* A meta-analysis of real-world observational studies amongst type 1 and type 2 people with diabetes, including children and adults, was conducted to assess the impact of using the FreeStyle Libre 14 day system on A1C. † Based on a comparison of list prices of the FreeStyle Libre 14 day system vs competitors' CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any. REFERENCES: 1. Ajjan R. Insights from real world use of flash continuous glucose monitoring. Symposium conducted at: American Diabetes Association 78th Scientific Sessions; June 2018; Orlando, FL. 2. Seibold A, Ells S, Schlaeger C, Welsh Z. A meta-analysis of real-world observational studies on the impact of flash glucose monitoring on glycemic control as measured by HbA1c. Poster presented at: 78th Scientific Sessions; June 2018; Orlando, FL. 3. FreeStyle Libre 14 day User's Manual. Indications and Important Safety Information FreeStyle Libre 14 day Flash Glucose Monitoring system is a 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 system is 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 system does not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The 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. FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care in various jurisdictions.
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