by Christel -

Two Minute Diabetes Advocacy: #Vote4DM

If you have two minutes, you can make a difference for people with diabetes (even if YOU don’t have it). Got a Twitter handle? Have we got a deal for you…708615_95129272

It’s an exciting time of year! It’s football voting season. Congress seats will be up for grabs and we want to remind those currently in power that they can’t forget the millions of people with diabetes and their friends vote. And we want them to know what’s important.

You want your voice heard in Congress?

Then tell them to #Vote4DM.

There are three bills that are currently in play up on Capitol Hill:

S539/HR1074 – National Diabetes Clinical Care Commission Act

Did you know that there are 37 federal agencies that play some role in the prevention and treatment of diabetes?  (Have you ever worked with 37 people in one group? Try 37 agencies!!!) These agencies aren’t always working together, resulting in miscommunication (or lack of communication), reinventing the wheel, and wasting of resources.

The National Diabetes Clinical Care Commission Act will coordinate diabetes efforts. The Commission will include federal agency representatives, patients and health care providers, and will use existing funds at no extra cost to taxpayers to do its work.

S945/HR1274 – Access to Quality Diabetes Education Acts

This bill will increase access to diabetes self-management training (DSMT) by designating credentialed diabetes educators as certified providers for purposes of outpatient DSMT services under Medicare Part B. It’s “budget neutral“, meaning that the cost of the outpatient services will be offset by the savings provided with the program.

 S. 2689/HR5644 – Medicare CGM Access Act of 2014

Medicare does not currently cover CGM devices, leaving people over 65 with type 1 diabetes (T1D) without coverage for continuous glucose monitors. Did you know that right now, costs for a hypoglycemia inpatient admission average $17,564 per visit!?

Passage of the bill will facilitate Medicare coverage of CGMs, and help pave the way for the next generation of CGM-related technologies, such as artificial pancreas (AP) systems.

unnamed-3Here’s what you can do.

Participate in the two Tweet-Ins for #Vote4DM: a 24 hour Tweet-In beginning on 10/22 (Wednesday) at 8pm EST and then another 24 hour Tweet-In beginning on 10/29 at 8pm EST. (If you can’t make these times, you can still tweet these messages out. It’s just important that you tweet them!)

StripSafely‘s made it so incredibly easy for you to use the power of Twitter for good.

Let’s get a 100% #VOTE4DM from our Congressional representatives and vote diabetes out of office.

1. Find your representative in Congress easily by clicking on this link and entering your zip code. (Remember that name or keep that page open for your reference.)

2. Go to the StripSafely Twitter page and let the blitz begin. (Look! A football reference!)

  • You will send three Tweets per person on the list: One for each of the bills currently on the Hill.
  • We are either asking them to cosponsor the bill or thanking them for cosponsoring the bill.

Now:

  •  Tweet the Senate and House leadership and the Diabetes Caucus leadership, regardless of what state you live in.
  •  Tweet your state senator(s) and district representative. 

3. Share the StripSafely Twitter page with anyone who has diabetes or cares about someone with diabetes. (That means share with everyone you know.) Ask them to tweet. 

And that’s it. Mark the date and time in your calendar and help us raise awareness for these non-partisan bills that will help people with diabetes. Share this info with people via Facebook, Twitter, and emails. We would love to shake the Twitter tree and get Congress to see that we won’t be quiet anymore about keeping us safe!

 

by Christel -

Two Minute Diabetes Advocacy: MDDS

Tick-tock, y’all. 708615_95129272

This is a last minute push to get comments on the FDA docket currently out for medical devices. You have until 11:59pm ET Monday, August 25th to get this done.

Two minutes. That’s all it takes.

What is MDDS?

Medical Device Data Systems.

These are systems that, in the FDA’s words, facilitate

“the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.”

 

Think about your Dexcom information on an iPhone or a tablet or a computer or a smart watch. Think about seeing boluses in real time. Think about being able to view medical data NOT on the device itself. For parents of kids with diabetes… kid is at school and mom or dad can see BGs in real time.

FDA thinks that this type of technology doesn’t introduce much additional risk, so they want to lessen the regulatory process (i.e. red tape) for these devices.

We totally agree. 

However, FDA isn’t clear on the topic of “active patient monitoring”, so our goal is to encourage the FDA to

  • Specifically address the importance of giving patients access to their own health data on multiple devices/screens (the more access the better), and…
  • Clarify whether CGM-related technologies will be included in the MDDS relaxed regulatory process. (We believe they should be.)

If you want to read up on this, you can get it from the source (FDA) and you can get additional information over at Strip Safely.

This is what you can do RIGHT NOW:

1. Copy the information below. 

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.

People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning.

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 copied comment into the comment box. Wanna get fancy? You can add why this is important to you. There’s a 5,000 character limit, so you’ll need to delete some of the copied comment, but they’ll get your gist.

