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Friday, 30 September 2016

FDA Approves First 'Artificial Pancreas' for Type 1 Diabetes. Medscape News. September 30, 2016

What is this, 'Artificial Pancreas'? As I do remember so far there is already some devices that work in the same way, and many prefer that they are better then one of company approved by FDA. I do not use any one of them, and I am not intend to use any in nearby future. But anyway,  what is this all about? 
In a statement, the FDA noted that risks associated with use of the system may include hypoglycemia and hyperglycemia, as well as skin irritation or redness around the device's infusion patch. In addition, this version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.
 You must be kidding! Diabetics type 1 who take less then eight units of insulin per day! And they cannot survive without insulin? They need to carry this artificial pancreas because of they will have so high blood sugar level that they even can develop DKA? You really must be kidding!
During the study, HbA1c levels dropped from 7.4% at baseline to 6.9%, and the percentage of sensor glucose values within the target range changed from 66.7% at baseline to 72.2%. No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia were reported.
Really? What events you were expected? DKA?  Diabetics type 2 with level of sugar higher then A1c>12.4% do not have DKA. Diabetics type 2 with level of sugar in blood higher then 700 mg/dl do not have DKA because of we type 2 diabetics and no one take care to test our urine for DKA. But they are, type 1 with less then 8 units of insulin daily dose, with A1c between 6.9% and 7.4 will have DKA? And then they will have drops of sugar level down to 32 mg/dl with 8 units of insulin? Really, FDA is very effective to treat American population with fake presentations.
As part of this approval, the FDA is requiring a postmarket study to better understand how the device performs in real-world settings. Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in children 7 to 13 years old with type 1 diabetes.
This is best part I do like. Good Luck mothers! Let your kids to serve as rats for clinical studies! At least, Medical Care need more patients to carry money form one pocket to another. 
     Personally, I will never let my child to be in rat cage. I prefer my child under my protection. I never really trusted in medical care. I can trust in some doctors, we all do, but in all, no thanks.  
     This device I do not need, never will use it. I do have my personal studies.  I am really very good in this. So, I take my glucose meter, check up my blood sugar level, and administer insulin, all the time only one type, Lantus Solo Star. I do not use any other types of insulin. I try many, did not work for me. Lantus Solo Star is best so far. My blood sugar dropped from A1c=9.4% down to 7.2%. Not so bad as I can say. Dose of insulin also dropped. Highest was 400 units a day. Now I no longer inject so high dose. Lantus Solo Star is easy to use, reliable, convenient, and very light to carry. I am old fashioned person. I prefer safety rather then experiments with my own body. No Thanks. Really not for me.
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FDA Approves First 'Artificial Pancreas' for Type 1 Diabetes

Miriam E Tucker
| September 28, 2016


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