November 27, 2017

I'm Testing the FreeStyle Libre Flash Glucose Monitoring System

Last week I received a FreeStyle Libre Flash Glucose Monitoring System #FreeStyleLibre from Abbott to try out. I have been very interested in this product for quite a while as if it does what is claimed for it, it could be a huge help to people who are trying to learn how food affects their blood sugar. So today, having gotten through most of the Thanksgiving goodies, (which I did not want to track with a glucose monitor, thank you!) I got up my courage and inserted the sensor into the back of my arm. I had read all the instructions a few times and am hoping I did it correctly.
The sensor comes with a spring loaded applicator that shoots it into your arm. It stung for about half a minute, as the sensor samples blood through a small needle. A bit of blood appeared on the outside of the sensor when I was done, which I wasn't sure about, so I called the 800 support number the company provides and spoke with a customer support person who assured me this was normal unless it hurt and/or there was "an excessive amount of blood." She was unable to define "excessive" but it seems like the thing isn't bleeding any more.
I then waved a little phone-looking device over the sensor and it beeped and told me it was started and to come back in 12 hours. It takes 12 hours for the sensor to be able to report accurate readings. I will be very interested to see what the results look like.
The booklet that comes with the Freestyle Libre System states that the accuracy is plus or minus 15-30%, which is broad enough to make you wonder. But this thing is measuring interstitial fluid, not the fingertip blood that can be a bit more accurate. I am mostly interested in the graphs it will produce to see where exactly peaks and valleys occur, and to learn what is happening late at night when I sleep, as I see higher fasting blood sugars than I like this past year, no matter what I eat. I don't know if it is dawn phenomenon or a raised fasting blood sugar. This should help, even if the actual readings don't match a good meter.
The device which analzyes the sensor's data and graphs it also works as a blood sugar meter with FreeStyle Precision Neo test strips, which do not come with the system. So I will be checking against my trusty Ultra Mini and my old FreeStyle Lite meter which I still have some strips for. The FreeStyleLite meter usually reads about 10 mg/dl below the Mini.

Here's a picture of the sensor, installed.
I'll update my progress as it happens. There is an active discussion going on at my Facebook page. You can join in at https://www.facebook.com/bloodsugar101. Commenting is so flakey on the blog and the trolling it was receiving so ugly that I have had to turn it off.

After 24 Hours


So here are my impressions after a full day of wearing the #FreeStyleLibreglucose monitoring system that Abbott Global Solutions gave me. I love it. It has its flaws, yes, but after almost 20 years of testing my blood sugar with strips, it is downright amazing to be able to check my blood sugar any time I want to and to finally be able to see what has been happening during all those many hours when I haven't been able to test.

