Key clinical outcomes support the use of the FreeStyle Libre Portfolio1-8,*
[95% CI; -0.70, -0.39]
[187 (13.7%) to 32 (4.7%) at 12 months; P<0.05]
[<55 mg/dL; −0.38/24-h day; P<0.0001]
“Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomized controlled trial”
[<55 mg/dL; −0.12/24-h day; P=0.0017]
“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”
[18.5% to 7.7%; P<0.05]
“Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)”
[5.8% to 2.9%; P<0.0001]
“Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study”
* Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 system has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore, the study data is applicable to both products.
† A meta-analysis of RCTs and single arm studies (in addition to real world observational studies) on the impact of flash continuous glucose monitoring on glycemic control as measured by HbA1c.
ǂ vs SMBG.
§ For FreeStyle Libre 14 day system: Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
|| For FreeStyle Libre 2 system: Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours.
References: 1. Yaron, Marianna, Eytan Roitman, Genya Aharon-Hananel, Zohar Landau, Tali Ganz, Ilan Yanuv, Aliza Rozenberg et al. “Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes.” Diabetes Care 42, no. 7 (2019): 1178-1184. 2. Evans, Mark, Zoë Welsh, Sara Ells, and Alexander Seibold. “The impact of flash glucose monitoring on glycaemic control as measured by HbA1c: a meta-analysis of clinical trials and real-world observational studies.” Diabetes Therapy 11, no. 1 (2020): 83-95. 3. Campbell, Fiona M., Nuala P. Murphy, Caroline Stewart, Torben Biester, and Olga Kordonouri. “Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study.” Pediatric Diabetes 19, no. 7 (2018): 1294-1301. 4. Fokkert, Marion, Peter van Dijk, Mireille Edens, Eglantine Barents, Jeanine Mollema, Robbert Slingerland, Reinold Gans, and Henk Bilo. “Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4).” BMJ Open Diabetes Research and Care 7, no. 1 (2019). https://doi.org/10.1136/bmjdrc-2019-000809. 5. Bergenstal, Richard M., Matthew SD Kerr, Gregory J. Roberts, Diana Souto, Yelena Nabutovsky, and Irl B. Hirsch. “69-OR: Freestyle Libre System Use Is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes.” (2020). Diabetes 69, no. Supplement 1 (2020). https://doi.org/10.2337/db20-69-or. 6. Haak, Thomas, Hélène Hanaire, Ramzi Ajjan, Norbert Hermanns, Jean-Pierre Riveline, and Gerry Rayman. “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, no. 1 (2017): 55-73. 7. Bolinder, Jan, Ramiro Antuna, Petronella Geelhoed-Duijvestijn, Jens Kröger, and Raimund Weitgasser. “Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.” The Lancet 388, no. 10057 (2016): 2254-2263. 8. Charleer, Sara, Christophe De Block, Liesbeth Van Huffel, Ben Broos, Steffen Fieuws, Frank Nobels, Chantal Mathieu, and Pieter Gillard. “Quality of life and glucose control after 1 year of nationwide reimbursement of intermittently scanned continuous glucose monitoring in adults living with type 1 diabetes (FUTURE): a prospective observational real-world cohort study.” Diabetes Care 43, no. 2 (2020): 389-397.
ADC-17131 v4.0 03/21
Indications and Important Safety Information
FreeStyle Libre 14 day system: The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. 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 14 day 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 14 day 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. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information. For full indications for use and safety information, see more here.
FreeStyle Libre 2 system: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*
WARNINGS/LIMITATIONS*: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.
* Please refer to www.freestylelibre.us for the indications and important safety information.
The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. 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 the prior written authorization of Abbott Laboratories, except to identify the product or services of the company. Product images are for illustrative purposes only.
ADC-25347 v3.0 12/20