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The Food and Drug Administration has approved the first automated insulin delivery device for patients aged 14 years and older with type 1 diabetes.
The MiniMed 670G by Medtronic – an “artificial pancreas” – is a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses. The system was shown in a study of 123 individuals with type 1 diabetes to be safe for those aged 14 and older; no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia occurred during a 3-month period when the system was used as frequently as possible by study subjects.
“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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press statement.
As part of its approval of the device, the FDA is requiring a postmarket study of its performance in real-world settings, and although the approved version of the device is unsafe for use in children aged 6 years and younger and in those who require fewer than eight units of insulin daily, Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
The Food and Drug Administration has approved the first automated insulin delivery device for patients aged 14 years and older with type 1 diabetes.
The MiniMed 670G by Medtronic – an “artificial pancreas” – is a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses. The system was shown in a study of 123 individuals with type 1 diabetes to be safe for those aged 14 and older; no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia occurred during a 3-month period when the system was used as frequently as possible by study subjects.
“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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press statement.
As part of its approval of the device, the FDA is requiring a postmarket study of its performance in real-world settings, and although the approved version of the device is unsafe for use in children aged 6 years and younger and in those who require fewer than eight units of insulin daily, Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.
The Food and Drug Administration has approved the first automated insulin delivery device for patients aged 14 years and older with type 1 diabetes.
The MiniMed 670G by Medtronic – an “artificial pancreas” – is a hybrid closed-loop system designed to automatically monitor glucose and deliver appropriate basal insulin doses. The system was shown in a study of 123 individuals with type 1 diabetes to be safe for those aged 14 and older; no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia occurred during a 3-month period when the system was used as frequently as possible by study subjects.
“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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press statement.
As part of its approval of the device, the FDA is requiring a postmarket study of its performance in real-world settings, and although the approved version of the device is unsafe for use in children aged 6 years and younger and in those who require fewer than eight units of insulin daily, Medtronic is currently evaluating the safety and efficacy of the device in children aged 7-13 years.