Important Safety Information
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FreeStyle Libre System  //  Clinical Evidence

THE FIRST AND ONLY
14 DAY PERSONAL CGM SOLUTION CLINICALLY PROVEN TO REDUCE TIME SPENT IN HYPOGLYCEMIA.2,5

FreeStyle Libre reader and sensor

The only CGM system able to maintain accuracy over
14 days without the need for fingerstick calibration or sensor coding1

  • Factory calibration delivers proven accuracy1 and eliminates patient variables3
  • Wired enzyme technology ensures stable sensor performance3
FreeStyle Libre sensor

FreeStyle Libre 14 day system achieved a MARD of 9.4% over 14 days1

MARD shows the average percent disagreement between the FreeStyle Libre 14 day system and YSI reference

Graph showing mean absolute relative difference throughout 10-day wear period

Consensus Error Grid shows FreeStyle Libre 14 day system delivers proven accuracy1

In a study, 100% of FreeStyle Libre 14 day readings fall in Zones A and B of the Consensus Error Grid4

Consensus error grid illustrates degree of agreement between FreeStyle Libre sensor readings and YSI reference

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For your patients with diabetes, FreeStyle Libre 14 day system offers better glucose control vs self-monitoring blood glucose (SMBG) testing.2,5

In clinical trials of T1D and T2D patients vs SMBG, FreeStyle Libre 14 day system was proven to:

  • Increase patient engagement and lead to more frequent monitoring2,5
  • Reduce time spent in hypoglycemia2,5
Daily patterns graph showing patient's glucose trends

Clinical trials have shown that the FreeStyle Libre 14 day system increases glucose monitoring frequency for better clinical outcomes vs SMBG2,5

Increased frequency of glucose monitoring with FreeStyle Libre system
Increased frequency of glucose monitoring with FreeStyle Libre system

The FreeStyle Libre 14 day system increased time in target range and reduced time in hypoglycemia in T1D patients vs SMBG4

Reduction of time in hypoglycemia with FreeStyle Libre system
Reduction of time in hypoglycemia with FreeStyle Libre system

With the FreeStyle Libre 14 day system, patients experienced a reduction in a range of hypoglycemia measures2

Reduction in hypoglycemia with FreeStyle Libre system

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Reference: 1. FreeStyle Libre 14 day User’s Manual. 2. Bolinder, Jan, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet 388.10057 (2016): 2254-2263. 3. Hoss et al. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects with Diabetes, Journal of Diabetes Science and Technology 2014, Vol. 8(1) 89–94. 4. Data on file. Abbott Diabetes Care. 5. Haak, Thomas, et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin- treated type 2 diabetes: a multicenter, open- label randomized controlled trial. Diabetes Therapy 8.1 (2017): 55-73

ADC-05530 Ver 3.0 09/18

FreeStyle Libre and FreeStyle Libre 14 Day Indications and Important Safety Information

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices 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 systems are intended for single patient use and require 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 systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are 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 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.

FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners.

No use of any Abbott trademark, trade name, or trade dress in this site may be made without prior written authorization of Abbott Laboratories, except to identify the product or services of the company. This website and the information contained herein is intended for use by US residents only. The product images are for illustrative purposes only.

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