The First Artificial Pancreas for Type 1 Diabetes Approved by FDA!
FDA approves world’s first automatic insulin release system, meaning artificial pancreas on Wednesday, 28th of September, 2016.Automatic insulin release system will make patients’ who have to live with this disease, life easier.
Dr. Jeffrey Shuren from FDA states that this device will give a great freedom to type 1 diabetes patients and save them from controlling blood sugar levels manually and adjusting insulin levels.
MiniMed 670G, produced by Medtronic, injects necessary insulin keeping the track of blood sugar. System automatically shuts down when blood sugar is too low. However, the device is far from being a fully automatized pancreas yet. Type 1 diabetes patients still must determine how much carbohydrates they take and put this information on the system.
According to the information from Medtronic, device will be released in 2017 spring. FDA approval is valid for patients over 14 for now. Company pursued the clinical studies for younger patients, too.
Type 1 diabetes is an autoimmune disease, which occurs when body attacks insulin producing cells by mistake. Insulin is a key hormone in brains’ and cells’ consumption of sugar as fuel. Patients with type 1 diabetes have to take it from outside several times a day as they cannot produce insulin anymore. However, it is not very easy to calculate how much insulin to take and taking excessive insulin may be dangerous, even fatal.
At this very point, technology comes for help. New device follows blood sugar constantly with a sophisticated software to calculate necessary insulin amount and melts it to lower the blood sugar. Device does this with a thin catheter placed under skin. This catheter is connected to an insulin pump. Place of insulin release should be replaced once in three days.
If blood sugar decreases too much, device stops insulin release. Former president of Juvenile Diabetes Organization, Aaron Kowalski, claims that artificial pancreas will make many lives more quality even if there is not a certain cure for diabetes. Patients in clinical experiments did not only manage a better sugar control, they also had a more quality life. Although providing a biological cure or protection from diabetes will take many more years, this is a good advancement.
18 different artificial pancreas device is under the process of development in our time. Medtronic has been the first company achieving to get an FDA approval. FDA approval was taken after clinical studies conducted on 123 type 1 diabetes patients. In this group, no case of serious hypoglycemia and diabetic ketoacidosis was reported.
Source: U.S. Food and Drug Administration, news release, Sept. 28, 2016; Melinda Rose, Houston-area; JDRF, statement, Sept. 28, 2016; Gerald Bernstein, endocrinologist and coordinator, Friedman Diabetes Program, Lenox Hill Hospital, New York City