The accuracy I'm seeing is close enough that I can definitely see where it could be a huge help in getting better control for anyone who isn't getting very flat sugars eating an extremely low carb ketogenic diet--which is probably 99% of all people with diabetes in the world. I have 3 meters, none of which, it turns out, agree with the others, so this is just another meter that doesn't agree, but it is falling in the same general range as my other three. Sometimes it is higher, sometimes lower, but the magnitude is within 10 mg/dl and often closer. I'm not quibbling about whether a high of 164 mg/dl is really 155 mg/dl. It isn't 135, and that is what I'm concerned about.
At this level of accuracy, I'm seeing very clearly how long my highs last and how they effect the low I see at the next meal. Some findings are a bit surprising. For example, the pizza slice I ate for lunch wasn't nearly as hard on my blood sugar as a slim slice of Thanksgiving pie I had for dinner later. The carbs were probably the same, but the high from the pie lingered forever. So what I learned is that as the day goes on, my tolerance for carbs seems to drop significantly. This is good to know, and since I usually eat my big meal at lunch, not a big problem.
I'm eating a lot of stuff that will push my blood sugar up, while I have this device, in order to get a good idea of exactly how my blood sugar response is performing now. If I wore one of these for 10 days every month, once I had figured things out I would probably be more likely NOT to eat things that might make for a long, visible spike.
I'm also seeing some things that I didn't know were going on at times when it wouldn't have occurred to me to test, including a several hours of what was for me a low blood sugar after eating a breakfast that met my target. This wasn't a hypo, but it wasn't a number I had ever seen on a meter for a long time. With my limited access to strips I can't test very often, and mostly just look for highs. This explained the 85 mg/dl reading I got when the doctor sent me to the lab which I had found baffling as my fbgs are usually 108 mg/dl or higher.
I'm also thinking that with this device showing me minute by minute readings I will, at long last, be able to get the repaglinide I take to work properly. I never felt safe using it with only the 50 strips a month I get from my insurance. Now I will be able to see exactly when it kicks in and how long it lasts. They tell you not to rely on it for dosing insulin, but so far it is pretty solid on when blood sugar is rising, falling or stabilizing. With repaglinide, which can cause severe hypos, any downward motion at a reading anywhere near 80 would be a warning that would get me testing with a meter.
As far as comfort goes, I got used to it after the first night, and am now to where I don't even notice it. I was able to sleep rolling over on that arm with no issues last night. I even remembered to test when I woke up at 2 am so that I didn't lose any readings.
The reader works great through my clothing and ski jacket. You can turn off all noises or set it to vibrate, so you can use it in public without anyone noticing it. Ditto late at night. It is also very easy to set alarms for 1 and 2 hours after eating and you can enter in the grams you ate when you enter a food.
There are some negatives and I will list them here:
1. The reader doesn't come with a case so for a woman like me who carries everything in a purse and wants to carry the reader everywhere, it's possible the reader could get scratched up.
2. The reader screen is not hard like cellphone screens but soft--which is understandable for the price. But you sometimes have to really press on it for it to know you have made a selection.
3. Though it keeps a log of your entries, only the last 3 show up on the screen at once and paging through is a pain since you may make dozens of readings a day. You can't see the details of how many grams were in a meal unless you find the original entry for the meal. With how often I am scanning the meter, this means I can't find what I ate without a lot of slogging.
4. The blood sugar graph is tiny and the scale goes up to 350, so for those of us in good control, it's hard to know exactly how large an excursion is unless we test during it. This is mainly a problem at night time. I saw several drops graphed during the night, but can't tell from the graph how steep they were. I.e. were they to 85, 90, or 100 mg/dl since I woke up again around 108.
Supposedly you can upload your information to a web site so you can see your data better and share it with your doctor. I tried it and couldn't get it to work, but the company rep explained it won't be live until Friday. I will report on how useful it is when I can get it working.
I am still waiting to hear what the price will be. Supposedly someone will get back to me. If they do, I will update the info in a comment on this thread. They did tell me that the Freestyle Libre system will be available for retail customers to purchase next Monday. However, you will need a prescription.
If this is priced like the Canadian version, which would be $70/sensor, it would be well worth the money for anyone who isn't currently getting an A1c of 5.4% or better. Look at it this way. You are going to pay deductibles of $500 or more for a single MRI caused by the damage you end up with from high blood sugars. I'd rather spend the money learning what I need to know to avoid them.
I am liking this thing so much, right now, that if the second sensor they sent me performs at the same degree of accuracy, I'm thinking that if I can get my doctor to give me the needed prescriptions, I will use one sensor each month to keep myself motivated and in range. My insurer won't be covering me for any device with that 5.7% A1c, and it will be a struggle to get the doctor to write the prescriptions, as he thinks it is hilarious that I am not happy with that 5.7% A1c. But seeing those 160s and 170s on the FreeStyle Libre (and strips) and the many night hours I am spending at 110-113 (no dawn phenomenon, it turns out) is motivating me to do better. FWIW, the average blood sugar I am seeing on the FreeStyle Libre so far is 117 which matches my 5.7% A1c.

Two Days In 

I did see more discrepencies between the meter and the FreeStyle Libre system when I tested some repaglinide (which can cause lows) last night and ended up in the 70s. But I'm thinking it may also have been a bad strip or meter--because my two minis turned out not to agree. Basically, the whole meter thing is BS half the time, too. 

But still, all very useful, as I could see how long the effect of the repaglinide lasted, and when it kicked in, which were not when I expected, and explained why I was having so much trouble making it work. I have been moved to a generic instead of the brand name I used to use, and it definitely is NOT the same in terms of how long it takes to become active. 

