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.

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

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...

Here's some other CGM posts from around the DOC:

Houston We Have a Problem

Sweet to the Soul

Sweet to the Soul

My Life With the Superhero and the Princess

My Life With the Superhero and the Princess

The Princess and The Pump

The Princess and The Pump

The Great CGM Debate

Maybe I suffered some sort of PTSD after our CGM experience in Spring 2009?

I don't know.

Perhaps I was SO INCREDIBLY let down?  Or traumatized from seeing her struggle with tears in her eyes because she perceived we were hurting her?  Consumed with guilt for forcing the issue?  Frustrated that we didn't have an opportunity to trial it first and, instead, had to use our ONE AND ONLY CGM approval for the LIFETIME of the policy?  Ticked off at the school situation and the fact that IT was the reason we were even considering a CGM in the first place?

Whatever it is...or was...I've been left with some serious CGM reservations.

I'm reserving my "position statement" regarding the Dexcom 7 Plus until after our trial is over (Tues, 12/7/10).  I want to give a complete assessment of our entire experience.  My opinion is subject to change with any given blood sugar reading (as it always seems to be, generally speaking), so it's important that I figure out how **WE** feel about it overall before I try to write up an honest post regarding our point-of-view.

In the meantime, however, I want to be honest about some of the CGM concerns I have. Admittedly, I'm hoping the vast knowledge and experience from my readership -- ESPECIALLY PWD'S WHO HAVE FIRST HAND CGM EXPERIENCE -- will help me put some of them to rest.

Now don't laugh...but...in no particular order...here goes...

1)    INSURANCE!!!  What if our new policy pulls the same thing?  Only ONE per lifetime and NO SENSOR REFILLS?  I should note that our old policy didn't inform us up front about the sensor issue.  We knew it would be the only CGM device they would pay for...but we didn't find out they wouldn't refill sensors until after the fact.  We've since switched insurance companies, but not employers.  Thus far, all the fine print appears to be the same...meaning the level of benefit has not changed at all....we may only get ONE shot at this and then we could end up fighting for sensors to continue using it.


2)     REAL ESTATE!!!  She's a kid who has already been pumping for 4 years.  Her subcutaneous tissue needs to continue absorbing subcutaneous insulin for a LONG time yet to come.  While we're faithful about rotating sites, having ANOTHER apparatus to rotate means using twice the amount of real estate.  I don't want to risk infections and/or scar tissue to precious areas that could be used for insulin administration later.  


3)     HYPOGLYCEMIA AWARENESS!!!  It's taken a few years, but Sugar is able to detect her lows REALLY well.  There are times, however, that she isn't exactly sure.  She just feels as though something is wrong.  Sometimes she thinks she's low because she's feeling very hungry, or anxious, or she's actually high.  She **HATES** interrupting life to deal with diabetes - ESPECIALLY if she's playing with a friend. I'm convinced there are times she tries to talk herself out of feeling low, because she just doesn't want to stop playing (can't really say that I blame her.) I'm worried that she'll stop paying attention to her body's cues and, instead, rely on the CGM to let her know when she should seek help.  I'll be honest...I'm REALLY afraid of this one.  If I were putting this list in any particular order, I'd probably slap this concern at the top.


4)     TECHNOLOGY UPDATES!!!   Sugar's current pump warranty expires in 1/11.  Since she started pumping in 2007, I've tried to stay pretty current with pump technology.  While writing this post, I revisited some websites to make sure my knowledge base was still current regarding the pump features I value most.  The only pump I am interested in learning more about would be the tubeless Solo -- which was SUPPOSED to be here by now...but, instead, was acquired by Roche in 5/10 and is now going to begin with a limited release in the Netherlands sometime in 2011 (well, or so they say, anyway).  So, that means the Solo is out as an option for us here, in the USA.  


ANYway, I have full confidence that Animas is the right pump for Sugar and plan to renew with them for the next 4 years.  Fine.  Except...WHEN is the Animas/Dex combo pump going to be released?  If you've been around D technology for any amount of time, you probably already know not to believe anything until you SEE it.  (If you're a newbie...there ya go...BELIEVE IT WHEN YOU SEE IT!!!)  New rumors seem to surface about technology all the time.  It's not IMPOSSIBLE that Animas will release their new pump before 1/11...but it's HIGHLY unlikely.  Getting new stuff approved through the FDA takes forEVer...and, now that the FDA wants MORE control, the whole waiting game is just getting longer.


