Keep Up the Approvals FDA!

From Dexcom’s Website:

“Dexcom announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.

“The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation.”

About Dexcom G4 Platinum with Share:

• The Share receiver is anticipated to ship to new patients in early March 2015.
• All patients who purchased a Share cradle will receive a free upgrade to the Share receiver.
• All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver.
• There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver.
• The Share receiver will be compatible with future generation Dexcom sensor systems.

About the De Novo Classification Process:

The FDA reviewed the mobile app software used with the Dexcom Share receiver (both the “Share” app on the patient’s phone and the “Follow” app on the caregiver’s phone) through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The FDA has specifically classified the apps which communicate with the Share receiver as a secondary display device and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display. This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring. The Share receiver was still evaluated as a Class III medical device.”

I wonder what that means for Night Scout.  Will I be able to share my info to my phone and then to my Pebble without al the extra cords?

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Do You Feel Like a Machine?

The other day I treated myself to a massage.  They don’t happen often and I never really plan on where my pump and cgm will be placed before going.  This time my cgm was on my upper left thigh and my pump on my right flank?  Something like that.  When I talked to the therapist before we started I mentioned to take note of my cgm and work around it as best as possible.  Then when we got started I also mentioned my infusion site.  She asked if that was my pump, then what was on my leg.  Explaining the devices and what they did she said, “Oh, do you feel like a machine?”

Yes.  Yes I do.  That, or a robot.  Or a Cylon.  Hence my blog title.  But it’s a wonder why people ask questions like that in the first place.  When they see someone in a wheelchair do they ask, “Do you feel like a car?”  Or someone with a prosthetic leg, “Do you feel like a pirate?”  But more than anything, shouldn’t I feel like a human?  I’m not bothered by people who take interest, ask questions, and want to better themselves and learn more, but you can do that without asking questions like, “Do you feel like a machine?”

On a side note though, just a few days ago I posted a Tweet about my pump.  “Some days I am amazed I live off of a machine.”

And I am.  I find it incredible that I’m attached to a fairly small piece of equipment that can deliver tiny amounts of insulin and keep me alive.  I know shots can do the same thing but technically, if I didn’t eat (and everything went my way), this machine wouldn’t need me to do anything for at least three days.  Sometimes it hits me how far we’ve come since diabetes was labeled? Discovered?  Named?  And I am in awe of how I am able to live a “normal” life,

So while I don’t want to feel like a machine all the time, or have people point it out to me (especially when I’m trying to relax,) I am part machine. And doggone-it, people like me. 

No Mood

I am really in no mood today to post because work is being a big ole bitch.  And tomorrow is not going to be any better.  But what really tops the sundae is no frickin’ cherry.  It’s my Dexcom continuously going off with false lows.  Just slight ones.  I’m at 82 and it’s beeping at me saying I’m 69.  I’M NOT!  Just stop!  So I SHUT IT DOWN!  Literally.  Shutdown has happened.  I’ll turn it back on when I get home but right now at work, I can’t handle it.  I can’t handle anything!  Blerg.

Wordless Wednesday: Now That’s Better

After yesterday’s whiny post about basal rates I made a few tweaks and things are finally looking more normal.  Still started to go up later in the morning so I tweaked that and hopefully tomorrow I’ll have even better results.

3

 

Basal Rates

I understand changing your rates.  There are times when you do so more often.  You’re pregnant, on a new medication, exercise regiment is different.  What I don’t get is why all of a sudden I’m high around 2 am, then dropping to about 55 at 6am and then spiking back up into the 200’s by 10am.  And that’s without eating or taking any insulin.

Did my hormones all of a sudden go completely out of whack?  Is my body rebelling against me even more?  What the h-e-double hockey sticks is going on!?

It is beyond frustrating.  I’ve been doing everything you can to stay in control, especially overnight.  All I want is more than 4 hours of uninterrupted sleep without Roxy yelling at me. First it’s just a peep saying, “I’m high.”  Then it moves on to, “Pay Attention to Me!”  Then finally, “I SAID LOOK AT ME!”

This happened to me a few months ago and I can’t figure out if this is a similar situation or if some new factor has reared its ugly head.  So after three nights of being pissed off I am changing my basal rates Again and hopefully I’ll have some success.

I imagine a Dexcom is kind of like having a baby.  But when a real baby wails you can’t throw it across the room, hide it under your pillow, or ignore until you’re finally back in range.

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Nightmare on Elm Street

Or in my case… Marion Street

I’m sure most people know the premise of Nightmare on Elm Street.  A bunch of teenagers (including Johnny Depp making his big screen debut) are stalked and killed in their dreams (and thus killed in reality) by a severely burned man named Freddy Krueger.  So to avoid being murdered in their sleep they stay awake for days.  They drink pots of coffee, take caffeine pills, listen to blaring music.

