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14 day Continuous Glucose Monitor (CGM)

Wearable system that is placed on the back of the upper arm (size of two quarters)

CGM readings are taken from the interstitial fluid using a 0.4 mm sensor filament

Wearer holds smart phone or provided meter up to the sensor and glucose value is displayed painlessly

Data is automatically uploaded to the app and can be trended

Approved for use by the US FDA in September of 2017

(Hastings, 2019)

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The FreeStyle Libre 14 day Flash Glucose Monitoring System is indicated for the management of diabetes in persons aged 18 and older.

FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes ages 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.

Abbott supports patient access to the FreeStyle Libre family of products through a variety of programs, including trial offers, that may reduce the out-of-pocket amounts that patients must pay. The actual amount that a patient may pay may vary or change based on factors such as the duration of the program, product insurance coverage status, state of residence, or other eligibility limitations. Abbott may modify, rescind, or revoke these programs at any time without notice.

* Data from this study was collected with the outside US version of 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.

† 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.

‡ FreeStyle Libre 2 and 3 systems: 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.

§ 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.

ǁ Data based total active Medicare patients with CGM readers.

¶ Patients must meet Medicare eligibility coverage criteria.

# or ♢ Eligible patients will receive one (1) FreeStyle Libre 2 sensor or (1) FreeStyle Libre 3 sensor for users with a compatible mobile phone operating system at $0 copay. The expiration date of the voucher is 60 days from the issue date. This program is available for patients with Type 1, Type 2, or gestational diabetes. Patients ages 18 and older are eligible to sign up and receive an offer for the (1) FreeStyle Libre 2 sensor or (1) FreeStyle Libre 3 sensor. Patients ages 4-17 are eligible to receive an offer for the (1) FreeStyle Libre 2 sensor or (1) FreeStyle Libre 3 sensor through their parent or guardian. This offer is void where prohibited by law. Abbott may modify or rescind this offer at any time without notice. The discounts are not available to beneficiaries of Kaiser Permanente, Medicare, Medicaid or other federal or state healthcare programs, residents of Massachusetts, or US territories (other than Puerto Rico). The free (1) FreeStyle Libre 2 sensor or (1) FreeStyle Libre 3 sensor is provided as a sample and is limited to one sample per eligible person per product identification number. The FreeStyle Libre 2 sensor or FreeStyle Libre 3 sensor cannot be re-sold, traded nor submitted to any third-party payer for reimbursement and is not provided as any inducement for future purchases. The free sample card is not health insurance.

** Based on the sensor being replaced once every 14 days, and scanned at least once every 8 hours. The FreeStyle Libre 3 system does not require scanning.

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

‡‡ 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.

§§ 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.

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

¶¶ The FreeStyle LibreLink 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 LibreLink app requires registration with LibreView.

## 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 FreeStyle Libre 3 app is designed to facilitate data sharing between patients and their healthcare providers and caregivers.

††† The FreeStyle Libre 2 app and the FreeStyle Libre 2 reader have similar but not identical features. Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.

‡‡‡ The FreeStyle Libre 3 app and the FreeStyle Libre 3 reader have similar but not identical features. Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.

§§§ The FreeStyle LibreLink app and the FreeStyle Libre 14 day reader have similar but not identical features. 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.

References: 1. Fokkert, Marion, et al. "Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)." BMJ Open Diabetes Research and Care 7 (2019): e000809. https://doi.org/10.1136/bmjdrc-2019-000809. 2. Data on File. Abbott Diabetes Care. 3. Local Coverage Determination (LCD) L33822, Glucose Monitors, https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33822. 4. FreeStyle Libre 2 User's Manual. 5. FreeStyle Libre 3 User's Manual. 6. FreeStyle Libre 14 day User's Manual. 7. 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. 8. Bolinder, Jan, et al. "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. https://doi.org/10.1016/S0140-6736(16)31535-5. 9. 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. 10. Evans, Mark, et al. "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. https://doi.org/10.1007/s13300-019-00720-0. 11. Kroeger, Jens, Peter Fasching, and Helene Hanaire. "Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes." Diabetes Therapy 11, no. 1 (2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9. 12. Dunn, Timothy C., et al. "Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycemic measures: A European analysis of over 60 million glucose tests." Diabetes Research and Clinical Practice 137, no. 37 (2018): 37-46. https://doi.org/10.1016/j.diabres.2017.12.015. 13. 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. 14. Bolinder, Jan, et al. "Comparison of Flash Glucose Monitoring Usage Patterns and Glycaemic Outcomes in the Real-World with Those Observed in a Randomized Controlled Trial." Diabetes Technology & Therapeutics 20, no. S1 (2018). https://doi.org/10.1089/dia.2018.2525.abstracts. 15. 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.

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FreeStyle Libre Continuous Glucose Monitoring | FreeStyle Libre US

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Know where your glucose is headed with the FreeStyle Libre 2 system, no fingersticks needed. Learn more about the FreeStyle Libre family of products for CGM and how to start your free trial (see eligibility).

