Catherine Price (www.catherine-price.com) was diagnosed with Type 1 diabetes when she was 22 years old. She has written for publications including The Best American Science Catherine Price is a professional journalist who was diagnosed with Type 1 diabetes when she was 22 years old. Her work has been featured in publications including The Best American Science Writing, The New York Times, Popular Science, The Los Angeles Times, The San Francisco Chronicle, The Washington Post Magazine, Salon, Slate, Men’s Journal, Health Magazine, The Oprah Magazine, and Outside, among others. A graduate of Yale and UC Berkeley’s Graduate School of Journalism Read full bio

Diabetes Vacation: Montreal Edition

As we all know, it’s impossible to take a vacation from diabetes (hence the need for some anti-burnout tips). However, certain vacation destinations and activities are better than others, a fact that I have been thinking about a lot over the past two weeks. Why has this been on the top of my mind? Because my husband and I have been doing a home exchange with a couple from Montreal, and I’ve spent our time here splitting my time between enjoying myself and worrying about my blood sugar. (Home exchanges, should you not be aware of the concept, are exactly what they sound like:  you swap homes with strangers. It’s like Air B&B, except free.) 

First of all, any time I go on vacation — or travel at all — I am shocked to realize just how much my diabetes management depends on my being at home. As a freelancer, I tend to think of my schedule as erratic, and I’m constantly struggling with how to balance the many variables that come with being self-employed. But it just takes two days away from home for me to realize just how many routines I actually have, from my low-carb breakfasts to my gym habits to how much I move around during the day.

I’ve learned that certain “dream” vacations are actually nightmares for me. Sipping frosty drinks on the beach? No thanks. Spending a week in the countryside dependent on a car to get around? Good luck adjusting my basals. But on this trip to Canada — while it certainly has come with its challenges — I’ve begun to think that Quebec during the summer is a really great diabetes destination. Here’s why: 

Bike lanes

This was one of the least scenic of Montreal’s bike paths — but you can still see how it’s set off from the main road by a concrete barrier.

1. Bike lanes. My blood sugar is easiest to control when I get regular physical exercise, ideally things that are aerobic but not too strenuous (lest my stress hormones send my blood sugar spiking). When traveling, I usually walk a lot, which is a great help. But here in Montreal, I have a different option: biking! I’d read before we got here that Montreal is considered a biker’s paradise, and I have to agree. Not only is there a citywide bike-sharing program (called Bixi) but there are bike lanes everywhere. EVERYWHERE.

And I’m not talking about painted lines on the road that cars may or may not decide to respect (or that UPS trucks may or may not decide to use as a parking spot). I’m talking about designated bike lanes (and sometimes even paths) that are completely separate from the main road. The apartment we’re staying in is right near the Old Port of Montreal (and the people we’re swapping with lent us their bikes), so the first weekend we were here we biked about 50 kilometers — ALL ON BIKE PATHS!!! — down the Lachine canal, to a beautiful park, and back. Today we went to an architectural salvage place about 10 kilometers from the house, then to the Jean Talon market, and then home — again all on bike lanes. Last night we went out to dinner at a place about 5 kilometers away . . . and guess how we got there? Even better than biking to dinner is biking back afterwards, especially when there is a free fireworks performance going on in front of you as you ride. A post-prandial ride, plus a show? Yes, please. (And there are tons of bike lanes throughout the entire province of Quebec. Check out La Route Verte for a sense of how extensive they are.) 

My idea of heaven.

2. Strawberry season. Strawberries are one of my favorite foods of all time, and we happened to get here just at the beginning of strawberry season. I cannot tell you how excited this makes me. I have been eating at least one pint per day (oh, how I love fruits that are as low in carbohydrates as they are high in deliciousness), and in addition to making me extremely happy, this habit is keeping me from eating other Quebec specialties, like maple syrup, or inch-thick slices of fois gras. My vitamin C levels at the moment are through the roof. 

3. Cheese. Not only is it zero-carb but I went to a fromagerie (that’s French for “store of amazing cheeses”) and saw an ad at the checkout claiming that cheese is good for you because it’s high in a number of vitamins. I love any country that tells me that brie is a health food. 

Cheese: 0% carb. 100% delicious.

0% carb. 100% delicious.

4. Hikes and walks. We’ve been walking a lot in the city itself (I find city vacations to be diabetes-friendly), but we also took a trip up to Charlevoix, which is an area north of Quebec known for its artisanal food producers (think more cheese and produce, plus tasty duck products) and beautiful landscapes. We found a number of great hikes and walks, including one in Tadoussac that was a very easy (though diabetes-friendly) stroll along a pine-scented trail overlooking a fjord that ended at a, wait for it, BELUGA WHALE SANCTUARY. I’ve since decided that anything involving charismatic megafauna is by default good for my blood sugar. 

5. Speaking of blood sugar, my new favorite low-blood sugar treatment: maple sugar candies. I used to love these things when I was a kid (before I had diabetes) — you know, the compressed sugar candies in the shape of a maple leaf that melt in your mouth. Needless to say I do not eat many maple syrup candies these days. But I figured that while I’m in Canada, they might be a good replacement for my Dex4 tablets and my Gu.

These are mostly gifts. Except for the candies. Those are mine.

