The accuracy of the FreeStyle Libre Pro system was evaluated in a multicenter, prospective study
- 72 patients (18 and older) at 4 centers*
Patients wore 2 sensors on the back of each upper arm for up to 14 days. Blood glucose was also measured using FreeStyle Precision blood glucose meter and YSI references
- No fingerstick calibration was required for the reader
- >12,000 results paired with both blood glucose meter reading and YSI references
*All patients were using insulin pump or multiple daily injections for at least 2 years prior to enrollment.
With the FreeStyle Libre Pro system, 99.9% of glucose results were in Zones A and B of the Consensus Error Grid2,3
There was a high degree of agreement between FreeStyle Libre Pro sensor readings and YSI reference
- 99.9% of glucose results were in Zones A and B; 89.6% of glucose results were in Zone A
Consensus Error Grid is a tool for evaluating accuracy and can be useful for assessing clinical performance. CGM errors are translated into the potential clinical consequences of the errors. Data are plotted vs YSI reference in the scatterplot, and the error grid is divided into zones, with Zone A representing the greatest accuracy:
Zone A: No effect on clinical action (considered clinically accurate)
Zone B: Altered clinical action, but no or little effect on clinical outcome
Zone C: Altered clinical action—likely to affect clinical outcome
Zone D: Altered clinical action—could have significant medical risk
Zone E: Altered clinical action—could have dangerous consequences
Download the clinical overview of accuracy brochure
MARD was stable over the 14-day wear period1-3
MARD, which indicates the average percent disagreement between FreeStyle Libre Pro and YSI, was low at 12.3%
References: 1. FreeStyle Libre Pro Operator’s Manual. 2. Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther. 2015;17:787-794. 3. Data on file. Abbott Diabetes Care.
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FreeStyle Libre Indications and Important Safety Information
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. Review all product information before use or contact Abbott Toll Free (855-632-8658) for detailed indications for use and safety information.
For full indications for use and safety information, see more here.
FreeStyle Libre Pro Indications and Important Safety Information
The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.
IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.
CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment. WARNINGS/LIMITATIONS: The FreeStyle Libre Pro system does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss or medications containing acetaminophen (Tylenol) may experience inaccurate results with this system. The FreeStyle Libre Pro system is not approved for pregnant women, persons on dialysis, or recommended for critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. Review all product information before use or contact Abbott toll free (855-632-5297).
For full indications for use and safety information, see more here.
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