FDA: MiniMed 670G now available for younger diabetes patients

 

The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.

The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.

The approval was based on a trial that included 105 patients aged 7-11 years with type 1 diabetes. Over the course of three phases of the study, these participants wore the device both at home and remotely for approximately 3.5 months. No serious adverse events were associated with use of the device; the most common adverse events were hypoglycemia, hyperglycemia, and irritation/redness around the infusion patch.

As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.

“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The device was approved in September 2017 for use in patients aged 14 years and older.

Read more about this approval in the full FDA announcement.

[email protected]

 

The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.

The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.

The approval was based on a trial that included 105 patients aged 7-11 years with type 1 diabetes. Over the course of three phases of the study, these participants wore the device both at home and remotely for approximately 3.5 months. No serious adverse events were associated with use of the device; the most common adverse events were hypoglycemia, hyperglycemia, and irritation/redness around the infusion patch.

As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.

“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The device was approved in September 2017 for use in patients aged 14 years and older.

Read more about this approval in the full FDA announcement.

[email protected]

 

The MiniMed 670G hybrid closed loop system has been approved to help manage basal insulin levels in patients aged 7-13 years who have type 1 diabetes, according to a Food and Drug Administration announcement.

The system, manufactured by Medtronic, automatically measures insulin levels every 5 minutes using an included sensor and then delivers insulin as needed through its insulin pump and attached infusion patch.

The approval was based on a trial that included 105 patients aged 7-11 years with type 1 diabetes. Over the course of three phases of the study, these participants wore the device both at home and remotely for approximately 3.5 months. No serious adverse events were associated with use of the device; the most common adverse events were hypoglycemia, hyperglycemia, and irritation/redness around the infusion patch.

As part of this approval for children aged 7-13 years, the FDA is requiring the product developer to perform a postmarket study to evaluate how the device performs in this age group in real-world settings.

“Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

The device was approved in September 2017 for use in patients aged 14 years and older.

Read more about this approval in the full FDA announcement.

[email protected]