Artificial pancreas – a breakthrough in the treatment of diabetes, its emergence in the market for a long time and it is expected with great impatience. Every year medical media publish materials that the artificial pancreas will become a reality. Today we can confidently say – Yes, it is a reality – FDA (Management on sanitary inspection behind quality of foodstuff and drug administration) has officially approved the so-called artificial pancreas environment. The first of its kind device the size of a mobile phone, designed for patients with diabetes mellitus type 1, also known as juvenile diabetes.
In people with type 1 diabetes the pancreas doesn’t produce sufficient amount of insulin for such patients, created a system of Medtronic MiniMed, a system that continuously monitors glucose levels (blood sugar) and provides the necessary insulin. The unit weight of 670 grams.
“This is a revolutionary day in the treatment of diabetes. We all have long awaited the appearance of an artificial pancreas, and will see how it works,” gives CNN a comment to the event, Dr. Robert Peel, an endocrinologist at the hospital’s South Side Northwell in Bay Shore, new York.
Artificial pancreas Medtronic MiniMed will be on sale in the spring of 2017, the device is designed for patients 14 years or older, in accordance with the information on the web site of the manufacturer.
The Medtronic system includes a glucose meter (subcutaneous electrode), a pump to supply insulin, is located on the body of the patient and the infusion is a pad connected to the pump through a small catheter to deliver insulin. The system measures the glucose levels of the patient every five minutes and as needed helps patients most of the time to maintain the glucose level within the normal range.
Diabetes mellitus type 1
Approximately 5% of people with diabetes have 1 of the disease, for him there is no cure.Patients with an autoimmune disorder needs to regularly monitor blood sugar levels constantly to insulin injections and careful coordination of insulin doses with eating and physical activity.
Non-compliance may result in either too high or too low sugar levels in the blood, any of these conditions can lead to coma.
The world’s first approved artificial pancreas device will not only measure glucose levels but also automatically to inject insulin, which, of course, greatly simplifies the life of a person with diabetes 1 type.
“Our device is designed to know about the needs of human insulin and to take urgent measures, which minimize both high and low glucose levels,” said Hooman Hakami, group President of the Medtronic Diabetes blog on the website of the company. medtronicdiabetes.com/blog/fda-approves-minimed-670g-system-worlds-first-hybrid-closed-loop-system
FDA approval
In the process of approval of the Medtronic device, FDA experts evaluated the data of clinical studies involving 123 participants.
As a result, in the course of the study, there were no serious side effects, including severe hypoglycemia. However, the FDA still requires further study the device to better understand how it behaves in real conditions, when commercially available.
The FDA approved device is only for people over 14 years, according to the manufacturers, as the distribution device and the presence of more data, we will obtain permission to use it and patients of younger ages.
Now the company is Medtronic, based in Dublin, Ireland, began a study to assess the safety and effectiveness of artificial pancreas in diabetic children aged 7 to 13 years.