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1. Smallest and longest lasting self-applied sensor available

2. Moves away from the traditional finger-stick method of blood glucose monitoring

3. Less painful and less invasive

4. Can be used with smart phone or purchased meter

5. Scanning for glucose is painless and application is minimally painful

6. Allows for monitoring of trends of glucose measurements

7. Provides information within one to three seconds

8. Waterproof

9. Improved compliance with health plan of care

10. More data for clinician assessment can be shared via different methods

11. Previous monitors required bulkier equipment

12. Low cost compared to other CGMs

13. Decreases fear and anxiety of hypo and hyperglycemia

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1. Requires a device that is worn on the body

2. Only site allowed is the back of the upper arm

3. Could potentially be inaccurate or defective, requiring finger stick

4. Does not have any alarms or alerts

5. Interstitial glucose readings can be about five to ten minutes behind blood glucose readings

6. Risk of allergic skin reaction

7. Not integrated with insulin pumps (pump still require programming for bolus insulin dose or stop basal rate)

8. May not be fully covered under insurance

9. Each CGM can cost between $35 to 100 (lasting 14 days), which can be more expensive than blood glucose finger-stick

10. May lose adhesiveness and come off

11. Contraindicated during MRI, CT, X-ray, or diathermy

12. Not approved for pregnant women, people receiving dialysis, critically ill, or children (younger than 18)

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More than 425 million people live with diabetes around the world. This innovative technology makes diabetes more manageable. People with diabetes may have comorbidities that require multiple treatments, by simplifying diabetes treatment, compliance and health can improve. According to studies, this is a safe and beneficial alternative to traditional methods.
Type 1 Diabetes
Oskarsson, et al., (2018) reported markedly reduced hypoglycemic events, including during the nighttime hours. A con with this system is that it is not approved for the high prevalence population of children. More research should be done to make this safe for children.
The CGM should be integrated with insulin pumps. According to Hastings (2019), partnerships with other companies are being forged to make these products integrative.
Type 2 Diabetes
Haak, et al., (2017) reported sustained significant reduction of blood glucose and hemoglobin A1C, and a safe and effective replacement for finger-stick blood glucose monitoring for all ages.
Overall
Patients in both studies scanned sensors 13 to 18 times per day. Compliance with blood glucose monitoring is much higher compared to traditional methods of finger stick. More continuous data can allow for better intervention and management of diabetes. Both studies show that is a safe and effective alternative to traditional methods for patients with diabetes.

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IMPACT Randomized Control Trial (RCT)

Authors with Departments of Medicine and Diabetes

Type 1 Diabetics and CGM effect on hypoglycemic episodes

Reference
Oskarsson, P., Antuna, R., Geelhoed-Duijvestijn, P., Krӧger, J., Weitgasser, R., & Bolinder, J. (2018). Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: A pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia, 61(3), 539-550.

REPLACEMENT RCT

Authors are with Different universities in Department of Endocrinology and Diabetes

Study on Type 2 Diabetes that required insulin treatment

Reference
Haak, T., Hanaire, H., Ajjan, R., Hermanns, N., Riveline, J., & Rayman, G. (2017). Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Therapy, 8(3), 573-586. doi: 10.1007/s13300-017-0255-6

Interview with Abbott

Interviewer: Conn Hastings, PhD from the Royal College of Surgeons and became a full-time science writer and editor.

Interviewee: Chris Thomas is the Director for Biosensing Technology at Abbott.

Article published on Sept. 20, 2019 to Medgadget a credible source for reporting the latest in medical technologies.

Bias may be seen with Abbott promotion of product, but RCT's regarding the impact and replacement were cited.

Reference

Hastings, C. (2019). FreeStyle Libre 14 day System: Interview with Chris Thomas, Director of Biosensing Technology, Abbott. Exclusive Medicine. Retrieved from Medgadget.com

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My top 5 Strengths include: Achiever, Learner, Positivity, Strategic, Relator

I take satisfaction from feeling productive, I have a strong work ethic and I have the will and desire to learn

Faith: Futuristic

Inspirational

Creative ideas for the future

Fernando: Focus

Able to take direction

Able to prioritize and follow through

Abraham: Analytical

Ability to see all factors that influence a situation

Pablo: Positivity

Brings encouragement and energy to the team

Sheila: Strategic

Good judgement to recognize patterns

Assist with decision making

I chose this group because the strengths meld together to create a diverse and cohesive team. When implementing the CGM into a healthcare facility multiple factors must be considered. I can guide the team to create objectives, and work through the problems and cons of the system. I can consult with Sheila and Abraham on the plan to introduce and implement the product to discuss potential influencing factors. I can count on Fernando to take direction and help prioritize what is most important in order to complete the project. Pablo will help encourage the team through struggles, and Faith will be there when we have run out of ideas and we need a creative mind for planning.