I also, for the very first time, caught a low turning into a rebound high at night. I woke up saw a 72 on my FreeStyle Libre system and then about 25 minutes later, I surfaced from sleep and saw 118 mg/dl. I KNEW this was something that happens to me sometimes but never could document it it, and of course doctors told me it couldn't possibly happen. I also knew that when it happens I get a surge of high blood pressure, and a pounding pulse at times, too. The cardiologist insisted this, too, was impossible. So there doctors who told me I was FOS!


Pricing Information from the Company

Many of you have asked me what the price is going to be of the #FreeStyleLibre system. This just came to my email box directly from @abbbottglobal: "The list price for the FreeStyle Libre system is $36 per sensor and $70 for the reader (one time purchase). However, prices may vary depending on the retailer or an individual’s insurance carrier. We are still in negotiations with commercial payers."
Close concerns has reported "Walgreens has the 10-day sensor priced at $43, compared to $53 at CVS; readers are $97 and $85, respectively."
My guess is that Walmart will be cheaper, as is usually the case. Walmart, RiteAid and Kroger are also listed as participating pharmacies on the FreeStyle Libre official website.
This makes this device highly affordable. And just in time for Christmas. Instead of having your relatives give you all those stupid "gifts under $10" which you will stick in a closet and eventually regift, you could ask them to pool together and get you a reader and a couple sensors.
Some of you may wonder why I am suddenly so enthusiastic about a product from Big Pharma, knowing as you do that I am usually so UNenthusiastic about anything Big Pharma that I have been excluded from every single Big Pharma-sponsored diabetes blogger get together ever held. Well, the answer is what I care about is people understanding their blood sugar and learning how to lower it without all those toxic, ineffective drugs doctors prescribe because they are the easiest way to get diabetics out of the office.
This device is mind-bogglingly informative. The only thing missing, sadly, is some hint in the company's manual, that if you see a high you can lower it by cutting back on your carbs. But we can get that message out a lot easier if people are seeing those real time spikes after eating.
So Big Pharma this time has hit a home run and I honor them for it. For the price of a fancy cup of coffee you can get 24 hour real time monitoring of your blood sugar that is good enough to help you make the changes that will drop your blood sugar into the range that will keep you from every developing complications.
You just have to be willing to cut the carbs when you see those long, ugly spikes.
And at this price, it is very possible insurers will cover it, though my guess is, only for people on insulin. The only downside I can see, is that knowing how insurers think, it is possible they will try to force people on insulin to use these instead of the much more expensive Dexcom CGMS which is more accurate and reports continually without scanning and which issues alarms when a low occurs which can keep sleeping people alive. This is NOT a replacement for a Dexcom. It is an upgrade from 25 to 100 strips a month. It's like getting 1000 strips every ten days. And no finger pricks!
BTW, the thing is still completely painless even though I keep rolling over and sleeping on it.

Graphs Show The Kinds of Information the Libre Provides that I Missed when Testing with a Meter


You can read a discussion here on my Facebook Page where I show how tesing at 1 and 2 hours misses very different patterns of response to foods. The graphs are posted, too. 

Facebook Post Showing and Discussing FreeStyle Libre System Graphs








May 8, 2017

Jenny Ruhl Just Published a Brand New Diabetes Book

For those of you who don't read my Facebook page, I wanted to let you know that my brand new diabetes book has finally launched.  This is the first completely new health book I've written since 2012. It's 240 pages long in print and packed full of stuff I didn't have room for in Blood Sugar 101.

It's called Your Diabetes Questions Answered: Practical Solutions That Work and Keep On Working.



This book is a problem solver. It uses an easy-to-read, informal Q&A format to answer over 200 questions of the sort people have been emailing me over the years since I first published Blood Sugar 101.

If you've read Blood Sugar 101, some of this material you'll find here will review what you already know, but quite a bit of what you'll find here is new.

You can download a sample or go to your favorite eBookstore to buy the paperback or eBook versions.

Your Diabetes Questions Answered: Practical Solutions That Work and Keep on Working is now available at these links:

Amazon Paperback

Amazon Kindle

Barnes & Noble Paperback

Nook eBook

Apple, Kobo, and more ...