 6. Lastly, I want to put in a plug for home exchanges themselves as a diabetes-friendly way to travel. I find breakfast to be one of the most challenging parts of traveling with diabetes, but if you’re doing a home exchange you’ve got access to a kitchen and a fridge, which means that you’ll be able to replicate your home habits while traveling. I find this to be enormously helpful in getting the day off to a good start, blood-sugar-wise. And of course, you can also cook your own lunch and dinner, which both saves you money and enables you to resort to frittatas, should the maple syrup candies prove too tempting. 

In short, Montreal (and Quebec) gets a big thumbs up from me. How about you? What are some of your favorite blood-sugar-friendly vacation destinations and activities?

 

 

  

 

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Metformin and Type 1 Diabetes – An Experiment

Metformin is not usually prescribed for Type 1 diabetes, but over the past couple years, inspired in part by Mike’s experience on it (see here, here, here and here), I’ve become interested in trying it. Not only has it been in widespread use as a treatment for Type 2 diabetes since its approval in 1994, but it’s currently being investigated for potential cognitive and anti-cancer benefits as well. As Mike has asked, “Could metformin be the new aspirin?” 

The typical explanation for why metformin is not prescribed to people with Type 1 diabetes is that metformin increases your insulin sensitivity — and given that, by definition, people with Type 1 don’t make any insulin, it won’t help them. But I see two obvious holes in that logic. First, people with Type 1 diabetes do have insulin in their bodies; it’s just administered in a different way (i.e. injected subcutaneously, rather than secreted by the pancreas). And as anyone who’s struggled with the dawn phenomenon knows, people with Type 1 diabetes experience insulin resistance, too.

And second, metformin does more than just affect insulin sensitivity. It also appears to regulate the genes responsible for causing the liver to release glucose into your blood. As you may know, your pancreas and your liver work closely together to maintain a proper level of glucose in the blood. When you’ve got a lot of glucose in your blood, your pancreas secretes insulin to remove it (provided you don’t have Type 1 diabetes!). And when you don’t have sufficient external glucose – like when you’re sleeping — your liver releases some stored glucose so that your blood sugar does not drop too low. To put this a different way, insulin is what keeps a non-diabetic person’s blood glucose from getting too high; the liver (by releasing glucose stores when appropriate, triggered by the hormone glucagon) is what keeps a non-diabetic person’s blood sugar from going too low. 

I feel like I have an extremely overactive liver, which seems to take any excuse it can get to dump additional sugar into my blood stream, whether it’s needed or not. And I also seem to have difficulty absorbing the insulin delivered by my pump. So I was really excited when my doctor allowed me to start trying metformin a couple weeks ago.

When I picked up my first prescription, I decided to ask the pharmacist for some advice — namely, what sort of side effects I should watch out for, given that I’d read stories online about uncontrollable vomiting. But no, she said, in front of the group of people waiting behind me in line. The most frequent side effect is diarrhea.  That’s why they start you on a low dose. 

With that noted (both by me and my fellow shoppers), I went home and took a pill with dinner, and gave myself a bit less insulin than I’d normally take (since metformin increases insulin sensitivity it also comes with an increased risk of hypoglycemia for people taking artificial insulin — i.e. Type 1s; see below). Then I waited to see what would happen.

I’m happy to say that in terms of my pharmacist’s warnings I was lucky: no GI upset. And I’m even happier to say that starting with the very first dose, I began to notice a difference in my post-meal blood sugars. Not only did my blood sugar start to rise more slowly than normal after eating (which itself is fascinating — I’d always thought I absorbed food very quickly, but perhaps what’s really going on is that my liver is dumping glucose into my blood right after I eat), but the post-meal line on my Dexcom was much smoother than normal. 

I can’t remember what I ate for dinner the first two nights, but I can tell you this: my total daily insulin dropped from about 22 to 25 units per day to between 15 and 20. Considering that about 10 of those units are basal, that’s a really big reduction — in the most extreme case, we’re talking 5 units of bolus insulin per day. (Granted, I eat a very low-carb diet, but still.) I felt an eerie sense of ease — as if the metformin were somehow making my diabetes . . . dare I say it . . . simpler, and easier to control. It was an amazing feeling. 

That was about two weeks ago, and I’m now up to a full 1000 mg daily dose (in my case broken into twice daily 500 mg tablets). My past 5 days’ worth of totals (including basal insulin) are: 18.35u, 14.65u, 15.975u, 17u and 21.8u and my blood glucose hasn’t spiked above 200 mg/dl. (Again, I eat an extremely low-carb diet, am on a Dexcom CGM in addition to a pump, and am a wee bit obsessive — but even with all that, this is unusual for me.) When it comes to my own diabetes management, I am a Metformin believer. 

With that said, a major caveat: in addition to whatever it’s doing with my liver, the metformin also definitely increases my insulin sensitivity. I have had more lows these past two weeks than normal (which I figure is to be expected as I learn how to use it), and I have had to drop not just my mealtime boluses, but some of my basals as well. I do not recommend trying any of this without direct supervision or help from your diabetes doctor or endocrinologist, since the risk of hypoglycemia increases for people with Type 1 (it’s not a problem for people who are not on artificial insulin, which is why hypoglycemia is not typically an issue with metformin and non-insulin-taking Type 2s). In other words: this is not medical advice!

