THE STORY OF ONE FAMILY'S JOURNEY WITH TYPE 1 DIABETES AND CELIAC DISEASE.
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Showing posts with label dexcom. Show all posts
Showing posts with label dexcom. Show all posts

Tuesday, February 22, 2011

Dexcom Review -- 2 Months Into the Game.

I wrote about our past CGM experience...and I shared my reservations about trying the CGM again...then I shared a review of our week long Dexcom trial.

If you've been reading Candy Hearts for awhile, then you already know that we completed the insurance process and obtained a Dexcom SEVEN PLUS of our own just before Christmas.  In the time since, I've discussed the Super Bolus and our shark's teeth phenomena.

It's been 2 months now.  Most of the time Dex and I get along okay.  Sometimes we don't.  But, at any rate, here's a few things I've learned:

1) Each sensor is a new ballgame. This is why I can't trust it. I feel like I have to build a new relationship every time we insert a new sensor.  Relationship drama is the WORST!

2) In my opinion, each sensor needs a 48 hour grace period before I rip into it about being unreliable. I think it takes time for it to "settle in" and start doing it's thing.

3) Her arms work better than her tummy. I realize it's only FDA approved for her belly, but I think she has more interstitial fluid in her arms. Not only that, when she lays on her tummy at night, it disperses the fluid under pressure and we end up with crazy overnight graphs.

4) It CAN be calibrated TOO MUCH! I had no idea! We were entering every number, but then I read that you were only SUPPOSED to enter a number if it's more than 20% off (actual BG divided by 5) OR if it prompts you to. The sensors and I are getting along much better now that we've been sticking to that rule.

5) The number is usually useless for rapid swings in either direction. The arrows, however, are not. If she's feeling low, I test and treat just like we did before Dex came along. 15 minutes later, I can retest and, while the numbers might still be inconsistent, the arrows usually point me in the right direction -- double arrows down turns into one arrow down turns into a slanted arrow down, etc... I do feel like I can use the arrows confidently to help me gauge what direction things are moving and whether or not additional treatment is necessary.

6) When placing the sensor (which, btw, I have never done -- Hubby handles all that jazz), it's important to get a good squeeze of fat and lift it as high as you comfortably can (again, we're using arms for Dex) to make sure the sensor doesn't get inserted to deep.

7) There are times that I actually **LIKE** having 2 devices...
** The first was when we took a New Year's Day trip to play in the snow.  It was about a 3.5 hour drive, and I sat up front with the Ping remote and Dexcom receiver.  It was SAWEET!  I could tell what was going on in the seat behind me plus point and shoot the remote over my head to give insulin!  
** I also appreciate being able to keep the remote on the charger at night.  It's SO NICE not to have to rumble around looking for her pump to see the CGM.  A quick glance is all we need for extra reassurance at night.
 8)  Each sensor consistently lasts between 10 - 14 days.  They may go longer, but we remove it when she starts to complain of itching.  We have yet to remove a sensor at the 7 day mark. Thus far, we just restart the sensor, wait for the 2 hour start up period, enter 2 BG's, and press on :)

On a side note, here's where I stand with those reservations I mentioned earlier:

Insurance:  So far, we haven't had a problem.  They approved the system and the sensor refills.  That being said, we haven't actually received our first refill order, so I do have to admit that I'm holding my breath a little.

Real Estate:  We're using her arms exclusively for CGM sites.  She never liked wearing pump sites in her arms, so it seems to be working well for now.  We rotate her pump sites between her bum and tummy and the CGM sites from one arm to the next.

Hypoglycemia Awareness:  She continues to feels her lows somewhere around the 60's.  That being said, her lows do NOT wake her up at night.  She didn't wake up from lows before Dexcom either, so we remain pretty vigilant at night.

Technology Updates: We're eagerly anticipating the Animas/Dex combo, but do not expect to see it anytime soon.  After reading this information, we decided to go ahead and renew her pump warranty and will play the rest by ear.  If we have to pay out of pocket for an upgrade later, we'll cross that bridge when we come to it.  Keeping her current pump under warranty is something that we just didn't want to risk.  As for other pump options, we can't base our decisions on what might or might not be part of the future in pump therapy.  We're happy with Animas today, and will just see where this road takes us tomorrow.

Click HERE to read other CGM posts at Candy Hearts.

PS -- If you have concerns about skin sensitivity and adhesion issues, Lorraine has a great post that addresses those concerns HERE.

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Wednesday, January 19, 2011

90 - 105 - 125 - 117

The numbers that make a mother's Candy Heart sing.
All is well.
Blissfully well.

