Being an e-patient is one thing. Being an actual patient is another.
My finger is detriggered. You would think that after four of these (actually five, but one got done twice) surgeries, I would remember that the healing process takes time…and painkillers are needed to do the exercises to get my finger to fully extend. What I do remember is that it is so important to do the exercises, as much as it hurts, because otherwise… you can negate the whole purpose of the trigger release.
It’s a few days post-surgery and The Kid has developed a fascination with my stitches. I have stooped to use them for bribery. “If you put your pajamas on, you can look at them.” Anything to speed up bedtime.
The world continues to revolve while I am recuperating, so as I gather thoughts about last week (I was up in DC and have a head full of good things to share), I’ll give you some tidbits that you should know about:
- Kim Vlasnik made me cry. Not the Victorian-dab-your-eye-with-an-embroidered-hankerchief quiet cry, but a keening, gasping, aching cry. Her MedX talk captured the essence of what endures beyond the physical and why our community is important. I want to thrust my iPhone at strangers and shout: “Watch her. Listen to her. This. This.”
- Like treasure hunts? The International Diabetes Federation apparently does and is giving prizes out as a run-up to World Diabetes Day (November 14th). Here’s the details. You get pins, bracelets, t-shirts, and bragging rights.
- Yes, it’s almost Diabetes Awareness Month. Much like every year, we will begin to see posts from well-known organizations about the disease and people getting angry that this building and that building won’t light up blue for diabetes when they lit up pink the month before for breast cancer. Here’s a tip: take that anger and put it towards what YOU can do to help raise awareness or advocate for you, your family, or strangers with diabetes in your community or your government. We can light a candle or curse the darkness. You pick. Don’t know where to start? How about here. Or here. Or create something all your own. Every voice matters.
- The World Diabetes Congress (which will be in Vancouver) is calling for abstracts, beginning in February. They are providing 100 grants to attend for individuals from all over the world, which includes the registration and travel costs. What’s my beef? You must be 40 years of age or younger. I’m sorry, but that’s NOT right. I get that there are bright, young individuals who have things to say and want to learn… but there are also those who happen to be over 40 (ahem) who also have things to say and want to learn. To attach an arbitrary cut off age like this is… unacceptable. Yes, I’m going to inquire. Yes, I have something to say about it.
- Heroes sometimes wear shaggy coats. A Sweet Life, one of the best diabetes community media sources, is fundraising with Marjorie. Don’t know who she is? You need to know why she’s important to every.single.one.of.us. - and then help support A Sweet Life.
Off to do my hand exercises, which makes me look like I’m trying to channel The Bangles’ lead singer.
Walk Like An Egyptian.
Whenever she hears that song, the dancing must commence.
No matter what you might be doing, just drop it.
Grab a hand, jump up and down, and wiggle wiggle wiggle.
These are the instructions The Kid gives to me, drill-instructor style, while grinning and giggling.
She makes me happy. Just like these five things you should know about:
1. The Diabetes Technology Society announced the DTS Surveillance Program for Cleared Blood Glucose Monitors.
How important is this?
For those of us who wonder if the number on our blood glucose meter is accurate, it’s a majorly huge thing. Once a blood glucose meter is released to the consumer after approval by the FDA, there is no way to find out if these meters are… accurate. This is the post-market surveillance program that Strip Safely and advocates of meter and strip accuracy have been wanting (and the FDA, too!) - it’s coming!
“This surveillance program will provide a significant benefit to both patients and manufacturers,” says David Klonoff, M.D., founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco. “Patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program.”
Abbott Diabetes Care is already committed to supporting this program and other major manufacturers will be signing on, of that I’m sure. Manufacturers who do not pass the accuracy guidelines at this point will still be allowed to sell in the U.S. market, but I foresee these accuracy reports becoming important in the future as the FDA looks closely at how to ensure our safety with the help of the DTS. Huzzah!
2. The 2014 Diabetes Mine Patient Voices Contest is waiting for YOU.
From the DiabetesMine website:
The 10 top entrants were selected to receive an “e-Patient Scholarship” to attend the DiabetesMine Innovation Summit that takes place annually at Stanford University in Palo Alto, CA. Each year, our winners act as “delegates” for the patient community, expressing our needs and desires to the Powers That Be: decision-makers in pharma, healthcare, technology design, medical device regulation, software and app development, national advocacy groups and more.
