The US Food and Drug Administration (FDA) has approved Medtronic’s MiniMed 770G System for use by paediatric patients aged between two and six years with type 1 diabetes.
The system is a hybrid closed-loop diabetes management device, which automatically monitors glucose and enables appropriate basal insulin doses with little or no input from the users or their caregivers.
It is designed to measure the glucose levels in the body every five minutes and automatically adjust insulin delivery by either administering or withholding insulin.
It is a Bluetooth-enabled version of the company’s previously approved MiniMed 670G System.
FDA Commissioner Stephen Hahn said: “Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition.
“The FDA is dedicated to promoting policies that support the development of new technologies based on these advances and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition, which can particularly impact children, is safe and effective.”
The approval was based on the outcomes from a clinical trial that included 46 pediatric type 1 diabetes patients.
The FDA also noted that Medtronic MiniMed 770G System is a first-of-a-kind device to be cleared for use in patients in the age category.
It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population, said the agency.
Patients with type 1 diabetes condition require constant monitoring of glucose levels throughout the day. Usually, to maintain adequate glucose levels in order to avoid becoming hyperglycemic or hypoglycaemic, insulin is injected with a syringe, pen or pump.
In June, Medtronic secured CE Mark certification for its MiniMed 780G system for the treatment of type 1 diabetics between the ages of seven and 80 years.