These beautifully patterned numbers can only mean one thing:
SuperBolus success.
combined with
Lunch spike striked.

Victory.
Glory.
DEFEAT!

So, raise that glass of Crystal Light, my dear child.
And then hand over Dexcom so I can bask in this momentary conquest.

I can just see the picture now:
A beautiful 12 hour straight line...topped off with a stable arrow indicating perfect continuity...

It will radiate distinction.
It will glow.
IT.  WILL.  BE.  GRAND!


Or not.

What     is     THAT?

Shark's teeth?
A spike over 250 after breakfast?
77 with an arrow trending downward?
And what's up with the questionable double spike thing-a-ma-jig after lunch?

REALLY?

You know....
Sometimes ignorance really is bliss.

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Monday, December 13, 2010

DexCom CEO Discusses Q3 2010 Results

First of all, don't ask me what the heck this is.  I'm not a financial guru.  I know nothing about stocks, bonds, and trading.  


All I know is that our Animas warranty is set to expire soon. 


Like...


REAL soon.


I started thinking about the fact that I'd better get on the ball to get her renewal process rolling after the Ping remote fell out of her diabetes bag yesterday afternoon...


Well darn.


That ominous streak down the center of Santa-Ping is NOT good.  


Sigh.


At least we can bolus from the pump itself so she doesn't have to go back to shots until the replacement arrives.  (ETA:  Wednesday, btw)  But still.  I've gotten lazy in my old age and I LOVE THAT STINKIN' REMOTE!


OH, yeah....back to the Dexcom thing I'm posting about today...


So, ANYway...before I make the call to get a new pump warranty, I wanted to make sure that I haven't missed anything about the release of the Animas/Dex combo pump.  You know...brush up...Google around a little.


And that's how I found THIS...


Apparently it's a transcript of the Dexcom 3rd Quarter 2010 earnings conference call, dated 11/9/10.


Hmmmm....very interesting....


It starts off with a little introduction followed by a cautionary statement basically stating that the statements made are "forward-looking" and essentially subject to change.


It goes on to give a financial statement about revenues...yada, yada, yada...  By the way, it's worth mentioning the fact that this section reports Flextronics (the contract manufacturer) is relocating the Dexcom production line from California to China...as a result, the internal sensor manufacturing line is expected to be shutdown for 2 weeks during the 1st Quarter of 2011.  It looks like they're increasing sensor production during the 4th Quarter of 2010 to prepare for this shutdown. 


Moving on...


The next section talks about the fact that the FDA is "undergoing sweeping changes to its review and approval policies and procedures, and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products.


and


"As a result, the medical device industry is in the midst of a sudden and dramatic shift in the requirements for product approvals. This has created an atmosphere of unpredictability and uncertainty surrounding the submissions process and in many instances it is not altogether clear what the agency will require or expect of new submissions, particularly for companies seeking clearance under the 510(k) regime."


Then they begin to address the Gen4 sensor, stating..."In fact, we believe we have identified an opportunity to accelerate review of our next-generation hardware platform as part of an amended Gen4 filing. Specifically, when we conducted the pivotal trial to support our Gen4 sensor filing, our next-generation hardware platform, which includes a smaller receiver form factor with a color screen and a modified transmitter with more robust transmission frequency, were still in the development stage. Due primarily to the manufacturability and scalability benefits provided by the Gen4 sensor, we elected to move forward with the trial and subsequent filing of the Gen4 sensor paired with our legacy hardware platform. Now, as part of a comprehensive response to the FDA, we intend to include not only the additional information requested by the agency concerning the Gen4 sensor, we expect to include data to support approval of our next-generation hardware platform. This would enable us to launch a more robust fourth generation system."


And this section also says "So while our timeline for launching the Gen4 system will be slightly delayed, through an open and transparent dialog with the agency, we believe we will be in a position to provide the additional information requested of us regarding the Gen4 sensor, and at the same time, accelerate review of our next-generation hardware platform, which would position us to launch yet another best-in-class CGM system during the second half of the year."


Then we get to the nitty gritty...


