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?

It’s Like Riding a Pump

Errr… bike?

Have you ever switched back to your old pump?  For various reasons, well one really (I ran out of supplies waiting for the New Year), I decided to go back to my trusty Medtronic Paradigm 722.

I haven’t worn Gidget since… October of 2013?  And I have to tell you, going back was amazing.  I thought I might have trouble priming.  Figuring out how to insert the infusion set.  Or change the old basal rates to my current ones.  Nope.  I did it all at 6am, groggy with sleep, no coffee.   When I finally got up for the day around 8, Gidget was chugging, or clicking away, and my sugars were around 110.  What, what!?

I thought it would be a roller coaster of trial and error trying to figure out what I did wrong.  Did the insulin make it through the tubing?  Did I bend the cannula?  Is my carb ratio still the same?  After years of being turned off will all of the settings still be in there?  All was there, all worked out in my favor.  Neither one of us forgot.  It was like riding a bike.

So fret not my fellow pumpers.  The day when you need a backup pump that you haven’t used in years, it will be waiting for you, ready to jump into action.

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. 

Oppe for the Win!

Lately I’ve been having a few lows before I go to bed.  Right when I get comfy under the covers my Dexcom goes off.  Not the best timing but better than in the middle of the night.  Any who, I keep a Carpi Sun on my nightstand so hopefully I don’t have to get out of bed.  What… I’m lazy, it’s winter and I’m all snuggled up.

Since I’ve had so many of these bedtime lows I’ve gotten really good at throwing away the juice pouch without even looking for my tiny trash can.

I would have to say 4 out of 5 times after I gulp down the fake juice I throw the foily pouch over my shoulder and hear it land with delight (no swish) into my plastic bin.  I look over and there it is sitting on top.  Not too bad!

I’m pretty sure I’m the Larry Bird-of Capri Sun-nothing but net- three pointers in my trashcan-diabetic champ.  At least in my house.

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: Night of the Living Low

lowLast night I woke up to find I was severely low.  So low it just said LOW.  Yeah, one of “those” lows.  So I went to the kitchen and gulped down my 8 sips of orange juice.  Usually that picks me up and I’m good to go.  Apparently not last night.  As you can see I was low pretty much from about 1am until 7am with a teeny tiny peak around 4am of 80. So I kept eating.  Like a never ending circle, I kept eating.  Crasins were my go to snack.  I brought my Costco size bag to my bedroom, got back under the covers (it’s -2 here in Denver so there was no way I was staying in the cold longer than I had to) and I started watching Netflix to keep myself awake.  I ate handful after handful and watched four full episodes of Hart of Dixie. (I don’t know why I chose that show in my low induced fog but I did).  I was awake for easily four hours last night, shivering, low, eating an insane number of calories and carbs, and pissed off.

I don’t know how many carbs I ate.  I don’t know why I was low for such a long time.  But I do know I didn’t get enough sleep so before I go to bed tonight I am eating a peanut butter sandwich with a  glass of milk like I use to back in the good ole days.  That was my bedtime snack to help me sustain a stable blood sugar while I slept.  Who knows what it really did for me, my NPH middle of the night spike, and no Dexcom back then, but it seemed to work so I’m trying it again.

Political Ads Make Me Go Ugh

***I wrote this about two weeks before Election Day but hesitated to post due to the fact I am a journalist and am suppose to be biased. Now that the election is over I feel more comfortable posting.***

Colorado is known as a purple state. We are much divided. We love our guns. We love our pot. We love and then hate and then love gay marriage. (Just pass the damn bill and let it be!) And this year’s race for Governor, Senate, and Congress is in full swing…and so are the political ads. I work for a news station so I see ads probably more often than a normal person. And yes they are annoying, usually false, and when they use a statistic about their candidate that is over 4 years old, I dismiss it completely. (Find some new “dirt” or move on!) But there is one ad that is playing a lot and it’s about type one diabetes and stem cell research. What this mother says about diabetes and her daughter really grinds my gears. Watch it here.

The claims this mother makes are ridiculous. While they are technically true, if someone ever said them to me, I would slap them. “Nine times a day she checks her blood sugars to make sure she doesn’t have seizures. “ I know having seizures is something that can happen but aren’t you checking your sugars for more than that one reason? If that was your biggest worry then hell, go ahead and let her sugars run high. Maybe she’ll just go into DKA but hey, it’s not a seizure! And then, “I know a diabetic child has a shorter lifespan.” WHY WOULD YOU SAY THAT! I know it may be true that we don’t live until we’re 95 but that doesn’t mean we won’t have healthy, happy, long lives. It just sounds so terrible when you say that we’ll die young. Like we’re missing out on a wonderful life filled with happiness. I’d hate to have a mother like that and have her tell me I’m going to die before everyone else and that I could fall over and seize at a moment’s notice.

“Who is Mike Coffman to put his personal beliefs ahead of my child’s life?” Who are you to use your daughter’s disease to bully viewers and push your agenda!?

Alright, I’m done.  Just wanted to vent about it.

(These opinions are my own. I am not stating I am for or against Mike Coffman. I just know I am over this bullshit.)