But with that said, I’m personally pretty excited. Stay tuned for further updates. And if you’ve had experience yourself with Metformin and Type 1, I’d love to hear about it in the comments section. 

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DBlog Week: Change the World!

It’s day one of the 5th annual Diabetes Blog week (organized by the amazing Karen Graffeo at Bittersweet Diabetes), and today’s topic is “Change the World.” The assignment? 

“Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you ‘formally’ advocate for any cause, share the issues that are important to you.”

Um, yes, yes, and yes! I have been sitting at my desk for about 10 minutes now staring at that prompt, wondering where to possibly begin — I find that once I start dipping my toes into anything related to the world of diabetes advocacy, it’s hard (for me at least) to resist being pulled underwater. There’s so much that concerns me, from poorly executed news coverage of diabetes, to CMS’s shortsighted competitive bidding process for diabetes supplies, to the issue of inaccurate blood glucose meters and strips, to Medicare and Medicaid’s refusal to acknowledge continuous glucose monitors as worthwhile (and I’d argue essential) tools in diabetes management. Sometimes working on this type of stuff exhilarates me — for example, the recent decision by Arizona’s legislature to reinstate insulin pump coverage for adult Medicaid recipients was thrilling. But other times it just feels overwhelming, especially when it’s coupled with the constant task of managing my own blood sugar. I feel like diabetes already is a full-time job, and it’s hard to add advocacy on top of my other full-time job (writing) and not feel a bit like I’m drowning. There’s so much to do, and always more to be done. 

With that said, I’ve noticed something personally positive that’s begun to come out of getting more involved in advocacy: a sense of community. I’ve spent the past decade or so as a freelance journalist, and while the autonomy is invaluable, it can also be quite isolating. And when it comes to diabetes, no one in my daily life — save my wonderful husband — really knows much about what it takes to manage your own blood glucose day in and day out. I’ve noticed that whenever I see pump tubing come out of someone’s pocket, or hear the familiar beep of another person’s CGM, I get a little teary — which I take to mean that diabetes often makes me feel much more alone and overwhelmed than I realize. So it’s been wonderful to begin to connect with other people with diabetes through these advocacy efforts — people who understand exactly what it’s like to act as your own pancreas, and who are passionate about the same diabetes-related issues as I am. Not only do I feel hopeful that our collective efforts are making a difference, but I also feel like I’m a part of a community — an inclusive and informal group of people all struggling through the same medical stuff, and fighting for the same type of change.

But let’s get back to the actual prompt: what is it that I feel most passionately about? I think that for me, it’s two things. First, helping other people — whether it’s insurers, reporters, CMS, politicians or the general public — understand what it’s actually like to live with Type 1 diabetes, in hopes that it will lead to better coverage for diabetes-related drugs and devices. I want there to be an artificial pancreas — a real closed loop system that alleviates some of the emotional burden of the disease and reduces complications — and I want to do all I can to ensure that all people with diabetes have access to it. I want to encourage people to participate in clinical trials in hopes that somehow, someway, some day, we actually have a cure. Diabetes sucks, and I want to do what I can to make it better.

And second, I want to write about diabetes in a way that puts other people’s subconscious experiences with diabetes into words. Diabetes is isolating. My goal is for people to read my blog, or article, or whatever, and nod their heads because they feel that way, or have experienced that thing, too.  I want to use my writing to find the humor and absurdity in life with this crappy, crappy disease, maybe even make people laugh about it a bit (even though it can also sometimes make you want to cry).  And I want to use my writing to try to help other people with diabetes — not to mention myself — feel a little less alone. 

 

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The Problem With Generic Test Strips

In concept, generic blood glucose test strips sound like a great idea. Made by 3rd party manufacturers (i.e. a company other than the one that makes your meter), they often (claim to) work with a variety of different meters, and tend to be much less expensive than their counterparts. Given that big-name test strips can cost $1 to $1.50 a pop, it makes sense that people with diabetes (not to mention insurance companies and government payers) would be eager for a cheaper solution. 

But there’s a problem: those cost savings are only relevant if the generic test strips are accurate. If they’re not accurate, then you may miscalculate your insulin dose. And if you miscalculate your insulin dose, you could die.

(To put it a different way, if a blood glucose test strip doesn’t accurately measure your blood glucose, then it’s not technically a blood glucose test strip. You might as well read tea leaves.) 

Personally, I can’t wrap my head around the fact that there is currently no system in place to ensure that test strips that have been cleared by the FDA for sale continue to meet those accuracy standards after they’re on the market. (But it’s true: there’s not.) 

I also can’t get over the fact that Medicare continues to insist that there have been no negative effects of its recently implemented competitive bidding program for mail-order diabetes supplies — despite evidence (for example, this study from the American Association of Diabetes Educators) clearly indicating that the program is restricting people’s access to blood glucose testing supplies, and pushing them — often against their will — toward problematic generic meters and strips. (Important note: they’re not allowed to do this! Scroll down on this page for more information.)

