FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes. September 30, 2016

WEDNESDAY, Sept. 28, 2016 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system -- a so-called "artificial pancreas" -- for people with type 1 diabetes.

The first question is, why this system for diabetics type 1, but not for diabetics type 2 like myself who take insulin in the same way as it is type 1 diabetics? Really, what is difference between me, type 2 diabetic who takes 300 units of insulin dose daily, and those diabetics type 1 who take less then 25 units daily dose? Do I need this system or not? 
Well, it is interesting to take a look at what this system is about.

 "This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

Freedom is good, but it is also come with price.

The device -- Medtronic's MiniMed 670G -- is what's known as a hybrid closed-loop system. That means it monitors blood sugar and then delivers necessary background (also known as basal) insulin doses. The device will also shut off when blood sugar levels drop too low. 

So, something would be connected with my blood and hang-on aside of my body to provide constant monitoring and delivery. Do I really need it? I can use this system to monitor my glucose level once a week or month that I would see the pattern how blood sugar rises and drops during day and night with my routine lifestyle. But to administer insulin ?... No, thanks.
     It is presented that device would shut down system when sugar level drops. Really, it is too late for that.  The insulin is already in blood, so, regardless system shut down the blood sugar will go down, and no  one do know very well for how long it will drop and how down it will go.
     As I told many times, all treatment options based on the level of sugar in blood, and it is constantly changing variable.  There are must be different approach in diabetes treatment, regardless of it type. As diabetic type 2 on high dose of insulin I can feel my blood sugar dropping at the time when monitor show perfect level of sugar in blood. I can feel it, and I have to take actions long before sugar drops low. The system does not provide this freedom. At first, it is because of diabetic does not take own actions but relay on device that device will do the job. It never will happen. It did not happen yet. In hospitals many diabetics die because of low blood sugar, result of wrong treatment therapy.

However, this device isn't yet a fully automated artificial pancreas. People with type 1 diabetes will still need to figure out how many carbohydrates are in their food, and enter that information into the system, the agency noted.

Another pretty stubborn understanding. Diabetes  is not about carbs eating but it is the Gap between insulin in demand and insulin available in secretion. Now  man made pancreas would count the dose of insulin according to the amount of carbs one put into system. Then it would be automatically pool my blood with insulin. O, no, this is really not for me. I prefer to relay on my own brain. 

The device does this via a small catheter inserted beneath the skin and attached to a tube that's attached to an insulin pump. This insulin delivery site needs to be changed approximately every three days.

Why site must be changed? Because it would be rash on the spot. Now, after three days the site must be changed, and then another three days, another red spot from constant use of device. It must be taken into consideration that insulin deliveries every day. Many diabetics develop rash on side and scars. It is not one week treatment, it is life long attachment to  our bodies. No, thanks. I better to stay with my trusted Lantus Solo Star.  

And that's where this new technology will help. The device has a continuous glucose monitor that constantly measures blood sugar levels. A sophisticated computer algorithm then figures out if someone's blood sugar levels are too low or too high, and when too high, will give the correct insulin dose to bring the blood sugar level down.

Computer is perfect in counting. But computer does not have ability to provide understanding how to combine together carbs, fats, activities, and brain energy consumption. So far our medical care providers still diagnose dose of insulin as  1 out of 4 part of our weight, in units. Why do not start from the simple task, just find out how level of sugar and dose of insulin can be connected. This is already every difficult task, without adding carbs and calories counting. There is no one formula so far how to dose insulin according to the level of sugar in blood.

In a statement, Aaron Kowalski, chief mission officer for JDRF (formerly the Juvenile Diabetes Research Foundation), said until there's a cure for type 1 diabetes, "I know that the artificial pancreas will change many lives for the better."

Well, if so far for almost 100 years they still not able to find the dose of insulin and how to use it, if diabetes today number 7 cause of Death in America and number 4 cause of Death in NYC, then I will not take it for granted that my life would be changed for better with any Research Foundation. It is simple business law, no ill patient no longer paying patient. They need us, so there is no one reason to trust they are looking for cure. No, They are looking for studies financing, that's all. 

According to the agency, the FDA approval is based on data from a clinical trial of 123 people with type 1 diabetes. The study volunteers wore the device for three months. No serious low blood sugar (hypoglycemia) events occurred. And no one experienced diabetic ketoacidosis, a serious complication that can occur if someone doesn't get enough insulin, according to the American Diabetes Association. 

True or False? 
True. Diabetes is nothing about type of it, type 2, type 1 , LADA, MODY, does not matter. It is all about numbers, the level of sugar in blood. Now, if the level of sugar in blood is higher then normal, it does not mean there are ketoacidosis would be happen. To get this condition diabetic must have over 400 mg/dl level of sugar  in blood. With this so high level of sugar in blood diabetic must be treated in ICU rather then jump around street with artificial pancreas. But when level of sugar is not so high then there is no dangerously low blood sugar drops. No one would take me to studies like that. I am in too poor medical condition. Wrong dose of insulin put me on swings from high to low. They prefer to study diabetics with a little bit abnormal level of sugar and then pretend that it works for everyone diabetic. The same as it is size of our clothing. Take 'S' size, and then cut it and spread aside to get size one need such as 5X. Does it works? of cause it does. This is why we looks so ugly and ridiculous.
       This is basal tricks our ADA WHO and all medical Industry play with population.  Just next dirty trick. I do not play games with my life. I prefer to take Lantus Solo Star every day, and take readings before every shot. At least nothing hang on on site of my body, an rash.
      I will not use this system.

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FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes

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