Earlier this year we wrote about Medtronics’ closed loop systems for controlling blood sugar levels for diabetics. These systems include continuous glucose monitors (GCMs) and insulin pumps. At the time, while approved for use in Europe, the FDA did not allow data from CGMs to be used to adjust insulin dosages. Patients had to use finger-stick blood samples that were then read by a glucometer before insulin dosage could be adjusted.
As predicted in our previous article, the FDA is now allowing the use of data from a CGM, the first step in proceeding to a closed loop system. Medtronic announced FDA clearance of its Enlite sensor for use with the company’s iPro2 Professional Continuous Glucose Monitoring (CGM). The Enlite sensor is a small, waterproof, disposable glucose sensor. It comes with an Insertor used to attach the Enlite sensor on the abdomen, where it stays in place for up to six days. A short, tiny needle sticks in the skin.
While wearing the Enlite sensor patients can live normal lives with no restrictions. The sensor records and stores glucose levels 24 hours a day, taking readings every five minutes. At the end of the six day period the patient goes to the doctor to return the Enlite for evaluation. The glucose readings are evaluated by the clinical staff to determine treatment. Having six days of data enables more informed analysis. According to Medtronic, 85 percent of the participants in a U.S. Clinical Customer Satisfaction Survey said the Enlite was comfortable to wear and 75 percent said the insertion system was easy to use.
Fully closed loop systems that take the place of the pancreas in adjusting insulin levels aren’t approved for use in the U.S. yet, but the Enlite sensor’s FDA blessing is a major step in that direction.