(RxWiki News) The US Food and Drug Administration (FDA) recently expanded the approval of the first "artificial pancreas" for use in children.
The device, called the MiniMed 670G hybrid closed-loop system, was approved in September of 2017 for use in patients who have type 1 diabetes and are 14 years old or older.
Now, the FDA has approved the device for use in children who have type 1 diabetes and are between the ages of 7 and 13.
The pancreas is responsible for supplying insulin to the body. However, in patients with diabetes, the body is unable to produce or respond to insulin and is therefore unable to regulate blood sugar. As a result, insulin is required, in addition to the monitoring of blood sugar levels.
This hybrid closed-loop device works by monitoring blood glucose every five minutes and automatically adjusting how much insulin the user will receive based on the glucose reading. The system will adjust insulin delivery by administering or withholding insulin.
The system includes a sensor that measures blood sugar levels, an insulin pump and an infusion patch that delivers insulin.
Although the device automatically adjusts insulin levels, users need to manually request insulin doses to address carbohydrate intake at mealtime.
The use of this device may lead to lower or higher blood sugar levels, as well as skin irritation or redness around the device’s infusion patch.
The FDA's expanded approval was granted to Medtronic.
Written By Anyssa Garza, PharmD, BCMAS