Sunday, December 18, 2016 4:27:36 PM
Risks associated with the use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day.
As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings. While the device is being approved today for use in people 14 years of age and older with type 1 diabetes, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children 7-13 years old.[/ij]
http://www.rxeconsult.com/healthcare-articles/FDA-Approves-First-Artificial-Pancreas-Automatic-Insulin-Delivery-System-For-Type-1-Diabetes-1200/?utm_source=TrendMD&utm_medium=TrendMD&utm_campaign=trendmd_1
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