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Urgency – #Vote4DM and #DOCasksFDA.

Today is the last day to participate in the #DOCasksFDA survey.  The link is HERE and you can just CLICK ON THIS LINK and I’ll stop using the caps lock key.

Also, if you’d like to contribute your voice and share your dream for the future of diabetes, do it.  Do it via video, if you’re so inclined, like so many others have done.

Also, the Strip Safely team is bringing about a new advocacy initiative, using Twitter to target our legislators.  As the campaign tagline says, “We voted them into office.  Tell them to #Vote4DM.”  There are three diabetes bills that are currently in play up on Capitol Hill, and by visiting the Twitter page for Strip Safely, you’ll see some customized messaging all ready to go for your specific representatives.  For more information on the bills on tap and how you can raise your voice, CLICK HERE (damn it – that all caps button is my best friend these days).

Thank you, as always, for being such a crucial part of the diabetes community.  This whole thing would fall flat without you.  (SERIOUSLY.)

What Does the DOC Mean to You?

Two weeks ago, the #dsma chat was centered on the how and why of people’s participation in the Diabetes Online Community (DOC), and after chat participants shared what brought them to the web for diabetes information, the last question of the night asked them what the DOC means to them.

The answers created a quilt of community and comfort that can’t be denied:

And for me?

Tune in to tonight’s #dsma chat at 9 pm EST. For information on how to get started with Twitter, jump back to this Diabetes and Twitter 101 post.

Twenty-Eight and Thirteen.

Twenty-eight years ago, I was diagnosed with type 1 diabetes. It’s a moment in time that is so jumbled up with other things – my grandfather had been in a horrible car accident a few months prior to my diagnosis, my older cousin died in a car accident just after my diagnosis – there are memories of people in my family crying and there were so many reasons.  Vague memories of being in Rhode Island Hospital for two weeks, the kid with the spider bite, and practicing injections on an orange serve as markers on the timeline of my diagnosis, but clear memories don’t exist.

Diabetes has always been there.  It doesn’t get easier with time, but it does become more routine and less mentally intrusive.  Either that, or I’ve just become used to the intrusion.

I remember September 11, 2001 very clearly.  I was working in a bank in Newport, RI right near the naval base.  It was my first job after college, and the first plane hit the WTC as I was driving over the Newport Bridge to work.  My coworkers told me about the first plane when I arrived at the bank.  The security guard at the bank told us when the second plane hit.  I remember calling my father because I didn’t know what else to do, and he told me it was going to be okay.  His voice was calm.  Despite his inability to actually influence the events that were unfolding across the country, his words were reassuring and made me feel safe.

I feel very lucky that I didn’t experience personal loss on that day.  My heart goes out to those who did.

The nation is in mourning and I mourn with my country.  Simultaneously, I mark the anniversary of my diabetes diagnosis. I always think about people whose birthdays are on September 11th, or whose wedding anniversaries are September 11th.  I think about the people who lost so much on September 11, 2001. It’s a day where I feel conflicted thinking about diabetes, but it’s impossible not to apply personal bias to life.

I think it’s a day to close the damn computer.  To not read every news article and overwhelmingly sad bit of news being shared.  It feels like a day to be present, to remember to live.

 

Help People with Diabetes Access Care Data; Medicare CGM Coverage.

There are advocacy tides rising this morning, and we have a chance to jump on board.  There are two opportunities to raise our voices.

The FDA has proposed new guidance for  Medical Device Data Systems (MDDS) and the diabetes community has the opportunity to comment on that guidance document.  There are more details on the StripSafely website as to what that means and why we should care.  We have until August 25th to leave our feedback.

Here’s what you can do:

Leave Your Comment on the FDA Draft Guidance.

1.  Highlight and copy the text in red below:

Support:
I am encouraged by the FDA’s draft guidance on MDDS. I support the FDA’s position that technologies that transport data, without changing values, are low risk. I believe that access to medical data should be available on multiple platforms that are accessible to both medical professionals and patients. Access to this type of data is becoming increasingly essential in healthcare, with the potential to reduce costs and improve outcomes – in fact, not having timely access to needed data poses a far greater risk. I strongly support access to this type of data and am pleased to see FDA recognizing its importance.

Diabetes:
People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning. I am happy to see that in his blog post Bakul Patel specifically mentions diabetes devices. I support this guidance’s decision to not mandate the PMA process for MDDS that include diabetes information.