But in the rare moment when I think to myself, “Hey, Catherine. Maybe it’s not such a big deal!” something always seems to come up to snap me out of my reverie. An example of this happened just yesterday, when I received a safety notice from the FDA about Shasta Technologies’ GenStrip Blood Glucose Test Strips. (The company previously received an FDA warning letter.) If I may quote: 

“During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. . . At an inspection earlier this year, and documented in an April 2014 warning letter, the FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. . . . To date, the company has been unwilling to voluntarily recall their test strips, resulting in their continued availability. The FDA recommends that use of Shasta Technologies, LLC GenStrip Test Strips be discontinued.

(Emphasis mine.)

Really?

This is not the first instance where third-party generic test strips (or low-cost meters) have been found to be problematic. (See also: this weird language from the FDA for a meter cleared last December.)  Indeed, Mike Hoskins recently did a great feature about the issue, which, given yesterday’s notice, has proved to be disturbingly prophetic. 

The company that now makes the GenStrip test strips issued a response to the FDA’s notice today, essentially claiming that the problems have been solved, those particular strips will be replaced at no charge, and that a new, rebranded version (of the same product) is soon to be launched that presumably will not have accuracy issues. Frankly, I’ll believe it when I see it — and also, as far as I can tell, this is not an actual recall, as might seem to be appropriate given the potentially deadly consequences, but rather an offer for proactive and educated customers to get replacements. 

It’s worth stressing here that the cost of test strips is obviously quite high, and that there is a need for lower-cost solutions. But cost does not — and cannot — trump accuracy. 

If you agree that accuracy is an important issue, and that the makers of 3rd party strips should be held directly accountable for the quality and accuracy of their products, please consider adding a comment to the FDA’s Draft Guidance on Blood Glucose Meters, which is open until an extended deadline of May 7th. 

For more information (and suggested comments), visit StripSafely.com (And here are my previous suggestions for other comments you might want to add, in addition to whatever you want to say about the issue of 3rd party strips.)

You can also learn more about the draft guidance as a whole by watching the FDA’s patient network’s March 31st live-chat on the subject (the first ever of its kind!) in which the FDA’s Courtney Lias and Helene Clayton-Jeter sat down with StripSafely.com creator Bennet Dunlap to have an informal conversation about what the guidance says and what the agency would like feedback from the public about. 

Also, consider leaving a review (referencing or directly quoting from the FDA’s notice) on the Amazon page for the meters and strips in question — it could help save people’s lives. (Here’s one example — but there are many other test strips made by the same company.) People need to know about these quality concerns, and (especially since the company itself is not doing a recall), Amazon is a great way to spread the word.

Again, the deadline for FDA comments is May 7th (and it only takes a few minutes). Goodness knows the 3rd party manufacturers are going to make their opinions known. Shouldn’t we do the same? 

 

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FDA and Patient Live Chat: The Recap

As I mentioned earlier, today marks a huge day in the diabetes community’s collaboration with the FDA, the government agency in charge of regulating America’s drugs and medical devices: Courtney Lias, the director of the division at the FDA that regulates blood glucose meters, insulin pumps, continuous blood glucose meters and other diabetes-related technologies just did a live-chat with the inimitable Bennet Dunlap, creator of Stripsafely.com and tireless patient advocate. The moderator was Helene Clayton-Jeter, one of the masterminds at the FDA’s Office of Health and Constituent Affairs, which is responsible for the FDA’s Patient Network website — a cool resource which houses the agency’s diabetes web page, among many other things.

The subject? How people with diabetes can work with FDA to ensure that we all have access to safe, high quality blood glucose meters and supplies. 

From left to right: Clayton-Jeter, Lias, and Dunlap.

 

 

 

 

 

 

 

 

 

 

 

 

Here’s a quick recap:

First, if you missed the live-chat and want to see it, it will be available soon from the FDA’s patient network site for diabetes – which is also where you should go to sign up for updates on how the FDA is collaborating with patients about diabetes-related issues. As noted, it’s definitely worth checking out. 

Second, if you think this chat was a good idea (spoiler alert: I think it was an AWESOME idea), please please let the FDA know. (They like affirmation, too!) You can do so by sending a tweet to @FDADeviceInfo (and perhaps use the hashtag #DOCasksFDA). Also please comment on this post. This was a really innovative and unusual thing for them to do, and it’d be nice for them to hear our feedback. (Over 500 people signed up to watch/participate in the chat, which hopefully will also send a positive message!)

A bit more info: I have written about the FDA’s proposed draft guidance for meters and test strips before, so please check out that story (or visit StripSafely or see Mike Hoskins’ summary of the issue) if you want the background. In short, a “draft guidance” document is basically the FDA’s thoughts on what factors it will consider before deciding whether or not a particular meter (or other diabetes technology) will be cleared for sale. The last (and, incidentally, first!) guidance on the subject was published way back in 2003 — and was developed with very little direct patient input. So it’s now our chance to make our voices heard. 

The deadline for commenting has been extended to May 7th. So please, PLEASE submit your comments to the FDA’s draft guidance! You can find out how to do so (and read some suggestions of what to say) here. 

In addition to those suggestions, I also suggest that you consider requesting that the FDA do something about the accuracy of meters currently on the market. At the moment, the draft guidance is written in such a way that today’s meters would be grandfathered in, regardless of whether they have accuracy issues. During the call, Lias made it clear that if the patient community wants the FDA to incorporate more proactive language — that is, take affirmative action on today’s meters, rather than simply let them “sunset” out, we need to say so. 

