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“Artificial Pancreas” Makes U.S. Debut
Medtronic has announced the U.S. launch of the MiniMed 670G system––the world's first hybrid closed-loop system for patients with type-1 diabetes (T1D). It is the only insulin pump approved by the FDA that allows personalized, automated delivery of basal insulin, the background insulin needed to maintain stable blood sugar levels throughout the day and night.
The MiniMed 670G system also features the Contour Next Link 2.4 blood glucose monitoring system developed by Ascensia Diabetes Care. The system was approved by the FDA in September 2016 for the treatment of patients 14 years of age or older with T1D. It may not be safe for patients under 7 years of age or for those using less than 8 units of insulin per day.
Data from a pivotal trial published in the Journal of the American Medical Association demonstrated less glycemic variability; more time in the target range; less exposure to hypoglycemia and hyperglycemia; and reduced hemoglobin A1c among patients using the MiniMed 670G system. “Real world” use of the system in a customer training phase showed consistent improved outcomes across several key areas, including the time in range (74%), and a greater median time in the auto mode (92%).
An estimated 1.25 million Americans have T1D, an autoimmune disease in which the pancreas stops producing insulin. T1D can affect both children and adults at any age and leads to dependence on multiple daily injections of insulin or an insulin pump. The complications stemming from high and low blood sugar levels can lead to serious short- and long-term complications, including kidney failure, blindness, nerve damage, heart attack, stroke, and pregnancy complications. It has been estimated that less than one third of people with T1D in the United States are achieving target levels of blood-glucose control.
Source: Medtronic; June 7, 2017.