Suggestions:
The draft guidance seems to be focused on data provided by MDDS to healthcare professionals. It should be modified to also explicitly state the value of access by patients, particularly for chronic conditions like diabetes where patients need access to their own data to manage their own care as safely as possible.

Real Time:
The draft in section V-B seems to precludes active patient monitoring. Specifically how or if this impacts diabetes is unclear. A clear definition of active monitoring should be included in the guidance. I strongly suggest that real-time access by patients to their own data *not* be defined as active patient monitoring. I strongly support including in this guidance more open access to information from continuous blood glucose monitoring for patients with diabetes. The appropriate risk of device performance is regulated through the device PMA, and shifting CGM data to secondary screens does not in any way increase risk. From a patient perspective, secondary screens significantly decrease risk by making information more readily accessible to the patient. This is particularly relevant for those of us who may be unaware of early stages of hypoglycemia.

ER and Hospitalizations:
Geller et al estimate in JAMA (JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136.) that almost one hundred thousand Americans a year are treated in the Emergency Room for insulin related hypoglycemia and that about one third of those are admitted. Timely access to real time sensing data may help prevent many of these ER visits. This suggest real opportunity to mitigate risk through secondary device display of CGM information.

Multiple Data Sources:
Existing regulations state that ‘Accessories to classified devices take on the same classification as the “parent” device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the “parent” device with the highest risk, i.e., class.’ (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm ) People managing diabetes often use multiple devices to provide the data needed to follow care instructions. Bringing that data into a single application would improve patient understanding. For example finger stick measured blood sugar, CGM trends, amount of insulin infused, and the time of each are all information that patients juggle. A dashboard displaying all relevant diabetes data would improve safety and reduce risk, compared to forcing the patient to consult multiple devices and displays.

FDA’s Dr. Courtney Lias offered promising comments on diabetes and mobile devices at the Keystone 2014, “Practical Ways to Achieve Targets in Diabetes Care” sessions. Closer Look reports that Dr Lias, in comments on artificial pancreas, spoke of a strong FDA interest in consolidating devices through mobile technology to facilitate better diabetes care. She reportedly spoke of “component artificial pancreas system,” where patients could choose component devices of a system. I fully support the vision Dr Lias shared. This proposed MDDS guidance can encourage logical, safe and incremental steps towards that future by opening multiple diabetes devices to display on a mobile devices.

Conclusion:
Diabetes patients implement the individualized care programs created by our doctors based on real-time data from multiple FDA-approved medical devices. Easing the accessibility of data from those devices improves our ability to follow our care team’s instructions. I support the FDA’s adoption of MDDS guidance that incorporates a nuanced appreciation of the low risk and incredible value in using MDDS to transmit and display diabetes data.

2.  Click here  and paste the text you copied into the comment box.
3.  Fill out your information.  (Note:  You’re commenting as an individual so be sure to uncheck the box that says: “I am submitting on behalf of a third party.”)
4.  Click the Category “Individual Consumer.”
5.  Click continue.
6.  Review, check the confirmation box, and submit your comments.

Sign the “Tell Medicare to Cover Continuous Glucose Monitors for People with Diabetes” petition from the JDRF. 

People with diabetes live longer, healthier lives these days.  (Celebrate!)  As a result, so many of us have the privilege of aging well.  Bottom line?  We’re getting older.  And when we enter the Medicare age bracket, continuous glucose monitors will not be covered by our insurance.  But we have a chance to change things.  Here’s something you can do in less than 1 minute that will make a difference:

  1. Click here for the petition.
  2. Sign it.
  3. Share it.
  4. Pat yourself on the back and carry on.

Oh, this is a real thing with an actual patent pending. (source)

Thank you for giving these issues your attention.  The community is lucky to have you.  And you.  But especially you.

 

Gone Offline!

After too much time away from my family, I need to keep this laptop lid slammed shut for a few days.  See you next week!

Looking Back: Dining Out.

I love going out on the town for the night
And having a meal by a soft candlelight
(Because I know, at a restaurant, meals are yummy;
For the food isn’t prepped, touched, or cooked by me.)
But to dine with type 1 can be quite complex,
Because restaurant food has a whole set of specs
That require some SWAG’ing; carbs seem to inflate
As you wonder what’s really down there on your plate.