SO....that loops me back to the first concern I mentioned with the insurance hoopla.  If, indeed, they will only pay for ONE CGM, then.....do we want it now or later?

I guess that's it for now.  There are some other things swirling around in my brain, but I'm going to bed.  My brain is just going to have to rest whether it wants to or not....

Besides, the Great CGM Debate will still be here in the morning.

Goodnight...

(Postscript -- Here's the review of our CGM Trial that followed.)

Our First CGM Story

In the Spring of 2008, this press release announced that Sugar's insulin pump at the time (Cozmo) had partnered with a continuous glucose monitoring system (Navigator).  During that same time, we were preparing to end Sugar's first year of pre-school after a rough start followed by a pretty rocky school year.

Once Fall arrived, Sugar began kindergarten at the same school.  She was unable to distinguish low blood sugars from anxiety and hunger, and spent a great deal of time going to the Health Office.  The nurse was very bothered by her frequent visits, and Sugar began feeling afraid when she felt she needed to go to the office for a blood sugar check.  She had low blood sugars in the 20's twice after trying to avoid a trip to the Health Office because she didn't want the nurse to get angry with her.  Then she had an episode of high blood sugar ("HI") that required an injection until someone could get to the school to change the site, and the nurse refused to administer the insulin, despite the fact that a parent confirmed it was the correct dose.  She was uncomfortable because she hadn't ever administered a dose that high before.  (Mind you, it was also the first time she needed to correct "HI" at school!!!)  Instead of administering the insulin she needed via injection, the nurse sat her at a table in the Health Office and had her eat an 80 (!!!!) carb lunch while waiting for a parent to arrive.

It was a mess!!!!!!

After that episode, I decided it was time to try a continuous glucose monitor (CGM).  The choice was obvious since Cozmo had established a partnership with the Navigator.  After a few months of insurance ramblings, and A LOT of patience, we received her Navigator in the Spring of 2009.

Now, keep in mind, that it was perfectly commonplace to hear about insurance fights and whatnot when trying to get a CGM covered.  Additionally, since it wasn't approved for use in a child, we had to argue that battle as well.  Our endocrinologist was on maternity leave and the doctor who saw us in her absence was adamant that he'd give us the order, but we could not - under any circumstance - call his staff for help with it.  They hadn't been trained and didn't have any precious time to spend trying to answer my questions.  There were no such thing as trials.  You either got it or you didn't.  Period.  Our insurance at the time agreed to pay for ONE CGM during the LIFETIME of our policy.

Suffice to say that GETTING the CGM took some time.  By the time it was actually in our possession, I had masterminded up a scenario of how wonderful it was going to be.  In my mind, she would be able to find immediate reassurance that her instinct to request a blood sugar check was correct...it would help me identify patterns of lows and highs to assist with adjusting her pump settings...we would **SLEEP** at night knowing that something was keeping tabs on her numbers and would alert us if there was trouble.

IT WAS GOING TO BE GLORIOUS!!!!

  

Not.

To make a long story short...The insertion was incredibly traumatic and complicated.  We had to cut the dressing in a special way for extra adhesive.  After the sensor was placed (which she screamed through every time, despite EMLA), we had to keep dabbing at a little window until it stopped bleeding.  It NEVER stayed on for more than 48 hours because the adhesive would fail, and we NEVER had readings consistent enough to trust.  There was a **TEN** hour start up window -- during which time, she was ideally not supposed to consume any carbs.  AFTER 10 hours, sometimes it would tell you start over with a new sensor.  You had to calibrate according to IT'S terms at predetermined time intervals.  For this reason, I had to make all sorts of special accommodations so I could go to the school and wait for it to demand a blood sugar --around the time I guessed it was going to feel like it.  I was going crazy doing everything I could to make it work.  We were blowing through test strips like candy trying to get it calibrated.  It was throwing information at me that I wasn't prepared to process.  She was incredibly frustrated with the entire mess.  She hated it.  She said it hurt.  She wanted to throw the whole thing in the trash!!!!  After about 4 weeks of insanity, our insurance company announced they would not refill the sensors...at that point, we had to decide if it was worth the fight.

And we decided it wasn't.  Even if we DID figure out how to use the stinkin' thing correctly (and get it to stay on!!!!), our insurance wasn't going to pay for the sensors.  What was the point?  With that, we threw in the towel, took it off, and it's been sitting in the closet ever since.

