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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Leave Your Comment on the FDA Draft Guidance.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I am encouraged by the FDA’s draft guidance on MDDS.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The draft guidance seems to be focused on data provided by MDDS to healthcare professionals.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.

 

Giving Diabetes the Finger: iHealth Winners!

(Technically, the post title should be “what finger do you use for diabetes?” but it doesn’t have the same zing! to it.)

Earlier this week, I posted about the iHealth meter giveaway and asked people to answer the question, “Which finger is your go-to one for blood glucose checks?

Give the middle finger to diabetes HA HA HA HA HA HA jokes are funnyWe only had ten options to choose from, so the answers unfortunately couldn’t get too weird.  (Unless you’re old school and remember testing earlobes.  I learned that at diabetes camp.)  The finger-most-favored, by far, was the ring finger, with the middle finger as a distant second place.  Pinkies had their own fan base, and thumbs were the only fingers that received a “Oh, heavens no!  Never my thumb!” sort of response.  (As a community, we are somewhat ambivalent about our index fingers.  Except maybe to point and say, “Can you grab me those glucose tabs?” or “Yes, I can eat THAT.”)

When I examined my hands, it became clear that I was a ring finger/middle finger frequent tester, like many of you guys.  The middle finger just seems appropriate, you know?

As Hilary so eloquently stated:  “Right hand middle finger. It’s a big *@! to TD1″

The winners of the iHealth glucometer giveaway are Binay, Danielle, and Mark B!  Congrats, you guys.  I’ve sent you an email to coordinate mailing out your stuff.

Thank you for entering!

 

Go Bionic: Ed Damiano, Clara Barton Camp, and How the Bionic Pancreas “Really Works.”

During my visit to Clara Barton Camp yesterday, I heard the same sentiment over and over again from the kids wearing the bionic pancreas:  “It works.”

“It was weird not to touch the buttons when it beeped,” Addy said, an 11 year old camper at Clara Barton Camp who has been living with type 1 diabetes since she was two.  “I’d reach down to look at it or touch it when it beeped but then I’d have to remember not to touch anything.”

“A big change from needing to check every beep and look at the devices all the time, right?  So when did you feel like you were used to wearing it?”  I asked her.

“Yesterday.  Yesterday, it beeped and I didn’t reach down.  I just said, ‘Whatever.’”

“You trusted it?”

“Yes.  I trusted it.  It works.  If you check it, it’s perfect.  My blood sugars are perfect.”

Addy has been wearing the bionic pancreas since Sunday, part of  the Bionic Pancreas study taking place at The Barton Center (and also the Joslin Camp) this summer.  She’s one of thirteen campers at Barton taking part in the study, ages ranging from six to 11 years old, six girls suited up with the bionic pancreas last week and seven this week.  “My blood sugars have been perfect – I haven’t been low at all and I haven’t been high, except for one 203 mg/dL.”

If a week without blood sugar excursions sounds like an impossible dream, take heart.  Take pancreas, too, because this technology actually exists and is currently attached to seven girls in Massachusetts.  And not “seven girls stuck in a hospital bed under strict activity guidelines,” but seven girls who are running amuck at camp, swimming, dancing, singing in the dining hall, and burping at picnic tables outside of the cabins.  The bionic pancreas has been highlighted in the New York Times, NPR, chronicled extensively over at diaTribe, and has also been the subject of a frequently-downloaded-and-rabidly-shared New England Journal of Medicine article.

The system has a few moving parts:  two t:slim insulin pumps with the Bluetooth switched on for communicating with the phone (one filled with insulin and one filled with glucagon), a Dexcom CGM, and an iPhone.  An in-depth look at how the technology works together can be found in the NEJM paper, but the basic gist is that the Dexcom monitors blood sugars and sends that data to the iPhone, which is running an algorithm that doses insulin, glucagon, or refrains from dosing anything at all.  Lows can be corrected by glucagon, highs by insulin.  Meals aren’t carb counted, but instead the algorithm “learns” what a big meal, small meal, or snack is based on minimal input from the PWD.