This year, the DiabetesMine Innovation Summit will be held on November 10, 2014. Your entry is a product review video for the DiabetesMine Test Kitchen - and it needs to be in by June 19, 2014.
As a 2013 Patient Voices scholarship recipient, I say this:
The DiabetesMine Innovation Summit was a watershed experience for me. The passion of those attending from various communities: medical device, pharma, clinicians, developers, investors, insurance, and patient advocates was electric and infectious. All of us arrived wanting to share how we could work together to make life with diabetes easier using technology. We left with new ideas and a better understanding of what we need to do to make that happen.
If you have the opportunity to attend, do not pass it up. And this is your opportunity to attend this invitation only event!
3. Sweet! Advantame - the newest artificial sweetener to be approved by FDA on May 19, 2014.
For those of us who are stuck with limited choices for artificial sweeteners, here comes Advantame. It’s super concentrated sweet, but here’s the scoop from the FDA’s site:
Advantame is chemically related to aspartame, and certain individuals should avoid or restrict the use of aspartame. To that end, FDA evaluated whether the same individuals should avoid or restrict advantame, as well.
People who have phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Newborns are tested for PKU using a common “heel-prick” test before they leave the hospital.
Foods containing aspartame must bear an information statement for people with PKU alerting them about the presence of phenylalanine. But advantame is much sweeter than aspartame, so only a very small amount needs to be used to reach the same level of sweetness. As a result, foods containing advantame do not need to bear that statement.
So, heads up - it’s chemically related to aspartame (Nutrasweet). I’m a sucralose (Splenda) chick when I use artificial sweetener (I buy Diet Coke with Splenda in can form, and have been known to bring my own 12 packs everywhere…). I try to avoid aspartame, so this new sweetener will be interesting to watch from a marketing perspective.
4. Speaking of Sweet!, I’m over at A Sweet Life, too.
I recently wrote an article about guilt and food and diabetes. See them all traipsing off into the sunset together? That’s what I’m talking about. (Spoiler: They don’t traipse off well.)
There are some stupendous articles written by some of my favorite peeps… and I’m happy to have been asked to add my voice over there. Pop on over and check the site out!
5. Diabetes Hands Foundation has got you in mind: MasterLab for Diabetes Advocates on July 2nd in Orlando.
Want to be a champion for effective diabetes policy? You’re in luck. The Diabetes Foundation will host the very first MasterLab, July 2, 2020 at Marriott’s Orlando World Center in Orlando, Florida! We are excited to offer the first of its kind, action to amplify diabetes advocacy. If you don’t have a background in diabetes advocacy, that’s ok! No previous experience needed.
I never thought I would be an advocate for diabetes. Hell, I never thought I’d be an advocate for anything. It’s funny how life brings you to new places.
I’ve learned a lot since I made the decision to speak up for myself, but I still have a long way to go… and I’m thrilled that this is happening.
Please seriously consider joining us.. Learn more and register here…
And a bonus Fab Friday Happy, because I’m deliriously happy about this…
Register for The Diabetes UnConference. We don’t want to miss you while we’re there, talking about the things that are important to us - people with diabetes.
Now go wiggle, wiggle, wiggle. Make yourself have a happy day.
Less than a year ago, Bennet Dunlap decided that the status quo just wasn’t good enough for us.
We needed to band together as a community to talk about blood glucose meter accuracy and what it means to the 26 million people with diabetes (and growing). Better accuracy begets better control and better outcomes for those of us who rely on our blood glucose meters to give an accurate number. Better accuracy, quite frankly, wasn’t happening.
So, Bennet created the Strip Safely campaign and gave us all a voice under the Strip Safely umbrella. I’m the Robin to his Batman, mostly saying: “Holy glucose meters!” and ensuring our costumes are freshly pressed by Alfred. It’s an honor to work with him and every other person who believes in the importance of blood glucose meter accuracy.