Last night I woke up around 4am to a blaring Dexcom saying I was low…and man did I feel crappy.  My tongue was numb, I was sweaty, vision was blurry.  I popped the straw into my nightstand Capri Sun and gulped it down.  Then I waited for the sugar to kick in.  But waiting for your sugar to come, especially in the middle of the night when you are beyond tired, is ridiculously difficult.  I just want to close my eyes and hope I drank enough carbs that will get me through to the morning.  So I went to Facebook, I put on music, and I played a game of Candy Crush waiting until I felt better.  I noticed another D-pal was on Facebook after dealing with her second low of the night.  Her post: “The calories I consumed during my two (yes two) low blood sugars’ refrigerator binges (so far) don’t count. Right? I said right?! (I’m looking at you Halloween)”

That got me thinking. How many of us are there up in the middle of the night at the same time, and what do we all do to pass the time until we feel better?  Granted there are times where I am literally sitting on my kitchen floor, eating straight out of the fridge and the only thing I can do is eat till I feel better.   Then I bolus.  (Don’t judge, we’ve all done it.)

What do you do to stay awake?  Wake up your partner until you feel better?  Walk the halls until you’re not tingly anymore?  Stare at your meter and Dexcom until you see the arrow pointing up to safety? Hopefully no one is taking such drastic measures as the kids living on Elm Street but whatever it takes, right?  They’re trying to survive Freddy, we’re trying to survive a low blood sugar.  It’s all relative… kinda.

Oh and maybe it’s just me but after a middle of the night low, waking up the next morning is almost impossible.  I usually sleep through my alarm, wake up late and then drag ass half the day.  Ugh.

And for your viewing pleasure, Johnny Depp in a belly football shirt.

HAPPY HALLOWEEN!

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In the Middle of the Night…

About a week ago I had a bad low while sleeping  As I sat on my kitchen floor drinking Capri Suns and eating Crasins with my dog looking for a hand out, I started singing “In the Middle of the Night” by Billy Joel.  Then I started laughing like a madman because I thought of the line, “in the middle of the night, I go low in my sleep”.  I thought it was hilarious, though it very well could have been a side effect of the low.  But that song has stuck with me so I decided to change the words of the one and only Billy Joel, and make it into a D-Song.  So if you play Mr.Joel’s music video and sing the words below, I found it very catchy.  And now I sing it all of the time.  I may have too much time on my hands.  Oh well.  Enjoy. (and fyi Roxy is my CGM’s name)

In the middle of the night
I hear Dexcom go beep
From the mountain of pillows
To my dreams so deep
I must be feelin’ something
Something sweaty and shaky
But the sugars too low
And it’s too hard to move

Even though I know that the kitchen is there
I walk down every hall and I stop and stare
I try to fumble with the light switch off
So I can finally find what I’ve been looking for…

In the middle of the night
I go low in my sleep
Through the panic and fear
I hear Roxy go beep.

I’ve been searching for something
Taken out of my blood
Something I’d like to eat
Something to keep me in control

I don’t know why I go low at night
But now I’m tired and I don’t want to eat anymore

I hope it doesn’t take the rest of my life
Until my blood sugar stops dropping down no more

In the middle of the night
I go eating in my sleep
Through the pantry of food
To the freezer so deep
I know I’m searching for something
Something sugary sweet
That I can shove in my mouth
Hopefully a delicious treat…

In the middle of the night

I’m not sure how many carbs are in this
God knows I try to stay between the lines
I fantasize that I’m perfect as I eat
Hoping that it’s only fifteen or twenty grams..

In the middle of the night
I go up and down in my sleep
Through the sugary maze
And the trials of the “D”
We’re all looking for balance
We all want that safety
That our CGM brings
To the sleeping d-peep
In the middle of the night

Now if only Billy Joel would record it with these words… That’s tomorrow’s project!

Ill-placed CGM

I wanted to give my legs a little breather from CGM and pump action.  It was starting to look like I had a case of the chicken pox solely on my thighs.  So this afternoon after taking a 3-day break from my Dexcom I decided to place it at belly button line on the right side of my stomach.  After attaching the transmitter I regretted placing it there instantly.  It looks like I have a rounded rectangular shaped growth.  Maybe it’s just the dress I am wearing but I try to hide my chubby waist line… not emphasize it.  I’m hoping tomorrow’s outfit fairs better for me but for now, I’ll just tie a sweatshirt around my waist and call it a day (and pretend it is 1996 when it was fashionable to wear sweatshirts around waists.)

Prepare for the worst

3… 2… 1…

Kittens, kittens, kittens.

Hold your breath.

What do you do before you squeeze the buttons allowing your pump infusion set to inject itself into your body?  Or feel the sting of the needle being pushed into your thigh when replacing your cgm sensor?  Or back in the good ol’ days I would use my BD Inject-Ease automatic injector and carefully load my syringe before plunging it into my stomach.

When I first made my way into the CGM world I tried out Medtronic and that one HARPOONS you.  I use to count to three and then pull it away.  It would take me easily two to three times before I finally “pulled the trigger”.  (http://www.youtube.com/watch?v=ReZX7rLi5D8   Watch at two minutes in and you’ll see some major harpooning.)

I now use a Dexcom g4 and it works like a charm.  Love it.  Sometimes there is a little pain but this morning as I pushed the needle into my upper thigh I was pleasantly surprised.  Didn’t sting.  Didn’t bleed.  Didn’t anything.  I didn’t feel a darn thing.  I taped it up, started the sensor, and was on my way.

Some days you prepare for the worst… out of habit, out of fear, out of previous experiences.  But when things go smoothly… do a little dance of victory.

 

Wordless Wednesday: 24 Hours

I’ll take that graph for 24 hour of diabetes!