I also anticipate that the FDA might get a lot of push-back about its proposed requirement for accuracy information to be published on the front of the box. This is a HUGE deal for people with diabetes, since it would a. make clear that not all meters are equally accurate, and b. provide an incentive for manufacturers to prioritize accuracy when developing new meters. It may also be possible to leverage this information to influence which meters are (and are not) covered by insurance payers. If you agree, PLEASE make this clear in your comments to the FDA. Consider including something like “I applaud FDA for its proposed front-of-box labeling requirements for blood glucose meters. This will allow customers to make educated decisions, and motivate manufacturers to improve the accuracy of their products. This is an essential part of the proposed draft guidance and should be included in the final version.”

Likewise, if you believe that the FDA should have a system to ensure that meters and strips continue to meet accuracy standards even after they’ve been cleared for sale (i.e. that there should be a post-market surveillance program), please indicate that, too! (“I believe that there should be a post-market surveillance program to ensure that meters and strips continue to meet the accuracy standards on which their FDA clearance was based.”) The FDA is trying to work with the patient community on this issue, and the more we can emphasize this issue and support the FDA in its attempts, the better.

And also: please be sure to praise the parts of the draft guidance that you like. This is not just a request from the FDA for praise; it’s essential in order to make sure that the stuff we like doesn’t get stripped out. As Lias said during the chat, “First and foremost if you agree with something in guidance document please include it. If someone else disagrees we’ll only hear their side.”

Lastly, be sure to add your personal story! It may seem strange to do so, given the formal tone that many comments can take, but the FDA really, really wants to know how the drugs and devices it regulates affect the lives of patients. So if there’s anything you wish the FDA knew about how you use your blood glucose meter, or which features are most important, or what you wish the draft guidance had said, speak up! Just as there are no stupid questions, there are also no stupid comments. Make it personal.

In the interest of brevity, I’ll end this (so you can go comment on the draft guidance — it takes two minutes!). If you have additional questions on this issue, leave them in a comment to this post and I’ll try to answer them.

In closing, I’ll leave you with these comments from the FDA’s Courtney Lias:

“It’s really been great to hear how engaged the patient community is on this issue. We [at FDA] want to get a good sense of what you want so we can try to get devices out there for you that meet your needs better than the ones you’re getting now. . . . We want patients to tell us what they want and what they need.” 

The ball is in our court. Submit your comments NOW. And let’s extend a huge thank you to StripSafely.com’s Bennet Dunlap and the FDA’s Courtney Lias and Helene Clayton-Jeter for putting together such a revolutionary and inspirational event. It’s great to be working together.

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Diabetes and the FDA: A First-Ever Live Chat

Ain’t no party like an FDA party.

I’m being serious. This Monday, March 31st, the FDA’s Courtney Lias and StripSafely.com‘s Bennet Dunlap will be hosting a live chat about blood glucose meters – and you’re invited.

Lias is the director of the division of toxicology and medical devices at the Food and Drug Administration (that’s the FDA department that oversees blood glucose meters, pumps, CGMs and other diabetes technologies). As I’ve mentioned before, I’ve heard Lias speak and have been extremely impressed by her desire to engage with the patient community — she seems truly committed to listening to and connecting with the people who depend on the technologies that her department oversees. If you ask me, that’s pretty darn cool.

And Bennet, should you not already know him, is one of the masterminds behind StripSafely.com. Father of two kids with Type 1, personally at risk of developing Type 2 himself, he writes the blog YourDiabetesMayVary and is a tireless advocate for people with diabetes. Spend five minutes with him and you’ll walk away not just with a StripSafely lapel pin, but with a newfound belief in the power and importance of patient engagement. (Bennet was one of the instigators behind last week’s push to encourage Arizona’s house of representatives to reinstate insulin pump coverage for adult Medicaid recipients — an effort that, thanks to the participation of people like you, appears to have been successful!)

Bennet, too, is pretty darn cool. And he’s really, really involved in the really, really important effort to figure out a way to ensure the accuracy of blood glucose meters and test strips. This is a big issue at the moment, not just because of the issues with test strip coverage caused by Medicare’s recently rolled out (and disastrous) competitive bidding program for diabetes mail order supplies, but because of ongoing accuracy issues with meters, and the lack of a post-market surveillance program.

So here’s why I’m excited: on Monday, March 31st between 1:30 and 2:30 Eastern time, Dr. Lias and Bennet are joining together to host a ground-breaking live online chat about glucose monitors and test strips! You can read more about the chat — and sign up for it — here. To quote from the FDA’s announcement: 

  • “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, CDRH 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.”

Translation: this is your chance to communicate with (and ask questions directly to) the FDA about its approach toward the medical technologies and devices that we rely on each day. (Note: this is not about diabetes drugs, just devices.) It’s the first event of its kind, and I encourage everyone who can to sign up  – and bring some questions!
 