Last summer, Strip Safely attracted the notice of those at the FDA and a relationship began to develop, one that has grown into something important for the diabetes community… and on Monday, you can see for yourself.
This is where all the cool kids will be on Monday… on a Live Chat with Bennet and Dr. Courtney Lias.
(P.S. You are a cool kid, if you were wondering.)
Here’s the details:
Talk with FDA expert Courtney Lias and Patient Advocate Bennet Dunlap about Glucose Monitors and Test Strips
Monday, March 31, 1:30–2:30 pm (EDT)
- Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes?
- Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?
When you participate in this friendly online chat, you will:
- Enjoy an informal, open discussion with a fellow patient advocate, Center for Devices and Radiological Health subject-matter-expert and others in the diabetes community.
- Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes.
- Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.
- Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.
Register for this event and be sure to mark your calendars and join us on March 31st, 2014.
Please let your friends in the diabetes community know about this event. While not all the cool kids will be able to make it, I hope that you’ll join us all on the chat and learn how you can help the community and FDA. We are a community and we can’t do diabetes alone.
Cows are loud when they moo in unison. Unplugged death metal loud. I love their silly little faces and their big tongues that loll out of their mouth when they’re happily eating. (See: any cute animal.)
I miss them. I want them to come home, but until they do, I’m going to rehash the importance of mooing in unison to the FDA.
See, we only have a few cows mooing about blood glucose meter accuracy, and that makes me
sad confused frustrated mooing at deafening decibels in the hopes that you will bring it home.
What the hell am I talking about? (“Is she talking about cows? Huh?”)
Last week, I brought to your attention the need for anyone who is, knows, loves, or might know in the future a person with diabetes. The Food & Drug Administration (FDA) has graciously opened its ears to let us have our say about their proposed changes to the recommendations about blood glucose accuracy.
I’m going to be blunt. (Please try to control your shock.)
Do you not care about blood glucose meter accuracy?
Some of you do. To date, 67 individuals have comments on the Over The Counter Use docket and 16 individuals have comments on the Point of Care docket. (So, besides me, 66 and 15.)
That’s bloody miserable.
How many people with diabetes live in the United States? Over 26 million. (Even with my subpar math skills, I know that 26 million is more than 67.) Of those, more than 3 million are Type 1. (Again, that math thing. 3 million > 67…)
More than 67 people read this blog. More than 67 people read Bennet’s blog. More than 67 people read A Sweet Life.
So, what’s the deal?
Is it not important enough?
Is it not sexy enough?
Miss Manner’s little gaffe ignited a firestorm of responses and comments, but this - having a piece of technology that we rely on for treatment decisions that could send us to the ER or the morgue if it’s wrong - this isn’t something that warrants a comment?
I’m confused. Is there just not enough time in the day to copy and paste? I know, I know… The Internet is filled with very important things like cats and pictures of young James Spader (meow) and someone has to respond to a friend’s status update on Facebook. Or post a video of a cat and a dog snuggling. I get that.
Is blood glucose meter accuracy not as cute? For sure. It’s not cute. It’s not cute at all. Not like cows and kittens and doggies.
Was I not clear enough? Didn’t I explain how easy it was? Did I not speak loudly? Did I not enunciate? E-nun-ci-ate?
I’d love to understand why it doesn’t matter to everyone. Those who have diabetes who might end up on the wrong end of an inaccurate meter because it just didn’t matter enough to comment. Those who pay into the medical system and balk at the thousands of dollars needlessly spent on emergency situations because it just didn’t matter enough to comment?
Every. Comment. Matters.
Your voice matters. Even if it’s not your own words. The more mooing to the FDA, the more important it becomes in D.C… I know.
So, once again, I’m going to moo on this until April 7th - that’s when the cows come home.
Here are the steps - it’s as simple as I can make it for every U.S. citizen. You don’t even need to leave your name on the comment. Not required.
1. Look at the clock. Then copy the info below from “Progress to Conclusion”:
I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypoglycemic range) are a huge step forward. The new emphasis on test strip lot release criteria will hopefully lead to better quality control, and the proposed requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies, and allow users to make informed choices.
