First Sensor

I wanted to have more for my first post since Arden started using the DexCom 7+ CGM but a great many things have happen over the past week that all seem to be thwarting my efforts.

Sensor Start at CHOP:

The sensor start went great, I couldn’t be happier that we are patients at CHOP.  Everything was explained clearly, and the support that is offered is more then I need. 

The bad

Issue #1:

The seven plus asked us to enter BG values over and over at calibration, it took multiple attempts for it to accept them and begin working.  That was disconcerting as I am new to all of this and when the product didn’t react as I was told it would I got a bit nervous... but everything seemed to work out and we began getting feedback.

Issue #2:

Since we are OmniPod user Arden is unaccustomed to having to carry something with her on her body.  I have to admit that I am not a fan of Arden being tethered to a device but she seemed to take it all in stride.  It would be nice if it was smaller.

Issue #3:

The range that the receiver has in relation to the transmitter in a word, “stinks”.

Issue #4:

It wasn’t very reassuring when this news hit the papers on the fourth day Arden was wearing the Dex.

The good

Seeing BG trends is an unbelievably useful tool.  In a day I wasn’t sure how I ever lived without it.  It’s so great in fact that it almost outweighs issue#2.

High and low BG alarms are in a word, fantastic!  I feel like I can actually sleep a little sounder then before.

Arden experienced a low on the third day of the sensor and I was able to use the trend arrows to get her back to normal and eliminate the normal rebound high that occurs in those situations.  

The too soon to tell - customer service

Arden’s Dex receiver had a defect in the plastic that covers the screen, one 3 minute phone call later a new one is on the way. Nice!

We had a sensor error last night and DexCom’s 24/7 CSR service was MIA. We had to leave a message and it was never returned which resulted in my having to take off the sensor.  Today Arden is without the CGM because of the inability to communicate with the company.  It should be noted that when I finally got them on the phone 13 hours later I was told that there is no good reason for the phone CSR to not be available and that it won’t happen again - not so nice!

Summation

It’s been a little bumpy but I’m still comfortable saying, “so far, so good, I’m encouraged and looking forward to getting the 2nd sensor on Arden.

more as it comes...

**

The following are archived comments from this post. You can post new comments below.

sisiay

I'm glad you're seeing the benefits of the Dexcom.  It's true, once you know it it feels like to have that graph/arrows, you can't imagine going without it (to the point that some people pay out of pocket for a second device so they don't have "fly blind" during the 2 hour calibration period.  I haven't gone that far yet).
Sorry to hear about your experience with CR.  I've always had wonderful interactions with them, so hopefully that will be the case for you from now on.  I'd never thought so much about the size of the receiver, but I guess I'm a lot bigger than Arden!
I've put a lot of Dex info together athttp://dontfeardiabetes.com/2010/04/dexcom-glucose-common-questions-part-1/ and  http://dontfeardiabetes.com/2010/04/dexcom-questions-part-2-and-how-to-save-money-with-your-dexcom-glucose-monitor/  if you just want an overview of some common issues/concerns w/o going through the whole manual or contacting Dexcom.  Good luck!

Friday, June 4, 2010 - 12:30 PM

Michelle Golladay

I am so glad things are going well with the CGM!  Thank you for sharing!

Friday, June 4, 2010 - 09:19 PM

Scott

Arden's 2nd sensor went on much smoother. More next week. While you're waiting fopr that update, check this out.  

http://web.me.com/skca/Ardens_Day/Daddys_Blog/Entries/2010/6/5_Proud_daddy_post.html

Saturday, June 5, 2010 - 09:08 PM

Emily

So, does this mean no more finger pricks?

Sunday, June 27, 2010 - 07:08 AM

A message from Ardens Mom

DexCom recently received a warning letter from the FDA that got a lot of attention in the diabetes world.  The following is a message from my wife, (and Arden’s mom) Kelly.  Kelly happens to have some expertise in these matters and she wanted to share her thoughts on the letter and what it means.

“RE: FDA Warning Letter to Dexcom 

Hello.  I am Arden's mom.  I have been a Drug Safety Professional for 14+ years. In addition to my BS and MS, I have a Certification in Medical Devices.  I read Dexcom's Warning Letter with my "Mommy" and my "Drug/Device Safety" hat on and I thought I'd add a little perspective here. 

Drug/Device Safety Professional: 

While a Warning Letter from an FDA inspection is never a good thing for any company, they happen more frequently than you'd expect. FDA is tasked with ensuring public safety by ensuring companies have adequate Quality Management Systems in place (this includes Medical Device Reporting of adverse events).  What jumped out at me while reading this Warning Letter, was that for over 2 years, Dexcom had not been forwarding reports of wire fractures to FDA.  How in the world was that missed?? 