"Shifting to our combination product, the regulatory uncertainty facing the insulin pump market is particularly daunting. Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear.
This changing landscape will certainly impact approval timelines in the United States for integrated systems with Animas and Insulet as I suspect it will for Medtronic and the numerous small privately funded pump companies seeking to bring new pump products to market.
As you know, we filed a PMA supplement seeking approval of an integrated insulin pump continuous glucose monitoring system with Insulet Corporation earlier this year. We've now received a formal written response from the agency regarding our submission, and much like the response to our Gen4 submission, the FDA has requested substantial additional information including additional human clinical trials data concerning the safety of insulin delivery by the system.
We are working with Insulet to formulate an appropriate response to the agency, but due to the time and expense associated with conducting an additional clinical trial, Insulet is evaluating whether it makes sense to move forward with the existing combination product that uses our SEVEN Plus, and the current OmniPod, or whether it would be more beneficial for potential patients to incorporate our current or future generation CGM technology into Insulet's next-generation OmniPod platform and conduct a more expansive trial as requested by FDA.
We are also exploring the opportunity to submit an IDE relating to the existing combination product for research purposes, which would allow us use of the system in various artificial pancreas studies in the near term. With respect to our integrated system with Animas Corporation, we are pleased to report that we have concluded development, and are nearing completion of final systems testing.
However, in light of the uncertain clinical and regulatory landscape I just mentioned, and based on our review of the additional information requested by FDA in response to our PMA supplement filing with our combination product with Insulet, we are seeking a pre-IDE meeting with the agency to determine the best clinical path to support approval of our combination product with Animas in the United States.
While this path will not enable us to file a PMA supplement for the Animas system this calendar year, we believe that working on a collaborative basis with FDA prior to conducting a human clinical study is the most prudent course of action from a timing perspective, and certainly the most cost-effective way to proceed."

In the Q&A section, it would appear that Animas is contracted to release a combo product with the newest technology, currently awaiting FDA approval: the Gen4 sensor.  Obviously, that sensor needs to finish the FDA approval process and then the combo pump will have to go through the FDA process before it hits the market.

There's further discussion about Insulet's combo product with the Dexcom SEVEN Plus that is currently awaiting FDA approval.  The discussion seems to be whether or not Insulet is going to release it or wait to upgrade the technology, stating "Our current contract does not provide for access to our future technologies, but certainly we're open to discussing that with them." It would appear that this is a decision that Insulet needs to make.  The commenter does state "I'll just tell you my opinion is if I were driving the ship, I'd be launching with the SEVEN Plus, because I would certainly want to have some cannibalization going on of the existing pump combo by Medtronic. But I don't make that decision."

Anyway, I just found it all very interesting.  

And, in case you're wondering, I'll be calling to start the paperwork process to get our Animas pump warranty renewed ASAP.

Here's the link, once again, so you can read it all for yourself...

DexCom CEO Discusses Q3 2010 Results - Earnings Call Transcript

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Wednesday, December 8, 2010

The Review: Our Dexcom Trial

The best you can hope for in this game are effective TOOLS to help you tame the beast. For some people insulin via syringe is an effective tool. For others, insulin pens or pumps. For some, logging every number, carb count, and dose by hand; while computerized logging systems work better for others.  Some people need a total carb number from the label; others need a glycemic index value. Some people use food scales; others don't see a need. Some people don't mind sugar tablets; others would rather be low than chew on one.

Get the drift?

First of all, Sugar did NOT want to try the CGM.  We went round and round in the car about putting on EMLA and she got REALLY worked up...if it wasn't for the fact that our Dexcom trial coincided with her regular A1c visit, I might have turned the car around.  Then I remembered that her friend, J, had JUST finished her Dexcom trial the day before.  After a text exchange with with J's mom, Sugar was on the phone to chat with J about her experience during the car ride.

J and Sugar have known each other for several years...first Sugar started the pump and then J was open to considering it.  First J switched from Cozmo to Animas and then Sugar was willing to consider the same switch (after Cozmo announced they were stopping production of their insulin pumps).  In my heart, I knew if anyone could calm Sugar's anxiety about trying the CGM again, J could.
J and Sugar, 2006
J and Sugar, 2008
J and Sugar, Spring 2010
J and Sugar, Summer 2010
Sugar on the phone with J
And she did!!!!  Thank you, J!

I had EMLA on the back of her arm, but our CDE explained that the sensor was only FDA approved for placement on the abdomen.  She wigged out a little when she heard that (she doesn't even like pump sites on her tummy), but did awesome.  I was very proud of her, because I know she was comparing this experience to our last CGM experience.

Anyway, the Dexcom unit itself was VERY easy to navigate.  Sugar (age 7 1/2 years) was able to enter all the data by herself.  She really enjoyed the independence and we enjoyed witnessing her take on the responsibility with such amazing confidence.

The first thing you should know about our trial is that I turned all the alarms OFF.  I couldn't handle them.  There's, like, an alarm for EVERYTHING:  "She's rising."  Thank you...yes, I know she has Type 1 Diabetes and her body does not produce insulin.  "She's over 300 now."  Thank you.  "She's dropping."  Thank you.  "She's 80."  Thank you.  "She's 55." Thank you.