“It’s beautiful,” I said to Ed Damiano, one of the principal investigators on the project, after seeing some of the blood sugar outcomes from previous studies.

“It’s still a little clunky,” he replied.  “I want to see one device, one infusion set.  But this?  It works.”

Currently, the camp study at Barton has girls on the full bionic pancreas system for five days, and then five days on their own insulin pump, but with the CGM blinded to the user and still uploading to the cloud.  Bionic pancreas campers are required to check their blood sugar at least seven times per day.  Due to camp safety protocols, the study team can’t let low blood sugars “ride” and assume that the bionic pancreas will step in with glucagon in time, so success on some levels isn’t judged by minimal time below 70 mg/dL but instead the reliable metric becomes how many times did the study team need to intervene for a low blood sugar.

This summer, there are a few new features on the bionic pancreas.  One is “microburst glucagon,” which is most useful for when people are disconnecting the system for swimming or similar, in efforts to provide a safety net for low blood sugars while doing that kind of activity.  There is also an option for temporary targets, which allows people to adjust their target thresholds.  “Normally, we aim for 100 mg/dL, but if we can adjust the threshold and show a change in the A1C based on that adjustment, we’re able to titrate A1C levels using the bionic pancreas,” said Ed.

Some challenges still exist with the system.  The bulky devices, for one, are their own challenge, but as the project moves forward, the diabetes community rallies to support current needs.  “Donna from Tallygear came up and made these ‘GO BIONIC!” belts in a matter of 48 hours.” Ed said, smiling.  “We didn’t ask her to do that.  She offered, and we are so grateful because the kids love them.”

The kids sing the praises of this device.  Ally, diagnosed in 2009 at the age of five, wore the bionic pancreas the week before Addy suited up. “It really works. When I saw the video online, I thought it was made up. I thought the girl in the video was lucky, and that her numbers were just perfect that day. And then I wore it [the bionic pancreas] and I was like, ‘Wait … it really does work!’”

Addy chimed in, her bionic pancreas belt visible over her shirt:  “Ally wore this last week and now I’m wearing it.  She said to me, ‘If you don’t want to wear it, can I wear it for you?’”

Ally nodded.  “I did say that.”

“Does the weight of the device bug you?”  I asked Ally.

“No.  It’s a little heavier but I don’t care.  Even with all the pumps on and the phone, I could still do a back-handspring in the grass.”

The study at Barton concludes this week and then moves over to the nearby boys’ camp.  But after this study finishes, there is still work to be done.  The amazing bionic pancreas team has come so far and the 2016 pivotal study is in sight, but needs community support to get there.

This is where the Bionic Challenge comes in.

According to the website call-to-action:  “The Bionic Challenge asks each family to raise $5,000 in 60 days (by September 1, 2014). If each family in attendance here today can turn to their friends and relatives and obtain 50 $100 donations (that means finding only about one donation per day for the next seven weeks), we can resume our development effort in September and keep on schedule for our final pivotal study in 2016. If we cannot resume in September, it could jeopardize our ability to secure a recently announced time-limited $20MM NIH funding opportunity, which is due in about nine months (April 15, 2015) and could support all of the clinical costs of our pivotal study.”

tl;dr:  the project needs the support of the diabetes community because, without it, the goal of a 2016 pivotal study may be delayed. If you can donate, please do. If you can’t, please consider sharing this information with someone who can. The more people who know how to help, the better.

After being promised a “cure in five years” back in 1986, the idea of the bionic pancreas being delayed because of money makes me feel insane. I could understand a delay if the technology wasn’t up to snuff, but to delay due to funding is unreasonable.  I saw kids playing outside yesterday afternoon, running around and laughing and having fun and the burden of diabetes seemed only as heavy as the belt around their waist, which with time and technology becomes smaller and lighter.

“I look at diabetes as management and maintenance,” said Ed, as we sat in the Barton Center bionic pancreas command center, where the study team was hard at work monitoring the campers blood sugars from the cloud.  “The maintenance part is the changing of an infusion set, the changing of a sensor, the checking of blood sugars.  The management part, to me, is the emotional part of diabetes.  The fact that you are so often told that you’re ‘wrong’ because you’re trying to thread the needle.  This device doesn’t take away from the maintenance part because it still requires that you wear something, do something, change something.  But it does make the management part smaller.  So much smaller.”

