The Sad State of Diabetes Technology in 2012
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1. FDA -> Medicare -> Private Insurance. They set the reimbursement codes and what each code will pay. On the internet, you throw up a website and the customer decides if your approach has value. With a pay per code system, anything outside of the sanctioned approach is either puts you at legal risk ("you aren't allowed to do this, it is not sanctioned") or financial risk ("thanks for the better way, but it disrupts money flow X in the system, so we're not giving you a reimbursement code").
2. The "Insurance is better" customer bias. The average consumer of healthcare expects to show up, slap their insurance card down and receive treatment. This abstracts them from being the direct payment entity of the services they provide. If you piss off the patient but provide the service to code, then the insurance company will pay. If you please the customer but go outside the payment structure, the insurance will not pay. Businesses get paid.
3. Regulatory and bureaucratic haze. Go to a CPAP trade show some time, it is a different world. No one is focused on improving technology and services for the CPAP user. They want to get together and lobby to prevent reimbursement cuts. They want to make sure the business they run stays good with the new regulations and can survive the next wave of audits. They do not shop machines to find what works for the patients, they have too many other stakeholders to please: referring physicians, insurance payors, what their front lines people have experience setting up. They are an extension of a giant that has far more control and say about their own business than they do. They fight back or buck the trend, they are literally audited out of business or worse.
4. Talent Deficit. There are very few places to innovate and if you find a line and do it, you have to fight the system hating you for doing it on top of the normal startup pains. It takes very special people to want to walk that road with you. For the bigs in the industry, mfgs and large insurance based sellers of equipment, their HR departments are hiring for technical positions based on resume check boxes and history with microsoft. The products they put out are heavily windows, heavily compliant, fearful of making waves with any stake holder. You can't build a better one and win because you won't get paid and don't have a network to leverage. People who could come in and really make bold moves get on the ground, see the reality and leave to do something easier.
THIS. Combine this with the fact that most consumers receive insurance through their employer (and expect this too) further abstracts them from being the payment entity.
* Measure my blood sugar at least six times a day
* Take at least six shots of insulin
* Always think what I eat. How many grams of carbohydrates is in the stuff I put into my mouth.
* I have to be very careful with alcohol. I've once woken up by an emergency crew while having a hangover. Never again. (Weed is much better though.)
* I have lots of small annoyances which require medical care every now and then.
* Influenza is a catastrophe - it will take ages and my blood glucose is not going normal easily.
Try to forget any of these, and bam your general health is at risk. It's not so easy all the time to be fully with your body and take care of yourself.
What I would love is a bloodless way of measuring my glucose, a way to get the results to my iPhone and a way to calculate the amount of carbohydrates I have in front of me. No, a database of different foods is not enough. I have to do it 4-5 times a day, remember.
When you have to do something many times a day for the rest of your life, it should be as easy as possible.
Unless you have a 6% HA1C on shots, get a pump and live decades longer.
I seriously doubt if I would've been up to doing either while managing injections instead of button presses.
I don't know, obviously, not being diabetic myself, but I will say she went on the pump really soon after being diagnosed and didn't really have a chance to establish a routine first, and that probably played a large part in her doing better on shots right now. I've been encouraging her to start thinking about using the pump again, as I do feel that, used correctly, as I believe it is a better method, but she has to do what she feels works best for her.
Being a developer myself, the idea that she has to use a custom cable and custom software to manage the data she has in her meter drives me a bit nuts. But the meter industry is, IMO, full of companies that don't really want to help users, they just want to get rich off of diabetics. I know thats a bit cynical, and I'm sure there are companies that sincerely care as well, but it's how I often feel about the meter industry.
In short, the pump CGM combo it is the best thing I have ever done.
I am astounded there is not a close loop system yet.
At the time this was presented, the results were billed as the biggest advance in Intensive Care in recent history. The authors claimed to have hard numbers, showing that closed loop control of blood sugar for ICU patients was delivering (something like 40% if memory serves me???) fewer deaths for ICU patients. I'm not in the ICU area, so I don't know if the techniques outlined in the paper made it into clinical practice or real products. If so, you'd think it would trickle down into diabetes management. As a non-diabetic, am I completely misunderstanding the problem?
The International Federation of Automatic Control (IFAC) is the peak body for control research, so there's a good chance you will read about any new closed loop system there.
[1] http://www.sysid2006.org/Wednesday.html#web4
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Edit: A couple more links from my poking around. Might provide some reading if closed loop control of diabetes is of interest.
http://www.medschl.cam.ac.uk/paediatrics/pages/wilinska.html
Closed Loop Insulin Infusion for Critically Ill Patients (with pictures of an actual device):
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Edit: Found the actual numbers here: http://cordis.europa.eu/search/index.cfm?fuseaction=proj.doc...
