The U.S. Food and Drug Administration (FDA), approved Wednesday a new “artificial pancreas” created by the company Medtronic to treat diabetes type 1. The device monitors blood sugar levels on patients and delivers insulin when required, a breakthrough in the health industry according to experts.
Medtronic’s newest diabetes monitor is the MiniMed 670G, a tracking device that checks on the patient’s blood sugar levels every five minutes and delivers insulin when the body requires it in an automatical way, something that existing products in the market can’t achieve.
The FDA evaluated the product over the course of three months with the help of a clinical trial, where 124 diabetes patients tested the MiniMed’s abilities and reported their experiences to the Administration. The approval of the product has been a surprise for the health industry since it wasn’t expected until 2017.
“We’ve been looking forward to a day like this for a long time. Ultimately it means less concern, less burden, more freedom and less fear,” said Derek Rapp, chief executive of the Juvenile Diabetes Research Foundation in an interview.
Controlling diabetes through an artificial pancreas
Of the 29 million Americans in the country, five percent suffer from diabetes type 1 which is an autoimmune disease in which the body destroys pancreatic cells by mistake. This causes the body to stop producing hormones such as glucagon or insulin that help the body control blood sugar.
According to the Centers for Disease Control and Prevention (CDC), researchers believe that diabetes type 1 originates after patients expose themselves to an “environmental trigger,” which acts by causing the immune system to attack cells in the pancreas.
Patients that suffer from the disease need to monitor continuously their blood sugar levels and administer insulin when required. However, if the body has too much insulin, the blood sugar levels can drop to dangerous levels. If the disease is not taken care of, it can lead to heart diseases, kidney failure, stroke, and blindness.
“My husband and I, for the past seven years, we woke up every night at 10, at midnight and at 3 a.m,” said Angie Platt, a Californian mom who’s 13-year old son Jonathan suffers from the disease to NBC News.
Platt explained that she and her husband had to wake Jonathan up three times at night and measure his blood levels if they were too low they had to force him to drink some juice. However, Jonathan was selected to be one of the 124 patients participating in the FDA’s clinical trials to evaluate Medtronic’s MiniMed 670G for three months, which allowed him to be more “free,” according to Platt.
The company’s new device works by connecting an under-the-skin sensor to measure glucose levels in the body, with an insulin pump that is wired to the patient’s body along with a catheter and an infusion patch that delivers insulin to the blood.
There are already several wearable devices in the health industry that help patients monitor their blood sugar levels. However, Medtronic’s MiniMed is the first to work “automatically” allowing the patient to be more care-free about the dangerous disease.
The MiniMed 670G still requires the patient to alert the system when it’s about to eat so insulin levels can be matched to the number of calories being consumed. The device also needs to be informed when the patient is performing physical activities.
“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,” explained Jeffrey Shuren, the director of the FDA’s medical device branch.
The Administration found no episodes of severe hypoglycemia or ketoacidosis in patients during the clinical trials, but 28 participants experienced “device-related events” in which the hardware or the software presented issues. According to the FDA, those issues were solved at home.
After the clinical trials had ended, the FDA approved the use of the product for patients of 14-years old and older who have diabetes type 1. The FDA now plans to monitor the product’s functioning when it hits the market in the spring of 2017.
Medtronic hasn’t announced the official price of the MiniMed 670G, but expected prices are around the $6,000 and $9,000. The company is offering the product to insure companies so that it can be added to their health plans for diabetes patients.
“It is going to change the life with of people with diabetes if it’s properly instituted,” said Satish Garg, a medicine professor at the Barbara Davis Center for Diabetes at the University of Colorado.
Source: FDA