The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. Users are only requested to manually distribute insulin doses to counter carbohydrate (meal) consumption. This clinical trial showed that the device is safe for use. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia (low glucose levels) were reported during the study.
This version of the device is however unsafe for use in children 6 years of age or younger and in patients who require less than eight units of insulin per day. “This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease,” said Derek Rapp, president and CEO of JDRF, the leading global organization funding type 1 diabetes research.