Also, if you haven’t done so already, tomorrow’s chat is a great opportunity to figure out what you’d like to say in your comments about the FDA’s new draft guidance for blood glucose meters — a document which outlines the FDA’s new proposed standards that products would have to meet before being cleared for sale. The period for public comment closes April 7 and it is very important for us in the patient community to submit our thoughts and suggestions, so that they can be considered by the FDA when it drafts its official guidance documents. I’ve explained this in more detail and listed some of my own draft comments — which you can feel free to crib from — in my previous run-down of the FDA’s draft guidance; you can also learn more at StripSafely.com. According to Bennet, there are already at least 318 comments on the draft guidance comments — let’s see if we can reach 500! (Many of those 318 are likely from test strip manufacturers, so it’s especially important for us to add patient voices to the mix.)
 
In short: Monday marks the first-ever patient/FDA live chat on diabetes, and will give you a chance to ask your own questions about how the government regulates blood glucose meters and other diabetes devices, and have your suggestions heard. It’s free, it’s from 1:30-2:30 eastern, and it’s going to be great.
 
You can sign up here.
 
Will you join me?

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Minimed 530G with Enlite Trial, Threshold Suspend

Last week I started a trial of Medtronic’s latest insulin pump and continuous glucose monitoring system, the Minimed 530G with Enlite. (See my previous post here.) I thought I’d devote today’s post to what’s arguably the most exciting part of the new system: threshold suspend. 

As those of you who have been keeping up with the work toward developing a closed-loop insulin delivery system (the so-called Artificial Pancreas) know, threshold suspend is the first step in the long journey toward that goal. (You, like me, may also have been irritated by the marketing that surrounded the 530G and used the word “artificial pancreas,” since it was picked up and oversimplified by the news media to suggest that this system actually is an artificial pancreas, which it is most definitely not.) 

Threshold suspend, which has been available on Medtronic’s Veo pump/CGM system in Europe since 2009, means that if your blood glucose reaches a certain predetermined level (anywhere from 60-90 mg/dL), your insulin pump will alarm, warning you of a potentially dangerous low. If you respond to the warning, nothing will happen.  Minimed 530G with Enlite Trial, Threshold SuspendBut if you do not respond to that warning, the pump will shut off basal insulin delivery for two hours. (Then it will go on for four hours, then off for another two, etc, till someone clears the alarm.) The idea is simple: if you’ve got a low blood sugar and are not responding, the last thing you need is more insulin. 

When I set up my 530G system last week, I was hoping not to have to experience the benefits of Threshold Suspend firsthand. I’m lucky enough to never have passed out or been sent to the hospital as a result of a low blood sugar, and thanks to my CGM, usually am able to stave off bad nighttime lows. So I was surprised when I found myself roused from sleep my first night on the system by two-tone alarm of my pump going off, and the message on its screen that said Threshold Suspend. A quick scan of my body confirmed what it was suggesting: my heart was racing, and I felt shaky. My blood sugar was indeed low. And whereas I’m normally able to correct for a low with two glucose tablets (even that sometimes sends me too high), that night I took five glucose tablets and never had a spike above 130 mg/dL. In other words, I’m glad that it went off. 

With that said, I’ve also found some things about the Threshold Suspend function to be unsatisfying/annoying. First, it isn’t predictive, meaning that it will only shut off once you’ve already reached your predetermined target (the next generation will hopefully have this capability). But second, there are some aspects of Threshold Suspend that I worry will limit its use. For example, you can only set your limit from 60 mg/dL to 90 mg/dL (kind of odd, since you can set other aspects of the pump as low as 40 mg/dL). I have mine set at 60 mg/dL, as low as it’ll go, but I don’t think it’s low enough: I often touch 60 mg/dL over the course of the day, and I don’t consider those lows to be emergency situations, since I’m alert and easily able to correct it. I would like to have the option to set it lower.

Second, I would like to be able to create two targets for Threshold Suspend: one for the nighttime, and one for the day (and a temporary snooze function). I say this because, as mentioned, a low of 60 mg/dL when I’m alert and awake is not an emergency situation. But the pump’s Threshold Suspend function INSISTS that it’s an emergency. The alarm does not start with a vibration — it goes straight into full on alarm mode. This means that if you are in a situation where you don’t want to risk having a siren emanate from your body — say a meeting or interview or yoga class — then your only option is to turn off Threshold Suspend. That might be fine for the moment, but it puts you at risk of forgetting to turn it back on for the times you really do need it, particularly before you go to sleep. And if the sensor is giving you an inaccurate reading — which is quite possible on any CGM system — then it’s even worse: you can have your pump start to go bat-sh*t crazy on you when you aren’t even low. 

All this brings up a point that I predict I will be reiterating throughout this trial: I wish that there had been more patient input in the design of the 530G, particularly when it comes to alarms. I do not know what type of trials were done before the system was submitted to FDA for approval, but I cannot imagine following a real person with tightly controlled diabetes around for three days and not concluding that the current limits for Threshold Suspend are too high, and that you should be able to set different limits for different times of day (and that the nighttime alarm should be louder — by the time I woke up, insulin delivery had already been suspended). As it is now, I really do worry that the annoyance of having a siren go off every time my blood glucose hits 60 mg/dL is eventually going to make me either turn it off (and forget to turn it back on), or turn it off entirely. And that would defeat the main added benefit of this particular pump.