The CFR (Code of Federal Regulations - the law that is followed by drug and medical device manufacturers) says that a manufacturer (like Dexcom) has 30 calendar days to forward information to the FDA if the information reasonably suggests that the device may have caused or contributed to a death or serious injury; or if the device has malfunctioned, and if the device were to malfunction in the same way....it would likely cause or contribute to a death or serious injury. So...we know what "death" is, but what is considered to be a "serious injury"?  According to FDA, serious injuries include: life threatening injuries, permanent impairment of a body function or permanent damage to a body structure, or something that requires medical or surgical intervention to prevent permanent impariment of a body function or permanent damage to a body structure. Does our example of a fractured wire qualify as a malfunction that could lead to serious injury if it happens again?  The answer is YES!   

Customer Report 09-5141 in the Warning Letter details a 3-year-old having surgery under general anesthesia to remove the fractured wire.  RED FLAG! - If a Health Care Professional felt that a wire left in the skin of a small child required surgical intervention to remove, that is significant and easily meets FDAs definition of a "reportable MDR"; that is, a malfunction occurred (the fractured wire was left in the skin) and surgical intervention was required to prevent serious injury.  It doesn't get any clearer than this....why wasn't Dexcom forwarding these reports to FDA as they should have been....for over 2 years??  For me, this calls into question Dexcom's Medical Device Reporting System.  I assume Dexcom is working diligently right now on training their staff since this most basic concept was not understood by Dexcom's Safety Team.  It is not uncommon for FDA inspections to spur companies into investing the time and resources needed to create a robust, efficient and compliant Safety Group. 

Mommy: 

Oh no!  My little girl is wearing this thing!!!  Deep breaths....... 

Drug/Device Safety Professional & Mommy: 

Dexcom has some work to do - let's hope they do it because my little girl (a physically tiny 5-year-old) needs their product.  Working in the drug/device world is tough. I sympathize with Dexcom, like managing a child with Type 1, Device Safety can be more of an art than a science. All things considered, the incidence of this happening is relatively low (3 per 10,000 distributed devices) - no device is perfect.  When I think of the options -- use the device with a small possibility of a fractured wire vs not using the device and risking terrible lows and seizures.....I'll use the device and be really careful inserting and removing it!  As parents, we need to weight the benefits and the risks.  The risk of a serious injury is relatively low.....I drive on 287 in NJ everyday...and THAT is risky, but I do it. I am not overly concerned about the Warning Letter. Dexcom has a good product and it's in their best interest to put Corrective Actions and Preventive Actions in place to correct their errors on Medical Device Reporting.  At least it's on everyone's radar now!  And as they say, knowledge is power....and we need that power because to our kids we are SuperHeros!”

You can follow Kelly on Twitter @KellyABenner

Seven Plus Has Arrived

Guess what FedEx brought us today?

I can’t wait for tomorrow!  I’ll be back just as soon as I can to reflect on the process of starting the DexCom Seven Plus!  Check back soon.  Until then... how about another picture?

CGM Class at CHOP

This Thursday Arden and I will be attending a CGM start class at the Children’s Hospital of Philadelphia (CHOP).  

The CHOP CGM staff will make sure that Arden and I understand the device and then they’ll assist us in placing Arden’s first sensor on her abdomen.  A few weeks later I have a follow up appointment to learn how to read and respond to the data that the Seven Plus provides.

I feel extremely fortunate to have quality health insurance and access to a children’s hospital that is so up to date with type I and the technologies that make living with it more tolerable.  I know too many people who are under or uninsured and my heart goes out to them.  I’ve also heard so many crazy stories of endocrinologists that don’t appear to understand type I in any meaningful way... I couldn’t express profoundly enough how much we appreciate CHOP, it’s employees and their dedication to keeping Arden healthy.

With the addition of the DexCom seven plus to Arden’s care plan, I’m expecting to gain even better control of her BGs.  We were already so thrilled with the control that our OmniPodinsulin pump gave us... I’m frankly giddy at the prospect of things getting better.  We have come a long way from taking 10 shots a day.  I’ve been told that there will be an option to integrate the seven plus into OmniPod some time early next year!  On that day... I’ll actually be more excited then when the new iPhone comes out (and I’m traditionally very happy on iPhone day).

**

The following are archived comments from this post. You can post new comments below.

Jim

This is so AWESOME! I am so happy for you and Arden! Good Luck!

Tuesday, May 25, 2010 - 11:19 AM

Barbara (Julia's grandmother)

Understand your excitement -- we, too, are in the process of getting the CGM for Julia.  Of course, a cure would be our #1 Dream Come True.  However,
in the meanwhile, any new products that help us get better control of their blood sugar numbers are welcome.  Enjoy the class and looking forward to hearing about Arden's progress with the CMG.

Wednesday, May 26, 2010 - 09:57 AM

Not that Dino

Not that Dino...  Dino, Arden’s DexCom rep.  Dino is working his (aw hell let’s follow through with this) purple tail off trying to get Arden’s CGM through the health insurance process and things are looking real good!  

I just submitted Arden’s pump records to Dino, they along with Arden’s endo’s prescription should be all we need to seal the deal and start Arden on her continuous glucose monitor - which by all accounts should significantly aid us in keeping her BGs where they should be and stave off frightening lows and life-altering highs.  I’ll talk much more about all of that as this process moves forward.

For now, let’s hear it for Dino!