Screwy A1C? Maybe its Your Kidneys...

You've got an appointment with your GP or Endocrinologist coming up and they set you up for a Hemoglobin A1C test. You get it done and on the big day it is higher than you expected. Annoyed, you start thinking of how in the world was it so high when your finger sticks seemed decent or your Continuous Glucose Monitor (CGM) data looked pretty good. If you are like me, we start thinking of how we're going to explain this. Before the appointment starts you feel like your already on defense.

To begin with, let's review what an A1C actually is. According to the CDC, it is a blood test that measures your average blood glucose over the last three months. Specifically,

"When sugar enters your bloodstream, it attaches to hemoglobin, a protein in your red blood cells. Everybody has some sugar attached to their hemoglobin, but people with higher blood sugar levels have more. The A1C test measures the percentage of your red blood cells that have sugar-coated hemoglobin."

So what does this have to do with kidneys? First, if you have Diabetes there is a 1 in 3 chance that you have Chronic Kidney Disease (CKD is a complication of diabetes more accurately called Diabetic Nephropathy). Second, if you have CKD you could also have anemia. If your kidneys are not working well, they may not be making the red blood cells your body needs. The American Kidney Fund does a great job explaining the details of anemia. If your doctor hasn't told you that you are anemic, a quick look at any of your hemoglobin tests will indicate that if the numbers are on the low end. Even if you don't have CKD, you still could have anemia. One study of 200 patients found that 22% had anemia, and of those 41% had normal kidney function and in 27% the cause could not be determined.

But what does this have to do with your A1C? Studies show that anemia has an impact on A1C, and one study cautioned that anemia should be fixed before A1C results are used to guide diabetes treatment decisions. That study has links to other published studies reinforcing the point.

So as a patient, how do you explain this to your doctor when they inevitably say something like "your A1C is too high" or "you need to do better at controlling your diabetes." Yeah--that annoys me, too and if you're going to hunt bear, bring the big guns. Last month, I had a first appointment with a new GP and knew this conversation was coming. What I did was to do a little homework beforehand.

First, I got the results of my most recent A1C, hemoglobin (HGB) and red blood cell (RBC) tests. On April 30, 2021 my A1C was 8.6%. Ugh! My hemoglobin on June 16, 2021 was 9.7 (normal range is 12-17 g/dL) and the RBC was 3.13 (normal is 4.2 to 5.4 M/cmm).

Next, being a Dexcom CGM user I went into their Clarity online system and ran a custom report. I configured it to start on April 30 and going back 90 days so that the CGM data would match the same period the A1C was supposed to measure. I printed it out to take to the appointment.

One thing about CGM reports: I've found that a lot of my doctors are impressed with the technology and once they understand it they find it is a useful tool. A lot of specialists don't have the time to learn about it and that is where we can be our own best advocates. More than once I've carried a copy of the summary page when I thought glycemic control might be part of our conversation. By and large when I show it to them, explain how I use it to optimize control of my diabetes it helps reassure them that I am an informed partner in achieving the best possible outcomes we can achieve by working as a team.

I also printed out a couple of the articles listed above to give to the doctor. First to add some credibility to what I'm saying I wanted to send a signal that I'm relying on vetted, peer-reviewed information--not some Facebook charlatan. Second, with the way doctors have jammed schedules and also want to stay informed, I was trying to support him with both challenges.

When appointment day arrived, one of the first things the doctor said was "you need to get your A1C down." I replied, "Well doctor, I have CKD and anemia. That skews the A1C higher than what my Continuous Glucose Monitor data shows. The A1C is just one data point, but the CGM takes a measurement every 5 minutes which provides 25,920 glucose reading over the same 90 days. While my lab A1C was 8.6%, the equivalent A1C based on CGM data was 7.6%"

I didn't bother explaining the virtues of Time In Range (the emerging gold standard of glycemic control) or standard deviation or other statistics. Our time together is limited and my role is the patient getting care and not an educator. But in the end, I made my case, got the care I needed (for the most part) and hopefully impressed my doctor with the impression that I was an informed partner.

I hope this is helpful and that you don't need to actually need to use this.