3. Then do this. 

  • Fill out your information. You’re commenting as an individual so UNCHECK the box that says:
  • “I am submitting on behalf of a third party”
  • Click the Category, “Individual Consumer”
  • Click continue.
  • Review, check the confirmation box
  • Submit your comments. You even get a receipt to confirm your comments were posted.

4. Do a little dance and high five yourself. You just raised your voice for diabetes advocacy. You rock. 

 

 

by Christel -

Procrastinators Unite… Tomorrow!

1267744_87396573You still have time, you procrastinator you.

The docket that FDA has open on blood glucose test strips has been extended to May 7th. You can use the “Ain’t Got No Time For That” method that I came up with for all of us to comment and kick the number over the 400 comment goalpost. (Or more than 400? Be still, my beating heart.)

Even if you have commented, no one is telling us that you can’t comment more than once, so please bring your thoughts about generic/third party test strips.

Third party test strips are not made by the monitor manufacturer, so who’s responsible if there’s a need for adverse event reporting? Who do we call to report it?  Until there’s a clear cut ruling on this, it’s a Wild West sort of world.

Want to learn more about third party test strips and inspiration for your comment? Head on over to Stripsafely.com and read up. (There’s also a great article on this very topic and details about the companies offering generic strips at Diabetes Mine. A definite must read.)

I know that you’re not a procrastinator, but I’m sure that you know someone who might be. Can you do the 26 million people with diabetes a favor today and reach out to someone in your community (with diabetes or not) and ask them to do you a solid?

Diabetes doesn’t procrastinate. We shouldn’t either…

 

by Christel -

Warning Label

mr-yuk-300x300It’s no secret how I feel about blood glucose meter accuracy: without it, I’m dead.

Blood sugar monitoring devices have become the linchpin in diabetes care. The number shown on a screen is what determines how much insulin I take, whether or not I eat 15 grams of carbohydrates, and in conjunction with a continuous glucose monitor, whether my blood sugar is going up or down. In the days before home blood glucose testing, it was a total shot in the dark as to whether you were “in range”, because urine testing wasn’t accurate. (Then again, neither was the insulins that were used.)

That’s why I’m a vocal advocate for the StripSafely campaign, bringing awareness of the need to tighten standards and help those who have sway over accuracy and accuracy enforcement of blood glucose testing systems. Since it began this summer, StripSafely has made an impact with the FDA and we are continuing to work with those who want to help ensure we get the accuracy we deserve.

A First For The FDA

When a device manufacturer wishes to bring a blood glucose monitoring system to market, it has to submit paperwork to the FDA showing that it’s met the requirements and standards for the device in question. If it already has a device approved, it’s an easier process with less paperwork, basically showing a comparison to the existing device and highlighting any differences.

A recent approval for a device manufacturer came with something never seen in the diabetes device market: a warning label on every test strip box insert, user manual, and meter box. (I’ve redacted the name of the meter because, you know, bears.)

CAUTION

Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality. The {meter name redacted} is less accurate than most other blood glucose meters sold today. The {meter name redacted} does not provide reliable accuracy readings beyond the following margins of error:

For glucose concentrations < 75 mg/dL, 95% of the results shall be within ± 15 mg/dL.

For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.

DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
And on every test strip box:
The {meter name redacted} is less accurate than most other blood glucose meters sold today.
DO NOT USE THE {meter name redacted} TO CALCULATE INSULIN DOSAGES.
DO NOT USE THE {meter name redacted}TO CALIBRATE CONTINUOUS GLUCOSE MONITORS
*Want to learn more? Visit this post at StripSafely: Thanks, FDA.

Why Would You Use A Less Accurate Meter?

Goodness gracious. So, for any person with diabetes who uses insulin (or may have to use insulin in the future, for those Type 2s currently on meds or on lifestyle modifications), you are cautioned by the FDA not to use this product. Why even bother purchasing it when you have other options? If you know that something is not accurate – and that accuracy does matter, why even bring it to market?

Money. Yeah. The meter and the strips are cheap, but what’s the real cost?

Health. Inaccurate blood glucose reading can result in wrong dosing decisions. It can result in hospitalizations. It can result in death.

I’m obviously not the target market for this meter, but I’m concerned that those who are looking to save on healthcare costs (or those who are under Medicaid or Medicare and are bound by whatever CMS approves), will not have a choice in whether or not they have to use it.

Mr. Yuk

The warning label is my most favorite holiday gift from the FDA so far. (Perhaps I’ll make a suggestion to the FDA that the warning label should have a Mr. Yucky face on it, which stood for poison when I was a kid.) I’m hoping that the manufacturer in question recognizes that this is an opportunity to either fix the accuracy of their product – or cut their losses and not bring it to the U.S. market.

Based on past history, however, the company may well just suck it up and stick the warning labels on their product, all for the sake of making a buck. And to that, I say this:

People with diabetes, we’ve got the FDA and StripSafely on our side.

 

Game on.