ENOUGH ALREADY!  

Dexcom allows all of the alarms to be disabled, EXCEPT the low alarm that alerts when it senses a glucose level of 55.  

Fair enough. 

The second thing I should mention is that the sensor STAYED ON.  That's always a plus.  We didn't have the same luck when we tried the Navigator a couple years back.  I didn't put anything around the edges.  I didn't cover it.  I didn't sprinkle fairy dust on it.  The adhesive just worked without causing skin irritation.  Plain and simple....and pleasant :)

For the first 2 days, the sensor seemed off by 50+ points with intermittent periods of accuracy.  I was prepared for this after reading that sensors can take a couple days to "settle in" (Kudos to the DOC!!).  I tried to pay closer attention to the arrows during this time frame, and found them to be very accurate as far as predicting which direction her numbers were trending.  Once the sensor "settled", most of the finger sticks and CGM readings were within 10 - 20 points of each other.  Throughout our week long trial, the arrows remained consistently accurate.  

When her blood sugar topped 300, the number accuracy seemed to falter a bit.   When she was low, however, Dex was ON IT.  If I had to choose between one or the other, I'd choose to have a CGM on target with lows.

On one occasion, I quickly treated a fingerstick of 50-something during a birthday party at the park, and then let her run back to take her place in the game.  I ASSumed (dumb, I know) that the juice box would take care of it since she didn't have any IOB.  Five minutes later she was back, telling me that Dex wouldn't stop buzzing.  Fingerstick = 46.  Thanks, Dex.

I didn't feel as though we tested less...but I didn't feel we tested more either.  I also didn't feel as though I could sleep easier.  Admittedly, that could be a trust issue that develops over time. It took me awhile to trust her insulin pump as well.  That being said, there was one evening I fell asleep after bolusing for a late snack around 9 pm, and forgot to set an alarm.  The next thing I knew it was 5:30 am...I rushed to her room in a complete state of panic!!!! Fingerstick 112.  Dex 113 with a beautiful 6 hour flat line.   Nice.

I can't say I was surprised by anything I saw on her graphs.  I didn't *like* seeing the HUGE spikes, but it's not like I didn't know they existed.  There's something serene about living in the world of not being able to actually SEE those ugly mountains.  She seemed to spike to the 220's - 230's most of the time after eating.  When she spiked higher (sometimes MUCH higher), I almost wanted to throw up.  It wasn't pretty.

Unfortunately, I do feel as though my concern about Sugar discounting her low symptoms and, instead, relying on Dex to alert her was somewhat legitimate.  We seemed to have more lows than we've had in a long time.  I really have no idea why that would be, but, in the beginning, she seemed to catch them (as usual) in the 60's within seconds of being buzzed by Dex.  As the week went on, however, it seemed as though she wasn't catching them at all.

During the last 48 hours of our trial, she had lows to the 40's TWICE while at school and didn't acknowledge feeling anything at all until the nurse pointed out that Dex was consistent with her fingerstick.  After returning Dex to the endo's office, she dropped to THIRTY-EIGHT (38) before coming to tell me she thought she might need help, but wasn't sure.   This many lows, combined with this level of unawareness is VERY unusual for Sugar...makes me wonder....has she been randomly dropping all along, but we've been catching them with a snack before we realized it?  OR are these lows a residual effect from setting adjustments we made 2 weeks ago when she was growing...sometimes it's normal to need to back off after a major overhaul like the one we just had.  OR is it all just a crazy fluke because diabetes doesn't play fair?

To be objective, however, I want to reiterate that I **DID NOT** have the alarms turned on. For each of those lows, there would have been a predictive alarm alerting when she was at 80 (or 90 - or whatever we choose to set it at) and dropping.  I fully recognize that, had the alarm been activated, we probably would have caught the lows and corrected them sooner.

Anyway, we filled out the paperwork.  But....I'm not exactly sure where we're going with it. I do see the value it might offer when she's throwing random highs and I can tell a storm is stirring.  Until the other day, I completely trusted that Sugar was capable of catching her lows.  Today I don't have the same confidence.  If this unawareness doesn't correct itself soon, I'll be desperate to slap it back on with all the low the alarms set to blare!

At any rate, after removing the sensor, we were both curious as to what it looks like.  I took a couple pics, just in case you're curious too...


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While I'm happy to share our experiences with what works, and what doesn't work, for the management of Type 1 Diabetes and Celiac Disease in our house, please do not mistake anything you read here for medical advice. Decisions regarding your/your child's health care should be made only with the assistance of your medical care team. Use any information from this blog at your own risk.