cable. DexCom expects to launch this feature to new patients near the end of the first quarter of 2008 and upgrade existing patients during the second quarter of 2008.

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It's a shame we'll have to wait until the 2nd quarter of next year, but at least it's in the works. I'm assuming they will have to replace/upgrade the receivers to make it work. I wonder if there'll be any other improvements at the same time?

[JediSkipdogg]

I wonder how much the upgrade will cost since in my opinion, it's just a simple software upgrade. At least Dexcom saw the #1 drawback of their system and decided to change that.

[samsmom]

My son just started on the dex and I can't wait until this upgrade comes out!

shannon

[KEVIN88GT]

how much does the dexcom monitoring system cost (transmitter/sensors)?

[JediSkipdogg]

how much does the dexcom monitoring system cost (transmitter/sensors)?

$800 for the starter kit which includes:

Seven Receiver
Seven Transmitter
DexCom Data Manager® 2 Accessory Software
Receiver Carry Case/Belt Clip
Connection Cable for One Touch® Ultra® Meter
Receiver Charging Cable


Sensors are then $240 for a 4 pack, which last 7 days each, so a one month supply.

You can check their online store out at https://store1.dexcom.com/shop/OA_HTML/ibeCCtpSctDspRte.jsp?section=10020 for more prices.

[KEVIN88GT]

so the down side is that you have to use another stand alone unit instead of the info being sent straight to your pump...and the advantage being that it's cheaper?

I just dont get how the sensors can stay in your body for that long (7) days without possibly causing infection...

[JediSkipdogg]

so the down side is that you have to use another stand alone unit instead of the info being sent straight to your pump...and the advantage being that it's cheaper?

100% Correct

I just dont get how the sensors can stay in your body for that long (7) days without possibly causing infection...

The main reason is because nothing is going into the body. With an insulin pump you are always pumping something into the body, insulin. The addition of something into the body causes the attack to continually occur. Whereas with a CGM sensor there is only an "instantaneous" change into the body, not a continual something new. Therefore the body wants to continually attack the insulin and leave the CGM sensor alone.

[KEVIN88GT]

When you break the biological barrier (skin) and insert a foreign body (even though it's somewhat sterile) wll cause WBC migration to the area....with or without insulin pumping.... It will then ID it as a foreign body and begin a local inflamatory response....

I'm very surprised people keep it in there for that long... do YOU?

[JediSkipdogg]

When you break the biological barrier (skin) and insert a foreign body (even though it's somewhat sterile) wll cause WBC migration to the area....with or without insulin pumping.... It will then ID it as a foreign body and begin a local inflamatory response....

It will, however, the speed is MUCH greater when something else is added to it. A stabbing from a sterile knife let in the thigh will cause no harm if never moved, if the knife is continually moved the the immune system will attack it much faster.

I'm very surprised people keep it in there for that long... do YOU?

I don't CGM yet, so no. I know people that have kept them in for over 14 days, some even 21 days, and they claim no harm, but I wonder what the "safe" time truely is for something like a CGM. No research has been conducted for them staying in longer than 7 days.

[samsmom]

$800 for the starter kit which includes:

Seven Receiver
Seven Transmitter
DexCom Data Manager® 2 Accessory Software
Receiver Carry Case/Belt Clip
Connection Cable for One Touch® Ultra® Meter
Receiver Charging Cable


Sensors are then $240 for a 4 pack, which last 7 days each, so a one month supply.

You can check their online store out at https://store1.dexcom.com/shop/OA_HTML/ibeCCtpSctDspRte.jsp?section=10020 for more prices.

Actually the starter kit is on sale right now for 450 and the sensors are 240 for a 4 pack. We are on day 15 with the 1st sensor.

shannon

[KEVIN88GT]

samsmom how are you finding it's accuracy as compared to the finger sticks.... ?

[NoelD]

When you break the biological barrier (skin) and insert a foreign body (even though it's somewhat sterile) wll cause WBC migration to the area....with or without insulin pumping.... It will then ID it as a foreign body and begin a local inflamatory response....

I'm very surprised people keep it in there for that long... do YOU?

I wear mine for an average of 14 days. The last one, I got 21 days. Never had an infection or any problems. Keep in mind, I wear the Minimed Minilink, but I see no reason why you can't squeeze more out of these either.

[samsmom]

samsmom how are you finding it's accuracy as compared to the finger sticks.... ?

It really has been dead on with Sammy. I was suprised and was all ready for the learning curve between the meter and the dex. No problems at all. It alerted me the other night. Sam was in range at bedtime and then it started alarming saying that he was over 250 and kept alarming...well his site came out and we fixed the problem before he hit 600. His Karate instructors wear the Dex while he is in class and they can tell if he is dropping low or not.

I really did not have much hope that the Dex would be so close to the actual fingersticks, but I was wrong. This may not be others expierences but it has been great for my son.

shannon

[KEVIN88GT]

interesting... what happens if I leave the sensor on the bench and play hockey.... I know I'll be going in and out of range.... will it still work?

[Funnygrl]

interesting... what happens if I leave the sensor on the bench and play hockey.... I know I'll be going in and out of range.... will it still work?
With the 522 you can be out of range for like 40 minutes and it just updates the sensor when you are back in range. After then, you lose data.

[KEVIN88GT]

so I can play hockey... leave my pump on the bench and just go play.... and every time I skate within x amount of feet (whats the actual range?) of the pump it will transmit the glucose reading?

I'm concerned because during VIGOROUS exercise hypo/hyperglycemia is very hard to detect.....(with the sweating/adrenaline/tachycardia)

[JediSkipdogg]

so I can play hockey... leave my pump on the bench and just go play.... and every time I skate within x amount of feet (whats the actual range?) of the pump it will transmit the glucose reading?

SOmeone else would have to answer the time it takes to relay the results back. But my guess is with hockey and just "skating" by the bench there wouldn't be enough time. You'd actually have to sit on the bench for like 5 minutes would be my guess to get 30 minutes worth of results.

[samsmom]

It would probably go out of range if you were out skating. My son is only 6 so he is hardly ever out of range of another adult (who holds the reciever) or he carries it in a pouch.

shannon

[vasuzie]

Yea, we can finally calibrate our Dexcom's without a cable!

Here's the news from their press release today:

DexCom™ Receives FDA Approval to Calibrate Its SEVEN™ Continuous Glucose Monitoring System Using Any FDA Cleared Blood Glucose Meter
Approval allows patients to manually enter calibration data directly into the SevenTM

San Diego, CA - November 16, 2007 - DexCom, Inc. (NASDAQ: DXCM) today announced that it has received Food and Drug Administration (FDA) approval to calibrate the SEVENTM, its seven-day continuous glucose monitoring system, using any FDA cleared blood glucose meter. With this approval, patients will be able to calibrate the system without using a connection cable. DexCom expects to launch this feature to new patients near the end of the first quarter of 2008 and upgrade existing patients during the second quarter of 2008.

---
It's a shame we'll have to wait until the 2nd quarter of next year, but at least it's in the works. I'm assuming they will have to replace/upgrade the receivers to make it work. I wonder if there'll be any other improvements at the same time?
I have used Dexcom for one week, and so far find it basically useless. Readings are about 1 hour behind blood and the constant beepings, for either a high or low that has already been treated, are totally annoying. Am I doing something wrong? The trainer emphasized viewing 'trends' but they are OLD trends. I will speak to tech support tomorrow but expect only the marketing line from them. Anyone have anything to offer?