I don’t know if a biological cure will be seen in my lifetime.  I was diagnosed with type 1 diabetes in 1986 and have been living well, but not without frustration, as a host to this disease for almost 28 years.  My perception of what a “cure” is has changed as I’ve grown older, and my hope for something that takes this disease away fades with time.  But seeing the bionic pancreas at work, around the waists of children not much older than my own, and watching the worries of diabetes lifted from their minds and the minds of their families, I feel renewed hope.  More hope than I’ve felt in a long, long time because this is real.  I held it in my hand.  It filled me back up.

Because it works.

You can follow the progress of the bionic pancreas on the Bionic Pancreas website and “like” their Facebook page for more updates.  Links to articles featuring the bionic pancreas are here , and this video shows you how, and why, the bionic pancreas works:

Giveaway: iHealth Meter (but not a bird).

A few weeks ago, a couple of iHealth glucometers showed up in the mail, courtesy of the marketing team at iHealth Labs.  I have not tried this meter out yet, and I have no clue how it performs against my current glucose meter … but I’m curious.  It’s a teeny little meter and it plugs into the headphone jack on my phone, so it definitely gets points for subtlety and discretion, but since I haven’t bled on the thing yet, I am clueless.

Which is why I’m giving away two iHealth glucometers, so you we can figure this thing out together.  Would you like to try one out?  Enter below by leaving a comment, answering the age-old question of “Which finger is your go-to one for blood glucose checks?”

But there’s a bit of a catch – if you win the iHealth glucometer, I would really appreciate it if you would share your feedback with me, so I can share it with my brain (and also include it in a review post).  Would that be okay with you?  Two winners will receive one iHealth glucometer and a box of 50 test strips.  Again, I have absolutely no idea how this meter performs and FOR CRYING OUT LOUD remember that nothing you read on this blog is medical advice, so be sure to check with your medical team if you have questions or concerns or an itchy rash.  (Especially if you have an itchy rash.)

iHealth glucometer and test strips

(bird added for … just for fun, actually)

The giveaway runs until tomorrow night at 10 pm EST and is for US residents only.  The bird does not come with the giveaway, nor do the scratches on my coffee table.

a Rafflecopter giveaway

Snapshots: Fell Off.

Until next time.

Looking Back: Crabs are Evil.

I’ve always struggled with the right amount of carbs for my day-to-day diabetes management (that sounds so formal, as if I plot this stuff on a spreadsheet, which I do not) and overall, my blood sugar roller coaster is less intense when my carbs are minimal (or deeply imbedded into exercise).  Today, I’m looking back at a post from 2010 about carbs, the perils of spellcheck, and finding what works for you.

*   *   *

Crabs are something that people with diabetes are constantly grappling with.  Are crabs good for us?  Should we be avoiding crabs at all costs?  If we have too many crabs in our diet, will our A1c go up?  What’s the official recommendation for diabetics as it pertains to crabs?  Has anyone ever really tamed the wild crabs?  Is anyone eating crabs, right now, as they read this?

(Note:  Spellcheck is my nemesis right now.  It always, always wants to change “carbs” to “crabs.”  As though I have anything against Sebastian and his little sea friends.  Spellcheck also likes changing “bolusing” to “blousing,” as if wearing a puffy shirt is a verb.  For the record, I have nothing against crabs.  Crabs are fine.  And, in my opinion, carbs are fine, too.  Spellcheck is a bit of a bitch, though.  /digression)  

In all seriousness (sort of), I’ve been told, time and time again, that carbs are evil.  That if I maintain a diet that’s reasonably low-carb, my diabetes will thank me for it.  But I don’t think that carbohydrates are the enemy.  In fact, they’re my best molecular friend when my blood sugar is hanging out in the trenches.  (See also:  Reese’s)

But.

