Glucose Meter Accuracy and the FDA

A topic that many diabetic bloggers have weighed in on recently is the fact that the FDA is planning a public discussion of "the clinical accuracy requirements of blood glucose meters...." The hope among many diabetics is that the FDA will decide to require greater accuracy from these devices. Currently, they are allowed to be within plus or minus 20 percent of a clinical blood test.

If you have an opinion, you have until April 10 to tell the FDA here.

Here are some of my thoughts on the issue.
The FDA, in its notice of this public meeting, explains:

Blood glucose meters are being used in clinical settings and at home in ways that are not within the intended use of the devices as evaluated by FDA. For example, glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been cleared for this use.

Excuse me, but that just doesn't cut it. The American Association of Clinical Endocrinologists (AACE) recommends that diabetics have a target A1c of 6.5, with a target blood glucose level of less than 110.
If the FDA rationalization above is relevant, then we can ignore the target blood glucose, because we don't have anything to test blood glucose with, not if we're trying to adhere to these guidelines. According to the FDA, it is not the intended use of our blood glucose meters to keep our blood sugars that tightly controlled.
Of course, if these meters aren't intended for this purpose, then we are missing a key piece in the diabetes management system.
Reading any reference on diabetes management, consulting with any manual on how to use an insulin pump, an insulin pen, or a CGM will show repeatedly that we require accurate meters to do what doctors, CDEs, and medical device manufacturers are telling us to do.
Whether or not the FDA and the meter industry want to concede the point, these meters are for "tight glycemic control."

To determine how accurate the meters should be, I suggest they look at how accurate the dosing of insulin is.
Look at the lines on the side of a 1/3 cc insulin syringe, or the increments on an insulin pen. Consider the insulin pumps with increments of 0.025 units of insulin.
Blood glucose meters should approach this level of accuracy, or something is out of whack.
If it's OK for my blood sugar reading to be 30 points off, why should my pump be able to deliver increments of less than half a unit?

Indeed, why am I not still just peeing on a color-changing strip and taking one shot of long-acting insulin a day?

To see some other blogs on this topic:

Scott's Blog - Tell the FDA +/- 20% Is Not "Good Enough" Today

Diabetesaliciousness(tm) - Meters = Diabetes GPS System!

Six Until Me - Accuracy in Glucose Meters

Your Diabetes May Vary - What is Accuracy?

Phoenix Tour de Cure 2010

Here I am at the Phoenix Tour de Cure last Saturday. I know how badly the outfit clashes, but I wanted to represent both the Red Riders (with the jersey) and Triabetes (with the shorts).
It was a beautiful, sunny day on a course on the outskirts of Phoenix running up past Anthem and New River. I took it easy and stopped at all five aid stations and one Burger King on the 64 mile course. No I didn't go in for a burger, I just figured it would be quicker to make a pit stop there than to wait in line for a port-a-john at an aid station, and I was right.
My new 2009 Kestrel Evoke performed great. I had never ridden it before, never used the integrated brakes/shifters before, but it all worked fine. I figured out the shifters within the first thirty miles, none the worse for the wear.
I had worried that my Kestrel Evoke would seem tediously slow compared to the Kestrel Airfoil I had been riding last year. (This was my first ride since November 2009.) The Airfoil costs about four times as much as the Evoke. But it seemed great to me. I was surprised how easy it was to crank it up over 20 mph on a flat stretch.
I look forward to riding it again tomorrow.

My New Ride

As you probably know, I'll be riding in the Phoenix Tour de Cure on March 13. (That's my birthday. It's not too late to donate if you're wondering what to get me.) The big question leading up to this ride has been what bike I would be on. The Kestrel Airfoil I rode last year went back to Triabetes, where you can buy it now if you want a bargain on a fantastic bike. Since I gave that one up, I have not been on another bike.
But on Saturday, I went to TriFest with my brother, Jon, and met up with Peter Nerothin and Kevin Burgess, Triabetes Teammates who had set up the Triabetes tent there. I wanted to help out Triabetes a little, but mostly, I wanted to see what was shaking at TriFest, and possibly get a deal on a bike.
Well, I got a great deal on a 2009 Kestrel Evoke. It felt good during the fitting, but I haven't had a chance to ride it outside yet. The metric century Tour de Cure may be my first ride on that bike. I know that's not the wisest thing to do, but it's about par for me. That just seems to be the way I do things.

