Published: Fri, September 30, 2016
Health | By Constance Griffith

FDA approves device to automatically manage diabetes

FDA approves device to automatically manage diabetes

Medtronic Plc won USA approval on Wednesday for an "artificial pancreas" that is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes, freeing them from continually monitoring insulin levels throughout each day. The Medtronic MiniMed 670G system continuously monitors glucose (blood sugar) levels and delivers needed insulin to patients. Because the pancreas does not make insulin in people with type 1 diabetes, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen or insulin pump to avoid becoming hyperglycemic (high glucose levels). While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption, FDA said. For instance, insulin needs vary depending on what a person ate hours earlier, whether the individual has exercised recently and if the person is having a growth spurt, going through puberty, menstruating, getting sick, or feeling stressed or excited. Eventually the pancreas will not be able to make enough insulin to respond to blood sugar levels.

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. Many patients also wear sensors that continually monitor their glucose levels.

About 5 percent of the 29 million Americans with diabetes have Type-1 diabetes. The system's algorithm is created to keep patients within a target glucose level range for as much time as possible throughout the entire day. "After years of laying the ground work, this breakthrough is a testament to the reason JDRF exists-to help people with Type 1 diabetes lead better, safer, healthier lives while we continue on the path to cure and prevent the disease altogether".

· No serious adverse events, diabetic ketoacidosis, or severe hypoglycemia were reported.

While the device can now only be marketed for Type 1, doctors said it could eventually be used by those with Type 2 diabetes, where the body gradually loses the ability to produce or use insulin.

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Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes Center at Harvard University, said the approval was a big step forward.

Insulin is produced and released through the pancreas - that's where the term "artificial pancreas" comes in. Medtronic is now performing trials investigating the use of the 670G in patients 7 - 13 years old.

"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes".

Satish Garg, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado in Denver, who helped conduct trials for the MiniMed 670G, said he is concerned about whether insurance companies will pay for the new system.

The device, made by Medtronic, is called the MiniMed 670G.

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