The FDA has expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm.
The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system. Along with the added convenience of the new sensor site, the company said in a statement that the new location is also more accurate, demonstrating a mean absolute relative difference (MARD) of 8.7 percent following calibration.
“We are very pleased to offer this added flexibility for those who rely on our therapies for their diabetes management needs,” Alejandro Galindo, president of Medtronic's Intensive Insulin Management division, said in a statement.
Closed loop or “artificial pancreas” systems combine a CGM and an insulin pump to regulate a user’s insulin with minimal interaction required from the patient. The system isn’t completely automated — users need to manually request insulin doses to counter carbohydrate (meal) consumption. Readings from the Guardian Sensor 3 are read by the company’s SmartGuard algorithm, which uses the data to automatically adjust basal insulin delivery dosages every five minutes.
"The performance of the Guardian Sensor 3 has been extremely impressive and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs," Dr. Bruce Bode, a clinical associate professor at Emory University, said in a statement from Medtronic. "These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimizing outcomes through technological advancements - that can prove to be just as meaningful for quality of life.”
The full MiniMed 670G system, which was approved by the FDA in September 2016, is indicated for Type 1 diabetes patients aged 14 years and older. A retrospective blog post recently published by heads of the agency described how regulators evaluated Medtronic’s system and laid the groundwork for future artificial pancreas approvals.