It should be a blast, riding with hundreds of Red Riders and people concerned about diabetes. This is actually a great time and place for a shakedown cruise. There will be all kinds of support for me and my bike out there, and the forecast is for beautiful weather.

2000 Miles to Chicago

So it's about 2000 miles from Chandler, AZ to Harpo Studios in Chicago, IL, where Oprah and Dr. Oz film their TV shows. If I were to bike the distance, I suppose I could do around 50 miles per day for 40 days. It would be possible to do it faster.
Running, I wouldn't want to schedule myself for more than 20 miles per day, which would mean it would take at least 100 days.
I'm trying to think about how I could fit it into my life to do an epic ride or run out there to tell O&O they are full of crap.
At this point, this is just a crazy idea that I haven't really thought through. Don't count on it happening. It's just what I would like to do, if I didn't have any responsibilities. It's a dream.

In my dream, I would set out for Chicago and get more and more publicity on the way until Dr. Oz started to think, "Gee, maybe I should set the record straight on some of the absolute hooey I have been repeating over and over in print and on television."
And of course, Oprah might ask herself if Dr. Oz is really as smart as she thought he was.
Then by the time I got there, we would have nothing left we disagreed about, and I would just go home.

Carlsbad Marathon etc.

I haven't done much of anything for almost two weeks. This seems like a good time to catch up on blogging about things that happened recently.

 

Starting Friday I will be on a road trip vacation to Northern California to visit my favorite daughter and the world's cutest grandson. I may be even more detached from this blog than usual.

I realize that there can be no "regular readers" of a blog that doesn't have writing regularly updating it, so I really do want to keep up my blogging.

On January 24th, I did the Carlsbad Marathon as part of the huge Glucomotive presence at that event. It was another fantastic experience for me, as every Glucomotive event I've done has been.

I drove out to the coast with my brother Jon, and the first thing we got to do Friday night when we called and asked how we could help, was to go pick up Kerry Kuck from where he was staying and bring him to the first gathering of the weekend.

Kerry is a courageous and amazing blind marathoner with type 1 diabetes.

  

That was just the first of many things from that weekend I will remember forever. Saturday, we had breakfast on the beach with many of the PWDs and diabetic supporters in town for the race.

 

Sunday I ran the Carlsbad marathon, my 50th lifetime marathon, and crossed the finish line with Peter Nerothin, type 1 diabetic, Ironman, ultramarathoner, founder of InsulInDependence, Triabetes, and Glucomotive, and John Moore, type 1 diabetic, Ironman, marathoner, ultramarathoner, and Amy Flores, a type 1 diabetic doing her first half marathon.

It was a special moment to share with Peter and John, friends of mine for a while, but being there with Amy made it just magical, she was so excited about the new directions her life is going.
Then following the race we went to a barbecue hosted by type 1 diabetic surf hero Matt Besley and his family, to celebrate our accomplishments and watch a little playoffs football.

 

The weekend was just packed with fun. It was hard to finally decide that it was over and Jon and I had to start back.

I'm looking forward to the next adventure.

Oh, yeah. I already had the next adventure at the Desert Classic Marathon on January 30th.

But that's another blog post...

Pay No Attention To That Man On Oprah

Let me put these two disclaimers right up front.

First: I am not a doctor. I have no other medical background than being a diabetic for close to 36 years, and keeping my eyes open for information that might help me survive. I read the occasional article on the subject of diabetes.
If I was going to do a show about diabetes, I would have to bring in experts, like maybe an endocrinologist.
I am not an egotistical, know-it-all cardiologist who can glibly and confidently talk down to a studio audience and millions of home viewers.

Second: I didn't watch the Oprah Diabetes Show, America's Silent Killer. I only learned a little about it from friends and went to her web site to try to get a transcript. She is selling transcripts for $20. I didn't think it was right that I should pay $20 to her just because my friends were so incensed by her show that I wanted to see what they were so upset about.
So I did the next best thing and read the article on her web site. I figure this is fair, since it would be much easier to make this article accurate than a verbatim transcript of the show. My statements about the show are based on the articles about the show and the videos on the web.

