FDA Approves Blood Sugar Monitor without Finger Prick

FDA regulators have approved the first continuous glucose monitor that won’t require a blood sample for calibration, eliminating the need for repeated finger sticks from diabetic patients. Approved for patients with both type 1 and type 2 diabetes, Abbott’s FreeStyle Libre Flash Glucose Monitoring System uses a small sensor on the upper arm to sync current blood sugar levels to a reader device. The monitor can even record blood sugar changes during the past 8 hours, all without needing even a single drop of blood.

Up until now, most patients with diabetes have had to pick their fingers multiple times each and every day in order to be able to measure their blood sugar levels. Without accurate measurements throughout the day, blood glucose could spike or fall to dangerous levels and potentially put the patient’s life at risk. More than 30 million Americans currently use standard glucose meters and around 345,000 use continuous glucose meters that still require two daily finger pricks for calibration. Some diabetic patients are discouraged from keeping track of their sugar levels due to the pain of the constant finger sticks or the cost of medical supplies. Others use the current models of continuous glucose without performing the necessary calibration, which can lead to incorrect measurements that can endanger patient health.

Blood sugar levels that are too high, a condition called hyperglycemia, can lead to heart attacks organ damage, strokes, blindness and may even require the amputation of patients’ limbs. Hypoglycemia, or blood sugar that’s too low, can lead to confusion, seizures, loss of consciousness and diabetic coma. Patients who fail to accurately track their daily changes in blood sugar are at a greater risk for hospitalization due to complications with their diabetes.

This new and innovative technology removes virtually all barriers for diabetic patients to record their glucose levels throughout the day and properly manage their condition. Abbott’s device can’t currently be used with an insulin pump, a device that injects insulin as needed based on blood sugar measurement. However, the company is currently working on developing the improvements needed to enable that functionality. The device, whose price has yet to be disclosed, should be available in pharmacies in the coming months.