42% reduction in mortality, compared to the old insulin control method, which I presume is open-loop?
There is one nice feature of having a pump, with an always attached device you can get warnings when your asleep which can save your life. Many of these devices will either beep or vibrate or both when you enter a danger range. Even if it does not alert you it could alert whomever your sleeping with; even pets will take notice and possibly wake ya.
Last note, most insurance plans expect the pump to be replaced after a couple of years so find out up front how many years before you should expect to replace it.
His assertion is that he current method of treating diabetes is based on classical mechanics, 1-in-1-out, etc., where you measure your blood sugar and try to manually maintain it at a certain level with sugar and insulin.
But ...
1) the human body is a complex, non-linear, dynamic system. It is based on and responds to signalling, genetic triggers, etc., and ...
2) you don't need to micromanage your body, it will take care of itself as long as you don't essentially poison it.
3) the old method presumes there is something wrong with your body, when in actuality, the problem is with the way your body reacts to 'modern' (post-agricultural) foods. Diabetes is a symptom of that, so cut those foods out, and diabetes goes away.
It may not apply to all types of diabetes, IANAE, but seriously, stop by a bookstore and spend 20m reading just the first chapter (maybe 2, can't recall exactly), and figure out if it's something worth looking into further.
1. http://www.amazon.com/The-New-Evolution-Diet-Paleolithic/dp/...
The comment you replied to is presumably about type 1 diabetes, an inflammatory disease that destroys the body's ability to produce insulin. You are referring to type 2 diabetes.
I went from >12% to <6% A1C by cutting out carbs, taking a low dose of metformin (750mg slow release per day) and throwing in a bit more light to moderate exercise.
Credit to Dr. Bernstein (http://www.diabetes-book.com/) who is a type I diabetic himself, but really we're now hearing the same things from Taubes, Lustig, the Paleo folks and many others.
Obviously low carb diets alone aren't the whole solution. Berstein's book contains a wealth of information on living with diabetes well into old age. It's a great read for diabetics or for anyone caring for a diabetic.
Just to clarify, I'm not selling notions of curing type 1 diabetes through diet. If you're type 1 you will need insulin. Even type 2 may require insulin.
The point I'm trying to make is that in both diseases (type 1 and 2) control of blood sugar is key to reducing mortality. Reducing carb intake will result in lower blood sugar rises which will require less insulin to counter. Less insulin means less chance of hypoglycemic events. By minimizing these control inputs you can balance your blood sugar in the normal range and prevent and even reverse the damage to your body from diabetes.
If you respect Ray Kurzweil's ideas, which I think a fair number of people here do, then I would suggest anyone with diabetes concerns (at risk, got it, etc) read his book "Transcend."
Direct quote:
"Largely because of excessive consumption of simple carbohydrates and sugary foods, the number of people with type 2 diabetes in the United States has increased tenfold in the past 35 years, and as of 2008, type 2 diabetes affected over 21 million Americans. In just the 10 years between 1997 and 2007, the incidence of type 2 diabetes nearly doubled in the United States, from 4.8 to 9.1 per 1,000 people."
The reason why Paleo is recommended is because high glycemic index carbohydrates are virtually eliminated. That certainly is not the only diet that accomplishes this. In Transcend, a low calorie somewhat Japanese diet is encouraged. That is something that is extremely difficult, behaviorally, for Westerners to strictly adapt. In my own experience it took about 3-4 years of behavior modification to do that, and I ended up medically underweight. "Paleo", at least for males from what I've seen, is fairly easy.
If you disagree with Kurzweil, well then I can't say much else, he certainly knows more about this than I do.
One of the things that started the disease was an influenza back when I was kid. I also have the genes from my family, so suddenly I didn't have insulin in my body anymore. It has nothing to do with my lifestyles.
I've been taking care of my disease since I was a kid and believe me, I need my daily shots of insulin.
Our company, MyNetDiary, provides an awesome food diary app (the only 5-star paid diet app on the iPhone). It's highly polished and uses some very advanced tech under the hood. The most frequent word in user review is "easy".
For almost a year, we are working on a special diabetes tracking app built on top of it. It does not integrate with BG hardware (would need FDA Class 1 approval), but we are exploring options.
The app will help you keep track of foods, exercise, and - with manual entry - your BG readings and insulin.
We've been doing this for 5 years and know what we are talking about - this is the best app for tracking diabetes.