Kindest regards,

-Tom

Advocating for Affordable Insulin: Thinking Outside The Box

 

There is no issue of greater concern for people with Type 1 Diabetes than the rising cost of insulin. From Washington to your local pharmacy, people are furious, frustrated and scared. While some turn to social media to vent their anger and advocate for change, others look to Congress for a solution. The former might make folks feel like they are doing something (and feel better in the process). Traditional media (newspapers and TV news) have also covered the issue of the exorbitant cost of insulin. In addition, the President and some in Congress have said that out of control drug pricing is a problem that needs to be solved, but beside posturing, there has not been any substantive legislation introduced that could realistically be enacted.

 

In other words, there is a lot of 'buzz' about the issue. Other than a lawsuit alleging price fixing and collusion between the three major insulin manufacturers, there aren't any prospects of a solution anywhere on the horizon.

 

So what is the solution?

 

Each of the three major insulin manufacturers (Eli Lilly, Sanofi and Novo Nordisk) are publicly traded corporations. They view their primary obligation to provide value to their shareholders. Love it or hate it, that is why they exist.

 

Since they are focused on pleasing their shareholders, we could look at reaching equity owners as to get these corporations to manage insulin pricing differently. Sanofi currently has 2.584 billion shares trading at $49.21 each. Novo has 1.96 billion shares trading at $40.60 each. Lilly is priced at $80.19 per share, and with 1.103 billion shares outstanding has the lowest market cap of the three at $88,500,000,000. Unless you are Warren Buffet or Bill Gates and you put all your money into just one of these, you don't have the financial horsepower to bend them to your will. Scratch that idea.

 

Who sets insulin prices in the first place? Most likely it is a team of financial and managerial accountants who consider cost data, sales forecasts and guidance from senior management among other considerations. After crunching the numbers they arrive at a figure, it is approved by the executive(s) empowered with that authority, and then put into place. As conditions change, that price will be evaluated and the process repeats. But if they arbitrarily drop the price, revenue will fall and the bean counters will have to make it up somewhere else in order to (as always) keep investors satisfied.

 

Maybe appealing to the Chairman or CEO would work, right? If we leaned on him hard enough, couldn’t he just say 'the hell with it - we need to make insulin more affordable, so we are dropping the price to $X.XX per vial.' Well, no - for a couple of reasons. Like the bean counters, they are responsible for keeping the shareholders happy by maintaining optimal profitability. Secondly, making one group of customers happy would probably infuriate other customers. Dropping the cost for patients with diabetes would mean raising prices on products used by other patients. Placate the second group and the process is repeated ad nauseum. One thing Chairmen/CEOs avoid like the plague is unnecessary turmoil. Annoying customers and investors isn’t part of their job description. Which of us goes out of our way to jeopardize our livelihood - especially for a constituency that will likely be unsatisfied and won't do anything for us? Finally, they get paid to take heat when it comes, and part of that is weathering a storm – like insulin prices.

 

So who can get things done? The Board of Directors. They set the strategic direction of the corporation. As long as shareholders are generally happy, directors are empowered to do almost anything they want. By and large they have pretty wide latitude. Normally a Board wouldn't get so far into the weeds as setting prices for a product, but if there is enough pressure on them to get involved, they just might. Also, they aren’t the public face of the corporation. Nobody raises hell with them, so what a Chairman/CEO might brush off as part of their job might be enough to get a Director to ask hard questions. The kind of questions that a Chairman/CEO and his subordinates would have to answer.

 

Here would be my plan of attack:

 

I’d go after the Directors of Lilly. Sanofi and Novo Nordisk are multinational corporations that are headquartered overseas. They’d be less vulnerable to public heat in America than Lilly would be.

 

I’d look at their Board of Directors and their biographies. Which would be most likely influenced by the stories of patients who could not afford insulin? Maybe those with a healthcare background – particularly in patient care?

 

I’d look at the members of the Public Policy and Compliance Committee. Part of their charter is to “…review, identify and when appropriate bring to the attention of the board political, social and legal trends and issues, and compliance and quality matters that may have an impact on the business operations, financial performance or public image of the company.”

 

I’d get the contact information for each of the directors I was going to contact. Google is your friend.

 

I’d send each of them a one page letter. They are more personal. They are not as easily dismissed as an email. They are not missed like a tweet (assuming some of them are on Twitter).