The terms “over-the-counter-use” and “prescription point-of-care” use are confusing. Instead, “for patient personal use” and “for professional in clinic use” would make the distinction clearer.
Insulin is a very dangerous drug. Reports show insulin to be a leading cause of adverse drug reaction emergency room admissions.* Insulin is dosed based on meter readings. People with diabetes have a real need for accuracy in our lives, outside the hospital to preventing the adverse insulin reactions that cause ER admissions. Both the patent self use and the caregiver in office use meters should have the same mandated level of accuracy. Dr. David Sacks of NIH suggests the proposed professional standards may not be possible at this time.# Accuracy should be required at the highest level that is economically feasible.
#Close Concerns. 2020-2-27
Currently there is no program in place to review devices to ensure they continue to maintain the accuracy for which they were approved. This allows quality to slip over time, and puts patient health at risk. There should be a post-market surveillance programwith the ability to remove unqualified meters from the market.
There is a wide discrepancy between manufacturers in the number of Medical Device Reports (MDR) that they file.* This is problematic since, as the FDA has stressed, MDRs are essential for the post-market evaluation of glucose meters; failure to comply with MDR requirements puts patient lives at risk. This guidance should require criteria for robust MDR policies, similar to the proposed lot release criteria, in order for a meter to be cleared.
* Close Concerns. 2020-5-27
The FDA stated in a December 2013 clearance document that “Blood Glucose Meter Accuracy is the most important criteria in determining glucose meter quality.” It also indicated in that document that the 2003 accuracy standards (which this guidance would replace) may not be sufficient, because it required the meter in question — which met the 2003 requirements — to be sold with the following all-cap warning: “DO NOT USE [the meter] TO CALCULATE INSULIN DOSES. DO NOT USE [it] TO CALIBRATE CONTINUOUS GLUCOSE MONITORS.”* The new guidance should make clear that only devices which meet the tighter standards can be cleared by FDA to dose insulin or calibrate continuous monitors (and thus be considered DME).
The FDA must also be clear that meters that do not meet the new accuracy requirements should not be considered “durable medical equipment.”
The guidance should explicitly state that the only blood glucose meters that can be considered “durable medical equipment” by payers are those that the FDA determines can be used to “make therapy adjustments” — meaning that they’re accurate enough to calculate insulin doses or to calibrate a CGM. Any meter that does not meet the necessary level of quality (and maintain it post-market) cannot be considered DME, and therefore should not be considered eligible for Medicare/health or private insurance reimbursement as DME for diabetes. (The quoted language comes directly from CMS.)
The proposed labeling requirements should specifically state whether a meter has received FDA clearance to “make therapy adjustments” — a statement that could only be made if the meter and its strips met, and continued to meet, these proposed new accuracy standards. Again, this phrasing would clearly distinguish which meters should be eligible for insurance coverage, since only those that are accurate enough to be used for therapy adjustments should qualify.
The proposed new standards are a positive step, but they can only be effective if they are accompanied by specific quality and labeling requirements that prevent third-party payers from limiting coverage to antiquated meters, and meter/test strip manufacturers from dragging their heels. These proposed changes, when combined with a post-market surveillance system and enforcement policy, will help ensure that I and all people with diabetes are able to safely manage our disease.
2. Click on the link below and paste the stuff you’ve just copied.
3. Click on the link below and paste the stuff you’ve just copied again.
4. Look at the clock. Two minutes? Three minutes?
I’m sorry that it may have taken you away from Facebook or TMZ, but I’m glad you took a few minutes from your life to help save mine and others in the future.
Please moo with me. Please see that while this isn’t sexy or cute, it’s so very necessary. It doesn’t matter if you have diabetes. It will impact you. You know someone with diabetes. You want that person to live well, right? I’m a firm believer in the adage of “If you’re not part of the solution, you’re part of the problem…” Be a part of the solution with us.
I took a little blogging break last week. It wasn’t intentional; I had other things cooking on the burners and gave them the time that was due to them. In the end, it all goes in the same pot, but it was strange to not write. (And that’s the extent of my chef metaphors.)