Our experience left a HORRIBLE taste in my mouth, and a FEAR inside Sugar's heart.  It's taken a long time to mumble the letters C-G-M without feeling anxious.

Through the DOC, I've learned more about CGM experiences. I've paid close attention to success stories.  I've hailed victory with parents who have had positive CGM adventures.  I've cheered over 3 and 6 hour windows with a nice fine line in range.

But I HAVE NOT been able to bring myself to try it again.

So, what's next?

11/30/10 Sporting her Talleygear Tummietote and trial Dexcom sensor

STAY TUNED!

Animas PING - Our Pump Choice

I run into this question just about every other day.  It is, by far, THE most common inquiry I get from the diabetes social network realm (aka - Diabetes Online Community ... aka The DOC).  Honestly, I don't mind answering over and over and over again!  The problem I run into is that LIFE often prevents me from returning e-mails/FB messages as promptly as I'd like.  For this reason, I think it would be helpful to have a link available to provide folks with a pre-written answer.  

It's not that I don't ABSOLUTELY LOVE interacting with my readers (I DO!!!  Feel free to say hello anytime!!), but I feel bad when it takes me a few days to get back to someone who has come to me with a question that is important to them RIGHT NOW.  I remember the days of choosing a pump.  I remember wanting as much information as I could find, reading forum after forum, and just wanting to get the decision made so we could move to the next step.  It took me 15 months before I felt ready to tackle another learning curve...once I crossed that hurdle, I was ready to ROCK-N-ROLL and just wanted to DO IT!!!!!

I should note here that I'm going to share the things that are important **TO ME** when it comes to choosing technology to manage Sugar's diabetes.  You may have a completely different set of preferences.  And that's okay.  Just because I value something you don't, doesn't make either of us wrong.  We each know what our lives entail.  We each know what our individual needs are.  So take this information for what it's worth and delete it from the brain if you decide it's just taking up valuable space...deal?  

By the way, I'm going to be mentioning the top 3 insulin delivery technology options available in the United States.  This doesn't mean they will all be available in your area...nor does it mean there aren't other options out there. 

Oh, and one more thing.  I'm not a doctor.  I'm not a CDE.  I'm a mother doing the best she can to be a pancreas for her daughter.  What works for my child may not work for you or your child.  So don't misconstrue anything you read here as medical advice.  It's just our experience....not advice about how to manage yours.

All of that being said, and without further ado, here are the reasons we've chosen to manage Sugar's T1D using the Animas Ping Insulin Pump.

1)  Insulin On Board (IOB):  (Also known as "Bolus on Board" - BOB) If you've been reading Candy Hearts for awhile, you probably already know the value I place on this feature for Sugar's safety.  IOB (aka "Bolus on Board" {BOB}) keeps track of the unused/active insulin still circulating in the system.  Animas technology keeps track of active insulin for BOTH corrective doses AND insulin given to cover carbs.  This is something I consider essential, because Sugar does not necessarily need to be corrected everyday, but she DOES eat carbs everyday.

The Medtronic MiniMed insulin pump system offers a similar IOB feature.

The Insulet Omnipod offers an IOB feature for corrective boluses, but does not keep track of active insulin for boluses given to cover carbohydrates.

I should point out that, if you're on shots, the IOB is essentially the reason you probably do not correct more often than every 3 hours.  You don't have the IOB information at your fingertips and have learned to manage T1D this far.  Admittedly, IOB is something I've become dependent on.  She eats randomly, more on some days, grazes on others....often I'm checking a blood sugar within a 2 hour window from her last dose -- without IOB, I would NOT correct at those times...in fact, she would probably need to stick to a more regimented eating schedule for her overall management.  Having the security of IOB allows me to calculate a correction, regardless of why or when the previous dose of insulin was given.  Then, based on her current blood sugar, the pump will let me know whether a correction is or is NOT advised.  Being able to correct confidently sooner brings blood sugar spikes back to normal range more efficiently.

HERE is an excellent article about IOB written by Gary Scheiner, a renowned CDE and author of Think Like A Pancreas.

HERE is a brief overview and description of what IOB is from the CWD website.

HERE is another helpful article from DiabetesNet.com. 

HERE is a post from a PWD with the same IOB concerns I have.