With that said, I think that the Threshold Suspend feature of the 530G system is a great advance in diabetes care. I also think that integrated pump and CGM systems — especially those that can ward off potential dangerous lows — are essential for people with diabetes, and I believe that insurance companies and payers like Medicare should cover them. That’s probably the most important message of all. 

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Minimed 530G with Enlite Sensor Trial, Day 1

When Medtronic recently offered me the opportunity to do a free trial of the Minimed 530G with Enlite Sensor, their new pump and continuous glucose monitoring system, I jumped at the chance. (Disclosure: I have to give it back at the end of the trial period, and they have no say over what I write. Right now I wear the Medtronic Paradigm Revel 523, and the Dexcom Platinum G4 CGM.) Not only am I a diabetes dork and self-experimentation enthusiast, but I genuinely am interested in whether I might eventually be interested in switching over. 

I’m planning on writing a series of blog posts about the experience — so let’s start with the basics.

After an initial call last week from Sheryl, my StartRight program contact (StartRight is Medtronic’s new six-month support program for new customers or people upgrading their systems, and seems pretty awesome), I met my trainer, Lindsay, at a coffee shop this morning to get started with the system. 

I’d already checked out some of the gear myself — or, I should say, the packaging, which Medtronic recently redesigned to provide users with a less overwhelming and intimidating initial experience. (Some people had been so overwhelmed when they opened the box that they sent the pump back without even trying it.) So now the pump and CGM come in a special suitcase that you can bring with you to your training session, without having to worry about whether you’ve got what you need. In addition, the boxes themselves have been redesigned to look more like an Apple product than a medical device. For example: 

Is it a pump? Or is it an iPad?

 

The pump itself doesn’t look that different from the Paradigm Revel. 

 

It’s a good idea, especially when you imagine what it’s like to initially consider going from this:

 

 

to this:

 The first important thing to know about the Minimed 530G with Enlite is that it’s an entire integrated system — so that’s what I’ll devote the rest of this post to describing.

One part is the Minimed pump, which is what actually delivers the insulin. (As pumpers know, the pump is not “smart” — it can’t decide dosing itself — but it makes it much easier to customize your basal rates and make precise adjustments.) And the Minimed 530G is also the first insulin pump approved in the US that has “threshold suspend.” I’ll write more about this feature later, but the basic idea is that once you reach a predetermined number — say, 60 mg/dl — the pump will sound an alarm to make sure that you are alert and conscious (in which case you simply clear the alarm). If you do not respond to its alarm, then it will make a very loud noise, and go into “threshold suspend” mode, which means that it will halt the delivery of basal insulin for 2 hours or until you clear the alarm, whichever occurs first. The idea, of course, is to prevent making a low blood sugar worse by pumping in additional insulin. Again, more on this later.

The Minimed 530G Insulin Pump

The next part of the system is the Enlite continuous glucose monitoring system, which reads your interstitial glucose levels and transmits them wirelessly to the pump, which will then alarm if you go too high or too low. (As a side note, some insurance providers — hello, CMS! — don’t believe in the value of CGMs because you’re not supposed to actually dose insulin off them. To which I would like to point out an alternate definition of them, provided courtesy of StripSafely.com‘s Bennet Dunlap: by alerting you to severe hypos, they actually can be considered “death avoiders” — which seems to me like a pretty important purpose, and one which Medicare JUST MIGHT WANT TO COVER.) 

Enlite sensor

Enlite sensor and transmitter — this is the part of the CGM that you wear on your body

But I digress. The third part of the system is Bayer’s Contour Next Link blood glucose meter. This is the blood glucose meter that the FDA has specifically approved as part of the Medtronic system, and it’s pretty cool: when you test your blood sugar on the meter, it automatically logs the number, asks you if it’s before or after a meal (or neither) and sends the information to your pump. The pump then asks you if you would like to use that number to calibrate your continuous monitor (eliminating the need for manual entry) and also puts that number automatically into your “bolus wizard calculator,” which is a tool built into the pump that helps you calculate a proper insulin dose. 

Bayer Contour Next Link Blood Glucose Meter

What’s more, one side of the Next Link is actually a USB dongle — which gets me to the fourth part of the system: the CareLink Personal Management Therapy Software. Once you’ve created a CareLink account, you can plug in your dongle (heh), and the software is able to input all the info from not just the blood glucose meter, but from your pump and the continuous glucose monitor as well. You can then view this combined data on a variety of different graphs and overlays (I will write more about it once I’ve played around), and you can share it with your doctor or diabetes educator or anyone else you think might be interested. What’s more, since CareLink is based in the cloud, you can use it on either PCs or Macs (hallelujah!), and it automatically synchs between your devices. 