So, somehow Dr. Oz did this whole show focusing on type 2 diabetes without mentioning insulin resistance. Bob Greene talks about it, and seems to understand it, but not Dr. Oz.
Dr. Oz also did not mention carbohydrates except to say that sugars are also referred to as simple carbohydrates. Neither did he mention the glycemic index.
There was no endocrinologist on this show about diabetes.
I know that if you, like me, have been discussing diabetes with other diabetics you find this hard to believe. How did they do a whole show? What did they talk about? How did they avoid subjects like these?

The American Diabetes Association lists the 10 most prevalent diabetes myths. The Oprah show actively reinforced four out of ten.
I will edit and summarize:

Myth: If you are overweight or obese, you will eventually develop type 2 diabetes.
Fact: Most overweight people never develop type 2 diabetes, and many people with type 2 diabetes are at a normal weight or only moderately overweight.

Myth: Eating too much sugar causes diabetes.
Fact: Type 1 diabetes is caused by genetics and unknown factors that trigger the onset of the disease; type 2 diabetes is caused by genetics and lifestyle factors.

Myth: People with diabetes can't eat sweets or chocolate.
Fact: They are no more “off limits” to people with diabetes than they are to people without diabetes.

Myth: If you have type 2 diabetes and your doctor says you need to start using insulin, it means you’re failing to take care of your diabetes properly.
Fact: Using insulin to get blood glucose levels to a healthy level is a good thing, not a bad one.

Concerning the other six myths, except for the first one, Dr. Oz did not address them. The first Myth on the ADA web site is:

Myth: Diabetes is not that serious of a disease.

The Oprah show seemed to be concentrated on sensationalizing the complications of diabetes to the extent that it seems it spent more time on that than on prevention, diagnosis, and treatment. They called it America's Silent Killer, after all.

I went through the article counting up things I knew to be wrong. I marked off 25. For example:

"Most diabetes is preventable," he says. "It is treatable, even reversible."

No, diabetes is treatable but not "reversible."
TYPE 2* diabetics can often control their blood sugar through diet and exercise. But if they discontinue the regimen of diet and exercise to control the diabetes, the high blood sugars, and the complications, will return.
The diabetes is not "reversed." They are not cured. They have simply found a way to control their diabetes.
They have found an effective treatment. They have reversed the symptoms of diabetes.
If they discontinue the treatment, the symptoms of diabetes return. This is the difference between diabetics and non-diabetics.
Note that the difference is not obesity. The difference between a diabetic and a non-diabetic is that behaviors that don't cause high blood sugar in a non-diabetic do cause high blood sugar in a diabetic.

*Why doesn't he say TYPE 2 when referring to type 2 diabetes and diabetes when referring to all diabetes?

"There are two types of diabetes: type 1 and type 2."

This very article contains reference to gestational diabetes, which is not type 1 or type 2.
In addition, there are many people with diabetes who are not easily put into either category of type 1 or type 2 diabetes.

Type 1 diabetes, formerly known as juvenile diabetes, affects 10 percent of Americans diagnosed with diabetes. "[You're] not making enough insulin."

Not making enough? Most type 1 diabetics make absolutely no insulin. Before the full onset of the disease, there may be a "honeymoon" period during which a type 1 diabetic produces a trace of insulin.
Some people make very little insulin, and that is one way someone might not fit into either category of type 1 or type 2.

"That's generally from genetic reasons because your pancreas just doesn't work correctly,"

Generally from genetic reasons?
The pancreas just doesn't work correctly?
Is this wrong, or just dumb?
Let's just say it. I don't think Oprah's viewers are too dumb to understand. Does Dr. Oz?
Type 1 diabetes is usually caused by a person's immune system malfunctioning and killing off the insulin-producing cells in the pancreas.

Type 2 develops from lifestyle issues.

There is always a genetic component in type 2 diabetes, just as in type 1. It is not just caused by lifestyle choices.
Remember the ADA says, "Most overweight people never develop type 2 diabetes, and many people with type 2 diabetes are at a normal weight or only moderately overweight."