HERE is a recent example where the IOB feature of Sugar's pump saved the day....it occurred when Sugar was in the care of a **NEW** babysitter while her dad and I were about 30 minutes away, and clearly demonstrates why it is important that an insulin pump keep track of active insulin for carb boluses.  It reiterates the reason I feel this type of IOB feature is an essential part of Sugar's overall safety and provides extra peace of mind when she is not in my immediate care -- whether that be at a playdate, church class, school, or just because she's in the other room trying to assert some independence without me standing over her shoulder. 

2)  0.025u Dosage Increments/0 Basal Option:  Let's face it.  A little insulin goes a long way, especially in little people.  Animas allows dosing increments to be programmed 0.025u at a time.  Try as you might, you will never be able to draw that up in a syringe -- even if you're using a syringe with half unit markings.  No matter how you look at it, you'll always be guessing....that's IF you can even get such a minute amount past the needle and into the syringe itself.

Additionally, I have found it necessary to program a ZERO basal from time to time to assist with managing a pattern of lows.  This typically happens overnight, but has also been the case for regular daily physical activity -- for example, she had some post activity lows when she was taking swimming lessons every day for 8 weeks.  I found it useful to keep her basal set at zero for an hour before the swim lessons and it helped.  I suppose a temp basal would do the same thing, but then you'd have to remember to program it every day.

THIS POST demonstrates the power of one little drop of insulin.

The newest Medtronic MiniMed Revel pump also offers 0.025u dosing.  You can also program a zero basal.

The Insulet Omnipod does not offer 0.0.25u dosages.  The smallest unit of dosage available is 0.05u.  Additionally, you CANNOT set a zero basal as part of the regular pattern.

3)   The Remote:  Simply put....I LOVE IT.  The PING remote acts as both a blood sugar meter using One Touch strips and a remote insulin delivery device.  I've bolused through the door while she's in the bathroom (Oh, yes, I have.  Nothing is sacred when you need to get a pre-bolus working and dinner is about to hit the table), from the hallway outside her bedroom, while she's in the backseat of the car, and across the table in restaurants.  I love the remote PERIOD.  It provides detailed information about blood sugar history and averages, including graphs and charts that break everything down according to the section of the day.

I've heard that the Medtronic MiniMed also offers a remote feature, but have never met anyone who is actually using it.  I've never seen it and do not know any specifics about it.

The Insulet Omnipod, uses a wireless PDM for managing all tasks.

4)  Pump Bolus:  Yes, I love the remote.  BUT, I have been stuck without it.  A time or two, it hasn't made the transition from the gym bag to the purse, it's been left on the countertop when loading the fam to the van in a hurry, once we accidentally left it in a doctor's office waiting room an hour from home...whatever....  We're not irresponsible people...but we have been caught without the remote unexpectedly from time to time.  In these moments, I appreciate the ability to administer a bolus from the pump itself.

The Medtronic MiniMed does deliver boluses from the pump.

The Insulet Omnipod only delivers a bolus from the PDM.  A carb/correction bolus cannot be administered if the PDM is not available.  The basal insulin, however, will continue to infuse, regardless of how far away the PDM may be.

5)  Sites:  When we first began our pumping journey in 2007, Sugar wore a different insulin pump that has since stopped manufacturing.  At that time, we were using the infusion sites that came from the same company as the pump.  Well....they didn't work us.  I couldn't get a site to last longer than 36 hours, no matter how meticulous I cared for it.  After a few frustrating weeks, I started shopping around in search of other infusion sets.  We found the Animas Inset (straight insertion) and have never gone back.  I appreciate that there's a small amount of adhesive as, sometimes, Sugar's skin gets irritated and itchy -- I don't like risking infection from skin breakdown and dirty fingernails in precious real estate areas that are used for her infusion sites.  The less adhesive with sturdy application, the better!

The Medtronic MiniMed offers a variety of infusion sets.  However, they use a proprietary system, so you cannot try products from other companies.  The amount of adhesive used is comparable to the Animas Insets.  In fact, the new MiniMed MIO infusion sets are practically identical to the old Animas Insets that we've been using for years.  I don't think this is by coincidence. 

The Insulet Omnipod obviously uses only the pods themselves.  The pods tend to be bulky and use a great deal of adhesive surface area.  Currently, the entire pumping community is awaiting the release of smaller pods...which are expected to reduce in size by about 40%.  Any day now???!!!???!!!

6)  Waterproof:  Sugar has been swimming, tubing on a lake, running through sprinklers, playing at splash parks, and caught in the rain with her pump on.  During the summer months, we usually disconnect the pump and store it in a cooler while at the pool.  I often keep it in a plastic bag and just toss it in with the drinks...there's been a time or two that water has leaked into the bag.  Suffice to say that I was very glad her pump was waterproof!  