***An important coverage note: if you are on the Medtronic system and your insurance company says that it will not cover the Bayer strips, talk to your doctor about writing a letter of medical necessity saying that you require those particular strips. If that doesn’t work, contact Medtronic directly and ask them for help/guidance — if you’re on the 530G with Enlite system, there should be a way to get an authorization to get these specific strips. This is also true for people on mail order — if your mail order supplier tries to switch you to a different meter, PLEASE contact Medtronic or your StartRight representative and ask for help. The mail order supplier is supposed to be getting you these particular strips. (With that said, if you don’t want to use the Bayer meter you also can pick a different one and manually input blood glucose values; you just need to get a CareLink dongle, available from Medtronic, to get the data from the pump into your computer.)***

So that’s the basic overview of how the system works. It’s the first — and only — system in the US in which a CGM and pump communicate with each other directly. (Johnson & Johnson has submitted an integrated Animas Vibe pump/Dexcom CGM system to the FDA, but it has not yet been approved, and while Tandem and Dexcom have a similar plan, it’s not yet been submitted.) It’s also the first system in the US to have low threshold suspend. And it’s also the first system where the data from all three components — pump, CGM and blood glucose meter — can be easily displayed in one software management system. And I have to say, as someone who’s spent the past five years or so on a Dexcom CGM, Medtronic pump, and Abbott blood glucose meter, this smooth integration is really, really nice. 

For my next post, I’ll talk about getting started on the system. If you have any specific questions you’d like me to try to answer during the course of this trial, please leave them in the comment section.

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What Do Your A1c Test Results Really Mean?

The hemoglobin A1c test, as we all know, is supposed to give a sense of your average blood glucose levels over the past three months. But here’s a question for you: have you ever tried to figure out what those average blood glucose levels actually are? Say you have an A1c of 6.5% — what, in mg/dl, does that translate to? 

Try searching Google — it’s hard to find an answer. To quote from a post I wrote a few years ago (see entry from 4:45), that’s partially because:

“Not only is there no one standardized definition as to the correlation between A1c and mean glucose levels (JDRF says 1% = 24.4 mg/dl, ADA says 28.7), but different people have different correlations. For example, if you are a ‘high glycolator’ (more glucose sticks to your hemoglobin than the average)  you can have a relatively high A1c but a low mean glucose. The speaker gave the example of a patient who had a 8.2% A1c, but a mean glucose of 159 mg/dl (he was speaking using the generally accepted idea that 7% roughly equals a mean of 154 mg/dl). Treat him more aggressively, and you’ll end up with hypos. And if you’re a ‘hypoglycolator,’ it’s the opposite.”

Well, just this week, a new paper was published in the American Diabetes Association’s Diabetes Care journal that provides a more solid answer to this question than I’ve seen — even though, as I must warn you, personal variability (as described above) means there’s still no precise answer. In the study, researchers wanted to find out what your average blood sugar would have to be in three situations — fasting, after meals and before bed — in order to achieve a particular A1c. 

Here are their results: 

A1c test results of 5.5-6.49% were associated with an average fasting blood glucose level of 122 mg/dl.

A1c test results of 6.5-6.99% were associated with an average fasting blood glucose level of 142 mg/dl.

A1c test results of 7-7.49% were associated with an average fasting blood glucose level of 152 mg/dl.

A1c test results of 7.5-7.99% were associated with an average fasting blood glucose level of 167 mg/dl

A1c test results of 8-8.49% were associated with an average fasting blood glucose level of 178 mg/dl.

The abstract only reveals two values for the post-meal and pre-bed glucose values:

An A1c test result of 6.5-6.99% was correlated with an average post-meal blood glucose of 139 mg/dl, and an A1c of 7.0-7.45% with an average post-meal reading of 152 mg/dl (unfortunately I can’t tell from the abstract how long after meals these numbers were taken). 

An A1c test result of 6.5-6.99% was associated with an average pre-bed blood glucose of 153 mg/dl, and an A1c of 7.0-7.49% represented an average pre-bed value of 177 mg/dl.

More information on the study is here.

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Spare a Rose, Save a Child: Dedicate this Valentine’s Day to Helping a Kid With Diabetes Survive

Life with diabetes is challenging under any circumstance, but imagine what it would be like if you didn’t have access to syringes, or any test strips, or, for that matter, insulin. It might sound like a rhetorical question, since we all know the answer — at best, you’d develop serious complications, and at worst, you’d die — but that situation is a reality for many kids around the world. (According to Fran Kaufman, MD, diabetes advocate extraordinaire, the death rate for kids with Type 1 in Haiti reaches an astounding 80 percent in the first year after diagnosis.) That’s why a bunch of diabetes advocates have joined together to create the Spare a Rose, Save a Child campaign (for the 2nd year in a row!) to try to channel some of our collective Valentine’s Day love into helping kids who need it the most. 

The basic idea: instead of buying your sweetheart a full bouquet of flowers, you donate the price of one rose (or several, if you’re up for it!) to the International Diabetes Federation’s Life for a Child program. They take that money and use it to pay for insulin, blood glucose testing supplies, diabetes education and clinical care for children in need.

A single rose ($5) can help support a child for a month.

As I write, the campaign is up to more than $14,000 $19,000 (!!) — a truly astounding achievement for such a grassroots initiative. We’re trying to reach at least $20,000. Will you help make this Valentine’s Day make a difference?

More information about the initiative at SpareARose. And you can read another account of why this is important (from blogger Melissa Lee) here.

Please tweet, retweet, Facebook, email, and whatever else you can do to spread the word — and happy Valentine’s day to you all!

If you need any more convincing that this is a big deal, check out this (heart-breaking) trailer for the Life for a Child documentary, “In the Hearts of Africa”:

YouTube Preview Image

 

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