"[Patients] have a lot of belly fat and the like, and they have enough insulin," he says. "But it's not listening anymore...."

No, insulin resistance, however it is caused, is not the only cause of type 2 diabetes. Many type 2 diabetics are not producing enough insulin. In fact, many type 2 medications promote the production of insulin for this very reason.

Diabetes, particularly type 2, is the fastest-growing disease in history because of one thing—sugar.

Obesity is a problem, and the rise in type 2 diabetes is related to the rise in obesity. But sugar is not nearly the sole cause of all of these problems. That's ridiculous.

At this point I have to break off quoting Dr. Oz. He is wrong on generalities. He is wrong on specifics.
He is so full of crap on things I actually know something about, that I don't believe him on anything I don't know about.

The whole Oprah diabetes show was a giant, steaming pile of misinformation and mythology, stereotypes and sensationalism.

Oddly enough, Dr. Ian Smith and Bob Greene were apparently able to discuss diabetes sensibly, without any falsehoods, stereotypes, or myths, to make it clear when they were talking about obesity, type 2 diabetes, or diabetes in general.
So it can be done, even on Oprah.

UPDATE: It's been suggested, and it seems like a good idea, that all of the blogs on this topic include a link to comment to Oprah. http://www.oprah.com/ownshow/plug_form.html?plug_id=220

Let's Roll

One of the problems with being slow to blog about what happens in your life is the fact that other things come along.
I have been intending to write about the Carlsbad Marathon weekend for two weeks now. I did start a blog post, but didn't get very far. But something else happened Wednesday that demands my attention today.

Jesse Alswager passed away at the age of thirteen, after 10 years of fighting type 1 diabetes. When I say fighting, I don't just mean like all of us type 1 diabetics fight, with finger stick blood tests, injections or infusion sets, CGMs, counting carbs, thinking through the metabolic effects of every meal, every bit of physical activity, everything....
What I mean is that he was fighting like he was in a war.
When Jesse was diagnosed at the age of three, his mother, Michelle Alswager, declared war on the disease, and she took her son into battle.
Jesse raised thousands of dollars for the cure, a cure he will never enjoy. Michelle, as a member of the board of directors for several diabetes foundations and eventually an executive at the Juvenile Diabetes Research Foundation was involved in raising millions.
Jesse met governors, Congress members, First Lady Bush. Politicians loved to be photographed with him and talk about him.
I never met Jesse. I wish I had the chance to thank him. He did a lot for me.

One of the things that Michelle Alswager did to raise funds for the cure was the JDRF Ride for the Cure. She met type 1 diabetic athletes, and learned how they were overcoming the challenges of the disease.
Michelle became a cyclist, then a triathlete, then an Ironman. Some time in 2006 she came up with the idea of a type 1 diabetic triathlon team, and a documentary about how they could train for and complete an Ironman.
That was how Triabetes began.
Triabetes has had a profound effect on my life, and I know that it has touched many more diabetics out there.
When I first heard, it knocked the wind out of me. It was more than a little discouraging personally, to learn that the inspiration for Triabetes had died. The inspiration had died. Yeah, that's how I felt.
And it was heart-breaking to think that Michelle Alswager, who had worked to spread hope to people like her son, people like me, suffering from type 1 diabetes, had lost her son.
For several hours this was a hope-crushing thought for me.
But now I've decided that it's part of this war. I've been around for the war, but mostly on the sidelines. I have not yet begun to fight.
I have to take to the battlefield now.

This has been true for the past couple of years, but I would like you to take notice of it now. There is almost always a link on the left hand side of my blog to some diabetes-related charity. Right now it is the Tour de Cure for the American Diabetes Association, but that will change. There will always be something.
If you read my blog, please consider, every few weeks, clicking one of the links and making a donation. This request is my first tentative step.
Tonight I'll be swimming, thinking of Jesse. Tomorrow I'll run. In March, I'll ride for the ADA. Later this year I'll ride for the JDRF.
Next year I'll complete an Ironman.

Anne is in contact with the Alswager family and will post information about memorial services and how to express condolences on her blog.

UPDATE: There is a memorial site for Jesse at: http://www.caringbridge.org/visit/jessealswager