(**NOTE**  The remote is NOT waterproof)

Looking back, I'm not sure that allowing the pump into the lake was the smartest idea, and I'm thinking we probably won't do it again.  If that sucker had fallen off....I shudder to think.....  It's probably a better idea to take it off before next summer's run on the tube and taking a dive to swim with the fish.  Even still, at the time her life jacket was covering the pump pack and....well....we were all just so excited to be out in the boat that we forgot about it.  You heard that correctly.  WE FORGOT ABOUT THE PUMP!!!!!  Oh well.  Hindsight is 20/20....all's well that ends well!!!!!

The Medtronic MiniMed is NOT waterproof.

The Insulet Omnipod is waterproof, but the PDM is NOT waterproof.


I guess those are the big reasons....there are other features that we like too -- combo boluses, temp basals, and other stuff like that -- but all of the pumps have these features, so it's really nothing that sets Animas apart.  While I'm on the topic of technology options, I'll answer a few other questions too...


WHAT ABOUT CGM?  Well, during our pumping days previous to Animas, we tried it.  Honestly, we didn't like it.  It was cumbersome to have 2 sites and I felt like it wasn't accurate enough to be worth the extra time, effort, and test strips.  I didn't know how to process all the extra data and couldn't bring myself to trust the dag-on thing.  That being said, there are LOTS of DOC bloggers who LOVE their CGM's.  I'm probably not the best person to talk to about CGM...sorry.  SEE THE UPDATE BELOW!

Medtronic MiniMed has a combined insulin/CGM pump -- there are still 2 sites, but only one device.

Both Animas and Insulet have contracts with Dexcom and combined pumps for both of these companies are expected soon.  Well, you know....as SOON as SOON gets with this stuff.

***UPDATE 2/11***   Since writing this post, we have started using the Dexcom continuous glucose monitor.  Most of the time we like it.  Sometimes we don't.  HERE is a review from our trial week, and HERE is a more comprehensive review after using it for 2 months.

WHAT ABOUT THE TUBING?  Well....what about it?  I suppose there have been times when the tubing is inconvenient, but it's really not in the way -- EVER.  No more inconvenient than placing a bulky pod on a diaper wearing baby, keeping it from wobbling on a small arm, or accommodating it under a tight shirt.  We can either be concerned with tubing that hardly ever causes an issue or worry about a pod getting bumped, deactivating, and having to waste excess insulin (which appears to be a pretty common issue that people get frustrated by...I could list example, after example, after another, and still more examples or 6 pages worth about the frustrating rate of pod failures, but I think you get the point.)  Pick your poison, ya know?  Now that we use the remote, Sugar can wear dresses without worrying about needing to access the pump (this was probably our biggest tubing inconvenience), and we've found some great pump packs that do a good job of keeping the tubing securely hidden.  The tubing is simply a non-issue.  It always has been.  When we first began pumping in 2007, the tubeless Omnipod wasn't even an option.  It was TUBING OR BUST, BABY!  We've never looked back.

WHAT ABOUT SITE PROBLEMS?  Honestly....they hardly ever happen for us.  Site dilemmas are part of the journey.  Not gonna lie.  Don't want to sugarcoat it.  You WILL have a site issue or 2 if you're a pumper/podder.  It's just reality.

HOW DO I GET READY FOR THE PUMP?  There are a few books that I've found quite helpful.  They both contain WAY more information than what you need in the beginning, but the intro to pumping sections are good reads, and it's nice to have a reference handy as you become more comfortable.

Think Like A Pancreas

Smart Pumping

Pumping Insulin

WHAT IF I HAVE MORE QUESTIONS?  Well, JUST ASK!  You can either leave a comment here or drop me an e-mail (candyheartsblog@gmail.com).  I'll get it answered as soon as I can.  If you leave a comment, I will it answer it in a follow up comment, so be sure to check back....and, if you're reading this for the first time, you may want to peruse the comments for more information.

In the meantime, be sure to check out Meri's Pump Parade, where she features a link to users of each pump option I've mentioned here.  The Pump Parade offers additional perspective, photos, and information regarding the 3 most popular insulin delivery technology options.

From My CANDY HEART to Yours,

PS -- Commenters, please leave your name and what pump/CGM you're using so folks can peruse your blogs for more information about other pumping experiences!