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First CGM system without ‘finger stick’ calibration approved for adults with diabetes
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The FDA recently approved the first continuous glucose monitoring system that does not require calibration with a “finger stick” for adults with diabetes, according to an FDA release.
The new system, FreeStyle Libre Flash Glucose Monitoring System (Abbott), uses a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels without the need for finger stick testing. Glucose levels can be determined by users waving a mobile reader above the sensor wire, which will let the reader know if levels are too high or too low as well as their trajectory. The system is indicated for adults aged at least 18 years with diabetes and can be worn for up to 10 days after a 12-hour start-up period.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in the release. “This system allows people with diabetes to avoid the additional step of finger stick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes — with a wave of the mobile reader.”
Data from a clinical study of adults aged at least 18 years were used to compare the effectiveness of the FreeStyle system and readings from an established laboratory method used for blood glucose analysis.
Risks with use of the system may include hypoglycemia or hyperglycemia as well as mild skin irritations around the insertion site. The system does not provide real-time alerts or alarms.