Washington: The human pancreas naturally provides a low rate, continuous insulin known as basal insulin or background. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired.
MiniMed 670 g hybrid loop system, intended to automatically control glucose (sugar) and provide doses of appropriate persons 14 years of age and older with closed type 1 diabetes basal insulin, was approved by the Administration food and Drug (FDA).
“This first of its kind, technology can provide people with type 1 diabetes more freedom to live their lives without having to constantly and manually monitor glucose levels at baseline and administer insulin “said Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health.
The hybrid MiniMed 670 g loop system, often referred to as a closed “artificial pancreas” is intended to adjust insulin levels with little or no user input.
works by measuring glucose levels every five minutes automatically or retention administration of insulin.
The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump attached to the body; and a patch infusion pump connected to a catheter that provides insulin.
While the device automatically adjusts insulin levels, users must manually request insulin doses to counteract the consumption of carbohydrates (food).
Because the pancreas does not produce insulin in people with type 1 diabetes, patients have to constantly monitor their glucose levels throughout the day and have insulin therapy via injection with a syringe, an insulin pen or an insulin pump to avoid becoming hyperglycemic (high glucose levels).
Furthermore, the management of type 1 diabetes includes following a healthy eating plan and physical activity.
FDA evaluated the data from a clinical trial of hybrid MiniMed 670 g closed loop system that included 123 participants with type 1 diabetes
In the clinical trial included an initial period of two weeks in the hybrid closed loop system was not used followed by a three-month study during which trial participants used hybrid function closed loop system so often as possible.
No serious adverse events were reported, diabetic ketoacidosis (DKA) or severe hypoglycemia (low blood sugar) during the study.