If you find it helpful, do consider posting a review on the bookstore website where you bought it. That's the best way to raise the visibility of a new book nowadays so that other people who need it can discover it.


April 4, 2016

I'm posting news items on our FaceBook page now

Instead of writing new blog posts, which few had been reading, thanks to the demise of blog reader software, I have been posting newsworthy items on the Blood Sugar 101 Facebook Page, which you can find here:  https://www.facebook.com/bloodsugar101 .

I'm disappointed in the lack of discussion about these items that takes place on Facebook, but that's the way the new world of supposedly "social" media works. The design of social media make it very difficult to conduct any kind of adult conversation. And FB makes it almost impossible to keep discussions going since they scroll off and are immediately replaced by dozens or hundreds of new posts.

But that is apparently what people want and where the eyeballs are. So that's where I'm posting interesting diabetes-related updates for now.

Do stop by and if you have something to add, please add it!



December 2, 2015

A New, Expanded Edition of Blood Sugar 101 Is Coming Very Soon

I am very happy to announce that I just sent the newly revised and expanded second edition of Blood Sugar 101: What They Don't Tell You About Diabetes to the printer.

I hope it will be available for purchase by December 15 in both printed and ebook formats. If all goes well, this means that it will be available at all major online bookstores in time for January 2, the beginning of the Annual Season of Repentance--the time when even the sloppiest of us get serious about diet and health.

The new edition is 38 pages longer than the first one--and this expansion happened after I deleted the recipe section (which is still available online.). So there are actually 43 new pages of text. This new content includes several sections addressing the most common topics, not covered in the old edition, which people have emailed me about over the last 3 years since I made a minor update to the text.

The book is still the same, in terms of what topics it discusses and what strategies it promotes. New research has been cited only where it adds strength to the points being made, but I have worked very hard to keep the book clear and accessible to readers who are looking for simply explained, actionable advice.

The influx of so many new drugs into the market, and the availability of so much new research about the older diabetes drugs has made it necessary to add a second chapter about these drugs, splitting them into Generic and Patented Diabetes drugs. I also discuss Weight Loss Surgery as a cure for diabetes, the Newcastle and Vegan diabetes diets, and have expanded the exercise chapter a bit.

I've also come up with a new cover that is easier to read online since my books are sold almost exclusively via web bookstores.

UPDATE: :This book is now available. To find links to the online bookstores that sell both the paperback and ebook forms follow this link: http://phlaunt.com/diabetes/books.php


Unfortunately, I can't sell autographed copies directly but I'd be happy to autograph any cards or bookplates you mail me. Email the address above for instructions.



September 29, 2015

The Newly Approved Basal Insulin Tresiba's Label is Disappointing

We have been hearing for quite a while about the benefits of Novo Nordisk's new, longer acting basal insulin, Tresiba, whose approval was delayed for a year while the FDA waited for cardiovascular safety data .

Well, the FDA finally approved it last week. And lo and behold, none of the main claims that have been made for Tresiba until now appear in the official, FDA-sanctioned Prescribing Information (PI), A.K.A. "label."

You can read the whole PI/label here:  http://www.novo-pi.com/tresiba.pdf

The hype was that Tresiba caused fewer hypos than existing basal insulins. If this is so, it is not demonstrated anywhere on the label. There were hefty hypo rates reported in 6 of the 7 studies summarized in the label. The percent of of people in these studies who had hypos where blood sugar dropped below 56 mg/dl via a blood sugar meter test were: 46.5%,  28.5%,  50%,  43.8%,  50.9%,  80.9% and 42.5%.  (Page 9 of the PI)

There is no way to directly compare these studies with studies of other basal insulins, as it is clear that there is really no way to compare any of these studies of Tresiba with any other study of Tresiba. When you have a range of outcomes from 28.5% to 80.9%, means and medians are worthless. There is just too much variation from study to study. So comparisons with studies of other insulins that would demonstrate superiority would have to be cherry picked. I am certain, of course, that they will be. Drug salespeople are extremely good at coming up with creative ways to promote drugs in ways that are not actually substantiated by existing research.