I did notice, as I was gearing up for my wedding and working out more than usual, that my very low carb diet and my consistent exercise regimen made for minimal spikes in my blood sugar.  It wasn’t a perfect system, but subbing in vegetables for mashed potatoes at dinner time made for a post-prandial under 200 mg/dl, which (pre-BSparl), was a solid goal for me.  Granted, I didn’t avoid carbs all the time, but I actively avoided high carb diet choices because I knew both my weight and my A1c would pay the price somehow.  And now, post-BSparl, I’m trying to go back to that lower carb lifestyle, because that helped keep me at a weight I was more comfortable with.  (Not that I’m actively avoiding carbs now, thanks to the epic breastfeeding lows that crop up every few hours, so I’m giving myself a big ol’ bell curve on getting back into shape.)

For me, part of the carbohydrate conundrum is user error.  Pre-Bsparl, I was a bit of a lazy boluser.  I never bolused well in advance of a meal, and my post-prandials (and my overall A1C) definitely paid the price over and over again.  It seems that I need to get my insulin pushed through my system at least 25 minutes before I sit down to eat, not five minutes before.  I learned this lesson (23 years too late, eh?) while I planning for baby, and during the course of the pregnancy, it was definitely the case.  Bolusing well before the meal worked better for me.

To each diabetic their own, I think, when it comes to carbohydrate intake.  Some people are able to manage high piles of carbs without the messy spikes.  Other people, like me, might be clumsy with their insulin.  Or sometimes the decision not to carb has nothing to do with diabetes (as in my case, and in the case of my husband) – we go lower carb for weight management reasons.  But there’s no set magical diabetes diet that cures all that ails ya.  Eating carbs, or not eating carbs, is a personal decision that each individual diabetic needs to figure out for themselves.

In the Sparling house, we tend to avoid the carbs.

And we also arm ourselves against the crabs.  Because seriously, you never know.

Friday Six: But Not On Friday.

SUM stuff from around the Internet:

“The latest in this trend is the meme showing a fat little girl titled ‘Lil Diabeetus snacks’ as a take-off to Little Debbie Snacks.  It’s being bandied about on FaceBook as ‘cute’ and ‘funny’; an appropriate name change.  Is it funny?  I don’t think so.”  Kate weighs in on the Facebook meme.

Tuesday’s #dblogcheck was a community success, and seems to have woken up many of the sleeping bears (if you want to picture blog commenters as sleeping bears, which I do, because that’s adorable).  Check out Chris Snider’s excellet Storify recap of many of the blog posts and be sure to say hello on some new and old blog favorites.

Wendy’s daughter has gone to Clara Barton Camp … and she’s also gone BIONIC.

Athletes inspire kids with diabetes at Friends for Life Conference” is the title of this video, but I’m going to assert that adults are pretty inspired by Charlie and Jay, too.

An eighth grader took She Still Smiles and made it into something really, really cool.  Read about Talia’s project here.

“Her former team dismissed her for having diabetes. Her coach and teammates stood by her and struck out on their own.”  Read more about Rebecca Young here, and consider supporting her!

I sent emails to my representatives.  Now it’s your turn.

The “Fakeabetes” Challenge – pretending to be a PWD for the day!  Read more from Kim and Whitney on this day with diabetes.

This post from Meri is a call-to-arms, and I’m ready.  “The Movement Has Begun.”

JDRF appoints Derek Rapp as new President & CEO – here’s more information on this change in leadership from the mothership itself, and a post about the changing leadership of ADA and JDRF on Diabetes Mine.

Why Should Diabetes Advocates Enter This Food Fight?”  Hope Warshaw explains.

“ADA and others have sent in their comments, but the FDA needs to hear our individual voices as advocates.”  You can give the FDA your thoughts on the proposed Nutrition Fact Label, and you have until August 1st to do so.  More on the how, and why, at Diabetes Advocates.

The FDA will host an online conversation (“A Virtual Town Hall”) for people with diabetes on November 3.  And, according to the crew at diaTribe, they want to hear from you!  Click this link for more information and the link to email diaTribe, and you can also join the conversation on Twitter using the #DOCasksFDA hashtag.

My favorite part of this video?  “I can read.”  Love, love, love.

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