Decision expands the approval for the MiniMed 670G hybrid closed looped system to include patients aged 7 to 13.
Patients with Type I diabetes, also known as juvenile diabetes, are typically children and young adults that do not have the ability to continuously produce basal or background of insulin. As a result, continual monitoring of glucose levels is necessary, with insulin injections administered on a frequent basis.
Medtronic’s MiniMed 670G hybrid closed looped system is designed to simplify this process. A sensor attached to the body measures glucose levels under the skin every five minutes and automatically adjusts insulin delivery. The insulin is delivered via a pump strapped to the body, which is connected to an infusion patch with a catheter. The device was initially approved by the US Food and Drug Administration (FDA) in September 2017 for use in patients 14 years of age and older with type 1 diabetes.
In June 2018, the agency extended the approval to children aged 7 to 13. The expansion of the approval was based on the results of a clinical trial of the MiniMed 670G hybrid closed looped system that included 105 individuals aged 7 to 11 years old, which found no serious adverse events associated with use of the device. As part of the approval, FDA is requiring conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 7 and 13.