And now I sit with a large amount of caffeine, thinking about the good things that are happening in the diabetes world. In no particular order…
The Power of Community
According to an unofficial total (but from a source I trust), the Spare a Rose, Save a Child campaign raised…drumroll, please… $26,519. That’s a lot of insulin. That’s a lot of love. That’s a lot of lives that will be saved because the Diabetes Online Community raised their voices as one. I am in awe of the power of this community. For those who shared the message, thank you. For those who donated, thank you. (And it’s not too late to give a rose… )
Just because we’re not shaking the gates in person doesn’t mean that we aren’t working on ensuring blood glucose meter accuracy isn’t on our minds. Larry Ellingson has a guest blog post over at StripSafely.com, asking us all to join him in calling for congressional oversight of meter accuracy. I had the pleasure of meeting Larry at the DTS meeting in September, and I’m glad he believes as we do: whatever it takes to make sure we stay healthy and safe.
Think meter accuracy is not important? Larry gives another statistic that scares me (and it should scare you, too!):
A second survey confirmed that 27 percent of patients with type 1 diabetes had experienced health problems due to inaccurate blood glucose meter readings.
The FDA can only do so much at this point. It’s up to us to rally together to bring Congress the news: we need their help. Bennet and I will be putting together some points that you can use when talking with your representatives soon.
It’s an i-port Advance
Medtronic announced the i-port Advance, an “all-in-one” injection port. For those who take multiple daily injections, it basically takes the place of injecting into different places… and into the injection port. You insert the i-port Advance and for the next 72 hours, you inject into the port.
Injection ports aren’t new. I remember using an injection port years ago. (I don’t remember why. It was probably a sample or two to see if I liked it, but obviously I didn’t care for it, because I didn’t use it for long.) If you have needle phobia, it’s a great way to ease the fear of having to inject more than once a day. If you micro dose fast acting insulin for optimum control, this may be a great way to avoid seven or eight injections each day.
There was a study done in 2008 about the impact of insulin injections on daily life and the results didn’t surprise me much. The study showed that out of 500 subjects, 29% of them stated that injecting insulin was the hardest part of their diabetes care. Fourteen percent of the subjects said that insulin injections have a negative impact on their life. So… obviously there’s a need to help alleviates some of the negativity. The i-port Advance is one way to do so.
The Future of Glucagon
For anyone carrying around that red hard case in the bottom of a bag or a purse or next to your bed, you will nod your head when I say this: Glucagon is a pain in the ass. (Sometimes literally.)
The Glucagon Emergency Kit has been around for quite a while, but unless you’re with someone who knows how to use it, it’s useless. If you pass out, the last thing a stranger will do is rifle through your bag looking for something to help you. Even if you’ve shown a friend or a work colleague how to use it, when push comes to shove (or push comes to drop on the floor), it may be too complicated.
True story: I would give a little primer about my glucagon emergency kit to my staff. New team member = pull it out and go through the motions. I would end every discussion about glucagon with this: “Call 911 first. Then attempt to inject me.” Then the discussion would be who would draw the short straw to do this. I trusted my team, but knew that glucagon was a last resort.
These days, I’m hopeful that glucagon will be available in an easier delivery mechanism - and perhaps even not by injection! Mike Hoskins over at DiabetesMine has a great article about Next-Gen Emergency Glucagon, in which he discusses the big issue: stability of glucagon. (Currently, once mixed, it’s good for 24 hours. After that, pfftt.) But even more exciting? This:
Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes - Yes. It’s a clinical trial that currently is recruiting kids for an intranasal dose… Could this be more awesome? Nope. I am hoping that this is what’s in store for all of us. I’d be much happier giving a primer about: Hold this up to my nose and squirt. Wouldn’t you?
By the way, there’s also a trial for adults: Effectiveness and Safety of Intranasal Glucagon for Treatment of Hypoglycemia in Adults. You can get a little more info here: Evaluate the Immunogenicity of a Novel Glucagon Formulation. The company behind this is AMG Medical, Inc. out of Canada. I’m eager to see the outcome of these trials!
So, as I sit here this morning, I’m buzzing with excitement (or is it caffeine) with hope for the future. What are you excited about?