It's a couple of weeks from release, we are testing release candidate. If you are interested in trying it sooner, we can provide an Ad-Hoc build for iPhone. More info: http://www.mynetdiary.com/diabetes-tracker-for-iPhone.html
My contact info is in profile.
This is the part that still both sickens and baffles me. I had onset at about 20, despite not looking like a typical diabetic (5-foot-8, 140lbs). 11-years ago, my endocrinologist made sure to drill into my head this margin of error, and that the margin of error was highest in situations where I would be hypoglycemic or suffering from an insulin reaction. As a diabetic himself (and for the record, having a diabetic endocrinologist is the best thing you can hope for), he was all too aware and frustrated with the limitations.
Now, a few days ago it was pointed out that the margin of error for test strips in a medical facility is much lower. The one thing I've been waiting for is to get that level of accuracy. If there's one thing I want, it's that. More than anything. I couldn't give a rat's ass about anything else.
Getting that number consistent could've sped up the timeline in which it took to get my blood sugar levels to be consistent. I'm not terribly methodical, but at the end of the day my endocrinologist doesn't complain when my HA1C results are consistently between 6.2 and 6.6, and have been for the past 6 years, despite relying only on subcutaneous injections(1) and continued dietary changes and experimentation. However, I bet I could keep it at 6 on the nose -- while "cheating" a bit more -- if I knew that a reading was nearly dead-nuts on every time.
(1) Not a fan of pumps. My mother was and still is on TPN. After seeing the joys of dealing with infections, I prefer the very rare dermatitis.
* Within ±0.83 mmol/L of lab results at concentrations of under 4.2 mmol/L
* Within ±20% of lab results at 4.2 mmol/L or more
Companies are juggling cost, reliability and performance/accuracy, with the first two generally winning in the marketplace as key selling points.
Some devices offer significantly better accuracy than 20%, depending on the market that you are in (not all are for sale in USA, IIRC).
So they make millions off insurance for the strips at the expense of society and the people who cannot get insurance.
If they ever invented a $100 device that doesn't need strips they would completely destroy the crazy profit they have.
The article didn't mention the Contour USB which is completely digital but of course still needs strips.
For anyone who is disinclined to get a pump, I highly recommend the Bayer Contour USB. I've had it for a week and it is _leagues_ better than anything else I've used. I was so thrilled when I discovered that with it I could simply access my readings as an SQLite DB rather than the hell of trying to communicate with and parse the data from anything from Lifescan over a bloody 3.5mm serial port.
I'd say that is more compelling evidence that the state of technology is good. Lack of bluetooth may be somewhat inconvenient, but it is not life threatening...and the lack of bluetooth is less inconvenient than dialysis several times a week.
I'm not unsympathetic toward the author's medical condition, but proprietary interfaces are even part and parcel of devices as successful as the iPhone, and it's hard to see a strong medical case for adding bluetooth to a medical device...sometimes hardwiring is just a better solution for life critical applications.
I'm concerned with quality of life and convenience. As the other commenter said, if it's something you are doing 10 times a day, thousands of times a year, you want it to be convenient.
Diabetes wears on you. It's the incessant nature of it that hurts.
There's a legitimate philosophy behind not treating medical devices as electronic gadgets.
It sounds stupid on the face of it, but for a 13 years old already stuffed to death with complexes, the difference between a bluetooth device no one sees and can be checked quickly, and something with tubes running through your clothes to your pants can be like night and day.
I'm willing to take some of that blame for being shallow, but not all of it. I know I wasn't the last teen diabetic w/ similar thoughts.
Think education, health, law ...
Any more?
In fact from the list of the oldest professions only the "oldest" is free from regulation (only, for the most part, suffering from prohibition).
But that was not my main concern...
The worst thing is that instead of using the the data in combination with all their patients to form some sort of massive dataset that could help everyone... they print a chart for my file.
The only trouble with things going inside the body is the need to get FDA approval and the vigorous testing that goes along with that.
At the same time, why do we even need diabetes technology? Just go on a low-carb diet. My grandma was borderline diabetic a year ago. She was getting very worried, so I was finally able to convince her to try it and now her test results are great.
Even if you're a type I diabetic, this will manage your symptoms although it won't cure you. Check out "Good Calories Bad Calories" by Gary Taubes.
The latests theories point to gluten to cause a leaky gut, that causes complex foreign molecules to enter the bloodstream, and as some molecules are similar to our own, this causes the immune system to attack some cells in our body. The cells in the pancreas that make insulin are one of these.
The bad news is that if you have Type 1, you can't be cured, and need insulin for life.