(It's worth noting that Toujeo's claims of causing fewer hypos were also removed from its U.S. when it was recently approved.  Toujeo is the latest incarnation of Lantus, which is being pitched as a "new" insulin though it is actually the same insulin molecule as is found in Lantus, just dressed up with a new pen and a new, higher price tag.)

The implication of the rest of the hype for Tresiba was that its longer action  would make it superior to Lantus, which currently dominates the niche for basal insulins. But oddly--and one has to assume the FDA insisted on this--the charts displayed from page 20 to page 24 of the PI clearly demonstrate that study after study found that patients on Lantus, be they Type 1s or Type 2s, saw better improvements in their A1c on Lantus than those on Tresiba. Lantus consistently achieved an improvement of  .1 to .2% in A1c.--i.e. if Tesiba lowered A1c on average to 7.1%, Lantus (called by its generic name, glargine, on the charts) brought its group down on average to 6.9%.

The reason for this may have to do with the way that Tresiba works. The chart showing the activity curve of Tresiba is worrisome. The insulin is active for 42 hours but the curve is far from flat. Since patients are told to inject it once a day, and furthermore told that they can inject it different times from day to day, the overlap between the previous day's insulin and the next day's insulin may be unpredictable.

We see from the comparison charts where Tresiba was matched with Lantus that despite the lower impact on A1c patients on Tresiba had to reduce their fast-acting insulin at meal times. This is undoubtedbly because of that very long tail of the previous day's insulin working in unpredictable ways.

The only real advantage with Tresiba is that it is available in a U200 concentrated form that will allow a single dose of up to 160 units. This is helpful for people with extreme insulin resistance who need huge doses and who, until now, had to take two or more shots of basal each day. But the population of those needing 160 units is small. For most people the main impact on them of switching to Tresiba will be that they or their insurer will be paying more for basal insulin while they will be likely to see less improvement in their control and a continuing possibility of experiencing serious hypos.

Another supposed benefit of Tresiba is that it can be mixed in the pen with fast acting Novolog, allowing it to be sold as a 70/30 insulin.  This 70/30 Tresiba/Novolog mix will be sold under the name Ryzodeg.

70/30 insulin is probably the worst form of insulin available, as putting basal and fast acting insulin into a single shot makes it impossible to match the dose of fast-acting insulin being given to the person's insulin resistance or to the the amount of carbs they eat at the meal that comes after their two daily shots. So this generic dosing of  meal-time insulin which occurs with 70/30 insulins guarantees the worst of both worlds. The choice is either more hypos or poorer control than is possible with dosing each meal separately for the rest. Insurers like it because they pay for only one prescription, not two. Some patients like it because it requires fewer shots. But no doctor who knows anything about insulin--or cares about his patients' long term outcome would prescribe this kind of insulin.

Nevertheless, you can expect to see plenty of advertising promoting this mixture of two insulins in one shot as a "convenience."  The main reason that Novo Nordisk is going to be selling Ryzodeg, of course, is not that it is good for patients. They introduced it because they know that that Lantus can not be mixed with a fast acting insulin--and Novo Nordisk is locked in a battle to the death for diabetes dollars with Sanofi, the maker of Lantus and Toujeo.

Keep in mind, both Tresiba and Toujeo come to the market under the shadow of the approaching launch of biosimilar glargine--Lantus equivalents which can be sold now since the Lantus patent has expired. For now, "can be sold" doesn't mean "will be sold." Sanofi is doing all it can to delay the day that cheaper but still effective basal insulins are available to American consumers. They just signed an agreement with Lilly, that will delay the launch of Lilly's biosimilar Lantus until 2017. This is what would be called "restraint of trade" anywhere that had real regulation of drug pricing and marketing (like, say, the EU, where biosimilar Lantus is already available). But here in the U.S. "free market" economics appear mean that companies are "free" to keep helpful drugs off the "market" as long as they pay off their big pharma peers--peers who will do the same for them in the future, to keep the profits high for both.

All of this is bad news for people with diabetes, of course, who are paying more than twice what they were paying for basal insulin just 8 years ago, while still contending with unexpected hypos. But their interests are overlooked since the business world appears to believe that the only important question about any new insulin is how much money can be extracted from those who are obliged to use it.