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The Libre 2, a continuous glucose monitoring (CGM) system developed by Abbott, received FDA approval on June 15, 2020, for use in adults and children aged 4 and older. On August 2, 2021, the app was approved allowing users to monitor their glucose levels more conveniently through their smartphones.

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Key Features

·         Continuous glucose monitoring through interstitial fluid

·         Small sensor worn on back of arm

·         Uses Bluetooth through cell phone or reader

·         Data management of glucose levels in charts and graphs

·         Ability to set alarms for high or low glucose

·         Can share glucose data with healthcare team

·         No need for fingersticks

·         Improved compliance and control of diabetes

·         Aids healthcare professionals to see if treatment plan is working

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"Abbott's world's leading¹ and affordable2 integrated continuous glucose monitoring (iCGM) sensors are cleared for connectivity with automated insulin delivery (AID) systems in the U.S.

Sensors also cleared for use by children as young as two years old, for use by women with diabetes who are pregnant, and for wear time up to 15 days," Abbott, 2023.

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Abbott Diabetes Care

855.632.8658

ADC_Public_Affairs@abbott.com

https://www.freestyle.abbott/us-en/home.html

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FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes age 4 and older.

Medicare coverage is available for FreeStyle Libre systems if their respective readers are used to review glucose data on some days every month. Medicare and other third-party payor criteria apply.

Abbott provides this information as a courtesy, it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.

* Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore the study data is applicable to both products.

† Based on prescription claims for commercially insured patients starting on the FreeStyle Libre personal CGM systems compared to competitor CGMs. Does not include Medicare, Medicaid, uninsured, and other federal or state healthcare program patients. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.

‡ Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.

§ Data from this study was collected with the US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 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.

ǁ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 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.

¶ 60-minute warm-up required when starting the sensor.

# 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.

** 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.

†† The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app.

‡‡ The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.

§§ In comparison to the FreeStyle Libre 2 reader.

ǁǁ The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.

¶¶ The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.librelinkup.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView. LibreLinkUp is not intended to be used for dosing decisions. The user should follow instructions on the continuous glucose monitoring system. LibreLinkUp is not intended to replace self-monitoring practices as advised by a physician.

## The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

*** Based on a comparison of list prices of the FreeStyle Libre personal CGM systems versus competitors' CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.

††† Participating pharmacies are subject to change without notice. Product availability may vary by retailer.

‡‡‡ Glucose readings are not available during 1-hour warm-up, when sensor is too hot or too cold, or when you see an error, "LO" or "HI" message, or no current glucose reading.

References: 1. Campbell, Fiona M., et al. "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. https://doi.org/10.1111/pedi.12735. 2. 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 Multicentre, Open-label Randomised Controlled Trial." Diabetes Therapy 8, no. 1 (2017): 55-73. https://doi.org/10.1007/s13300-016-0223-6. 3. FreeStyle Libre 3 User's Manual. 4. Data on File. Abbott Diabetes Care. 5. Unger, Jeff, Pamela Kushner, and John E. Anderson. "Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care." Postgraduate Medicine 132, no. 4 (2020): 305-313. https://doi.org/10.1080/00325481.2020.1744393. 6. Evans, Mark, et al. "Reductions in HbA1c with flash glucose monitoring are sustained for up to 24 months: a meta analysis of 75 real-world observational studies." Diabetes Therapy (2022). https://doi.org/10.1007/s13300-022-01253-9. 7. Bolinder, Jan, et al. "Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial." The Lancet 10057, no. 388 (2016): 2254-2263. https://doi.org/10.1016/S0140-6736(16)31535-5. 8. Yaron, Marianna, 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. https://doi.org/10.2337/dc18-0166. 9. FreeStyle Libre 2 User's Manual. 10. FreeStyle Libre 14 User's Manual.

ADC-42700 v8.0

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FreeStyle Libre Systems (CGM) | Healthcare Providers

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View information for healthcare providers about the FreeStyle Libre systems for continuous glucose monitoring (CGM). See efficacy data, cost information, product details, comparisons, and resources for you and your patients.

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How to Apply the FreeStyle Libre 14 Day Sensor

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No Finger Sticks

Data Management

24 hr Monitoring

14 days per Sensor

Share Information with providers

Alerts/Alarms

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Sensors Fall Off before 14 days

Cost

Need for a prescription

Need patches to over sensors

Need to have a reader or cellphone nearby

Can cause skin irritation

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Personal Experience

My husband is a diabetic and refused to check his sugars. I got him the free FreeStyle to try and it was life changing. He says he does not feel the insertion of the sensor. The system is easy to use. We set up alarms for lows and highs. Set target range. When we started with his first FreeStyle his A1C was 9.6. After watching his trends and medication adjustments, current A1C is 6.8. This was about a year of work. He says in target most of the day. I love the feature that you can see glucose levels over 90 days in a line or graph chart. It also will break it down by time.

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With the ease of use, little to no risks, and increase compliance with glucose control I see no reason not to use the FreeStyle Libre 2. I do wish more insurance companies paid for them and that when they do the ordering was easier. But once you get through those hoops its easy.

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Analytical

Adaptability

Positivity

Achiever

Competition

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Leadership strengths such as analytical, adaptability, positivity, achiever, and competition can significantly enhance team performance. An analytical leader helps the team make informed decisions by carefully evaluating data and options. Adaptability ensures the team remains flexible and resilient in the face of change, quickly adjusting strategies as needed. Positivity fosters a supportive and encouraging environment, boosting team morale and cohesion. An achiever's drive for excellence motivates the team to set and reach ambitious goals, while a competitive spirit encourages healthy rivalry and continuous improvement, pushing everyone to perform at their best. Together, these strengths create a dynamic and effective team capable of overcoming challenges and achieving success.

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Adding a team member who's strength is organizing will keep the team on track and minimize time spent looking for information.

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Having a strong communicator helps facilitate relationships outside to team to help promote the project.

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The developer of the team promotes potential in others. Encouraging all team members to be at their highest functioning.

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Team member Isaac brings a love of ideas and works to find connections among the ideas. A great help when a team has many ideas and are struggling to find a common core.

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William is Mister Personality. Never meets a stranger and has the ability to share your team ideas with others. This helps build outside relationships with other teams.

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U.S. Food and Drug Administration. (2017, September 27). FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-continuous-glucose-monitoring-system-adults-not-requiring-blood-sample

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PR Newswire. (2023, February 27). US FDA clears Abbott’s FreeStyle Libre 2 and FreeStyle Libre 3 sensors for integration with automated insulin delivery systems. PR Newswire. https://www.prnewswire.com/news-releases/us-fda-clears-abbotts-freestyle-libre-2-and-freestyle-libre-3-sensors-for-integration-with-automated-insulin-delivery-systems-301763020.html

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Abbott. (n.d.). FreeStyle Provider. Abbott. https://www.freestyleprovider.abbott/us-en/home.html