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The FreeStyle Libre is brought into practice by Abbott Healthcare who has been committed to helping people live their best possible life through the power of health. For more than 25 years they have brought new products and technologies to the world--in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. The FDA pproved the FreeStyle Libre 14 day Flash Monitoring system on July 27, 2018.

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Abbott.  July 27, 2018. Press release, retrieved from
https://abbott.mediaroom.com
Medgadget. February 2, 2019. retrieved from
https://www.medgadget.com
Centers for Disease Control and Prevention. National Diabetes Statistic Report 2017. Atlanta, GA: Centers for Disease Control and Prevention, US. Department of Health and Human Services, 2017. retrieved from
https://www.cdc.gov/diabetes/data/statistics/statistics-report.html on 2/11/2019

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-Painless scan provides real-time glucose readings for insulin dosing without the need for fingersticks
-Discreet sensor is easy to apply and comfortable to wear
-Now approved for up to 14 days.  Patients can exercise, shower, and swim in a depth of up to 1 meter for 30 minutes
-Continuously measures glucose every single minute and records readings every 15 minutes. Stores up to 8 hours of glucose data
-Helps patients track key factors impacting glucose throughout the day such as food, insulin, and exercise
-The only CGM able to maintain accuracy over 14 days without the need for fingerstick calibration or sensor coding
-Ability to use this device with an App on a smartphone to monitor and track glucose levels
-Most commercially insured patients will pay between $40 and $75 per month for sensors
FreeStyle LibrelLink app is free to download at the Apple App Store. Patients can see glucose results on their phone.

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The device is stuck to the back of the upper arm and a separate display device, which looks like a smartphone, is used to download readings from the sensor. The display device can share those readings with one’s medical team, as well as help the patient track glucose levels and correlate it with activity, diet, and insulin intake.

Because readings can be taken at any time and don’t require painful fingerpricks, patients are typically more willing to keep a close eye on their glucose. This can lead to a reduction of dangerous events, such as hypoglycemia, and result in better compliance with drugs, improved understanding of factors influencing one’s diabetes, and simply improve a patient’s quality of live.

The latest approval involves the longest time that a continuous glucose monitor can be used in a single stretch in the U.S

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-The sensor must be removed for testing such as MRI, CT scan, X-ray, or diathermy treatment
-Patients will have to check glucose using a fingerstick method when the check sensor readings appears or if readings are suspected to be inaccurate according to symptoms
-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
-The FreeStyle Libre System does not have alarms that will automatically notify you when there is a severe low or high glucose event, the patient would have to rely on symptoms
-The System is not approved for people less than 18 years of age and this population would be likely to want to try to use this device with an App for glucose monitoring
-The cost could be more than average for patients

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Deliberative
Consistency
Relator
Empathy
Harmony

MY TEAM
Fernando-Chosen for his ability to be the point person on the project.  He can take control and keep focus on what is needed to stay on track.

Faith-Chosen for the ability to be inspired by the future. The FreeStyle Libre is a device that appears to be for the tech savvy. There may be a need to market for people who want to manage their diabetes using an App.

Carter-As a strong communicator this will be useful when trying to make this new product fit into the lifestyles of many. Being able to engage easily in conversations and put the process in words easy to understand will be needed.

Angelica-Chosen to be able to think through all of the factors surrounding this new device and reason out a way to bring the device into the hands of people willing to give it a try.

Emily-Chosen for her ability to be able to empathize with this patient population and see how this new device could be useful in their lives.

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A total of 30.3 million people have diabetes, 9.4% of the US population. As an educator, I can see how the FreeStyle Libre would be beneficial for diabetic patients requiring strict glucose control resulting in frequent finger sticks each day. Using this new device wold allow patients to discreetly and safely monitor their glucose levels without the pain and inconvenience of finger sticks.