“Excuse me, but does the salmon have a glaze?
Is it covered in sugary, caramelized haze?”
I ask of the waiter, tuning in as he states
That the glaze can be brought on the side of my plate.
My soda arrives, and I ask, “Is this diet?”
As I bring the glass up to my lips just to try it.
“It is,” he responds, and he watches my face
As I try to assess the fizzy soda’s taste.

Moments later, I notice that something is wrong.
I’m not sure my thoughts are where they belong.
My brain is all foggy, my hands feel so weak,
I’m having some trouble with words while I speak.
Did I bolus too early?  Did I miscount the carbs?
Is it something I did to make Dex go on guard?
There are glucose tabs right here in my purse,
But I know that I’ll feel better if I have juice first.

My husband is almost up, quick as a blink
To go to the bar to grab something to drink.
But it’s not a big deal; I chomp tabs while I wait
For the waiter to come back and fill up our plates.
He comes back for our order, but I’m not quite ready.
My Dex shows my numbers as slightly unsteady,
With double-down arrows beaming; so unkind.
“Can I have an orange juice, if you don’t mind?”

I see his confusion. The gears start to grind.
I hear the thoughts churning inside of his mind.
“She didn’t want glaze, and her soda was diet.
The bread was right here, but she didn’t try it.
What’s up with this girl? Selective sweet tooth?
Whatever. My job is to bring her the juice.”
He walks off to the bar to bring back something sweeter
While I quickly confirm the Dex trend with my meter.

“Here you go,” and I down it in one giant gulp,
Not caring for class, or a straw, or the pulp.
“Thank you so very much,” I reply with a smile
And try to regain some semblance of my mind.
My husband distracts me with soft, gentle chatter
While the orange juice fixes the thing that’s the matter.
And the moments that pass are quick in real life
But it’s hard for him, watching a low change his wife.

A few minutes later, things are as they were.
I’m no longer sounding all drunk, with a slur.
The waiter comes back with his menu pad out
And we tell him the entrees we’d like to try out.
Our date night moves forward without any trouble.
(The waiter’s confused, but i don’t burst his bubble.)
It’s not a big deal; it was just a quick thing.
But it’s always a riddle, what diabetes will bring.

(This poem was originally published back in January 2012.  It’s from the past.  And I am in Canada, where the poutine lives.)

Diabetes at the Beach.

Rhode Island has some really nice beaches, and since I was a little kid, going to the beach has been a staple of summer.  (If September doesn’t roll around and your car isn’t lined with beach sand, something went wrong.)

Just after my diagnosis, going to the beach didn’t look or feel any different as far as my body was concerned, because I didn’t use an insulin pump or wear a continuous glucose monitor when I was seven.  The only evidence of diabetes was found in my mother’s beach bag, where my meter was stashed, and in the beach cooler, which grew significantly after my diagnosis (bring all the food and all that meme-ish tomfoolery).

Today, my diabetes management looks different.  There’s physical evidence of diabetes right there on my hip, where my insulin pump is clipped, and against my skin, where the CGM sensor is placed.  Hiding diabetes at the beach has become increasingly more challenging, but I’ve also become increasingly more comfortable with having it “out there.”

This week, I brought Birdy to the beach to officially kick off our summer (I’m ignoring the fact that it’s 50 degrees and raining today) and since it was early in the season and a little chilly, I decided for a one-piece tank suit instead of a tankini or bikini.  Usually, I wear something two-piece, and not because I am a big fan of baring it all;  I like two-pieces more because there is somewhere to conveniently clip my insulin pump. But once I put on the one-piece bathing suit, I was struck by the lack of clippy real estate.

Where the HELL do you put the thing? Normally, I clip it to the bottom half of my bathing suit, just like with regular clothes, but this one-piece business made things more complicated. I could clip it upsidedown to the leg opening, but then it would hang there like a Christmas ornament. I could clip it disco-boobs style, but then it’s like HEY INSULIN PUMP the whole time at the beach.

After much frustration and simultaneous thankfulness for long tubing, I decided to run the tubing along my back, inside of the bathing suit (the infusion set was in the top of my left hip) and clip the pump itself to the back of my suit. It worked because I didn’t sit much (thanks, Birdy), so a bulge clipped on the back of my suit didn’t cause any discomfort.

Pump clipped to the back of my bathing suit, Dexcom sensor taped happily to my thigh, and busting out my glucose meter every so often?  Basically, it was diabetes balls-out on the beach that afternoon.

 

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