(RxWiki News) The US Food and Drug Administration (FDA) has approved a new automatic insulin pump for use in young children with type 1 diabetes.
This pump is the first of its kind to be approved for use with children between the ages of 2 and 6 who have type 1 diabetes, the FDA noted. The newly approved MiniMed 770G System is meant to monitor blood glucose and provide insulin with almost no input from the patient.
“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,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “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.”
In type 1 diabetes, the body's pancreas produces too little insulin or none at all. Insulin helps to regulate blood sugar levels. A lack of insulin in the body can lead to high blood sugar, which can be dangerous.
This condition is traditionally regulated by administering insulin via injection to help maintain safe glucose levels in the blood.
In young children, it can be difficult to continuously monitor blood sugar levels and give multiple injections over the course of a day. The MiniMed 770G System does exactly that — automatically — by continuously monitoring blood sugar levels (every five minutes) and administering insulin via pump to keep levels within a safe range.
Before approving this device, the FDA examined findings from a clinical trial that had 46 participants between the ages of 2 and 6 wear the device for three months. All participants had type 1 diabetes. The device appeared to be effective, and no serious adverse events were observed, the FDA noted.
Possible side effects of using this device included high blood sugar, low blood sugar, and irritation and redness near where the device connects with the skin. If your child has type 1 diabetes, speak with your family health care provider about the best diabetes management options for your child's unique case.
The FDA granted approval of the MiniMed 770G System to Medtronic.