 

Here is what I would say:

• I’d tell my story.
• I’d identify myself as a customer.
• I’d tell them my very life depends on their product.
• I’d tell them how much I pay for their product, on top of my insurance premiums and co-pay.
• I’d tell them what I cannot do for my family or myself because of how expensive their medicine is. I’d ask them how they would deal with these challenges if they were in my shoes.
• I’d tell them what I think is a reasonable profit for insulin.
• I’d ask them to contact me and tell me how they will make insulin affordable, when they will do it, and what they’ll do to keep it that way.

 

Most of all, I’d share that with other people with diabetes. I’d tell them what I did, who I contacted, what I said and I’d encourage them to do the same.

 

Simple Tips for Coping With Diabetes

"How do you eat a whale? One bite at a time."

That is what a wise old Army First Sergeant told me once when we were getting hit with a hundred tasks at once, each more important than the last. In the 12,186,720 minutes that I've had Type 1 Diabetes, that advice has come to mind more than once.

We know that dealing with this is a 24/7/365 proposition. Even when we are asleep, it can still wake us up and demand our attention. Most of the time, we are on our own. If we get an hour to talk diabetes with a doctor every 3 months, that amounts to 0.046% of each year. If we are lucky, we get as much training in managing diabetes as we would if we took a CPR class. In other words, we get to mange and be held accountable (by doctors, family and friends) for mechanically managing a complex biochemical process with potentially deadly drugs using inexact tools and relying on minimal training. Oh yeah - there is no end in sight, and no reward for winning.

It's no wonder that this gets us stressed out and overwhelmed from time to time. We all have days where everything works perfectly. More likely that insulin bolus is as effective as a shot of water, the carb data we use came from a practical joker, or our blood glucose meter spits out numbers that came from a lottery number generator. In other words, we do our part right but it doesn't work. All of those failures - one after the other - can destroy our confidence (a critical thing we need when trying to stay on top of a potentially deadly disease).

I've been playing the D game for 23 years. I've had ups and downs, and more than once I've wanted to throw in the towel. But we don't have that luxury. Like another friend said, "you don't have to like it, you just have to deal with it." Here's how I try to keep things on an even keel and to keep a sense of calm in the process.

• Don't beat yourself up over the past. Learn from it if you can, but if your carb count was off, your bolus didn't work or that correction didn't budge your BG one iota - forget it. You can't change it - it's over. If you had a 12 hour run between 110 and 115, celebrate. Use that to leverage your confidence. Learn from the bad, celebrate the good and move on.

• Focus on today. You know what you need to do: do it right. Test before and after meals, before driving and when you feel off. Use the best available data for carb counts. Get the insulin going in a good location and on time. Every time you do something D related, do the best you can with the use of all the experience and judgement that you've accumulated in your D journey. I talk to myself silently as if I were explaining what I was doing and why to my endocrinologist or to somebody I was trying to teach. Today is the focus. If I give it my best effort, that is the best I can do. When my A1C results come back, I'll know that every day I gave it 100% and I'll be pleased with that, regardless of the number.

• Don't sweat tomorrow. If you think about how many carb counts, finger sticks, boluses and corrections that you will have to do in the next 5, 10 or 20 years (or until there is a cure) it will overwhelm you. When I was a little kid, I watched my mom take a thyroid pill. I asked her how long she would have to do that and when she said "for the rest of my life" I was freaked out. I couldn't imagine that. The same goes with my own diabetes. One time I counted all the shots, fingersticks, etc. that I'd done. While the numbers were impressive and I thought I was one hell of a guy for having done all of that, it also made me think of what they might be a few years from now. Not good. Instead of worrying about that, I figure if I work hard today, tomorrow will take care of itself. 

• Help each other. Somewhere, somebody is out there who has been where you are now. Reach out - you'll be surprised how many people like you are willing to help. Likewise, you have wisdom that might help others. (That is why I write some of these things.) Twitter, Facebook and some online communities are great places to find those folks. There may be groups in your community as well. Keep your eyes and ears open - help and support might be just around the corner.

In a nutshell, diabetes can play hell with you psychologically, but it doesn't have to be that way. Do your best now and don't think about yesterday or tomorrow. Easy to say, but hard to do. But just like trying your best today with managing your diabetes, handling the mental part works the same way. Do your best, forgive yourself when needed and keep working at it.

You can do this!