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FreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control*†1-3

CGM = continuous glucose monitoring

Both real-world evidence and clinical trial results highlight the benefits of FreeStyle Libre CGM systems*†1,2,4-9

Positive impact on glucose management*†8

Among adult FreeStyle Libre portfolio users*†8:

  • 95% report having a better understanding of their glucose fluctuations

  • 77% report less hypoglycemic episodes

  • 92% found it easier to manage meal-time glucose

  • 37% report engaging in physical activity more frequently 

Increased time in range (TIR) among app users‡10

Adult patients using the FreeStyle Libre app platform experienced 5% greater TIR compared with adult patients using readers‡10:

  • Less time in hyperglycemia

  • Lower average glucose

  • Lower glucose variability

Reduced A1c*†5,11

A1c reduction, even in adult Type 2 diabetes (T2D) patients*†5,11. In real-world studies, T2D patients with a high A1c at baseline (8% and above) experienced:

  • 0.9% A1c reduction within 3 to 6 months among patients treated with basal bolus insulin*†5

  • 1.5% A1c reduction at 6 months in patients with suboptimal glycemic control who were treated with nonintensive therapy11

Reduced time in hypoglycemia (<70 mg/dL)*†1,2

  • 38%12 less time in hypoglycemia vs. BGM (122 mins vs. 196 mins)12 among adult patients with T1D (n=120)*†§2

  • 41%12 less time in hypoglycemia vs. BGM (35 mins vs. 59 mins)12 among adult patients with T2D (n=75)*†II1

Reduced hospitalizations*†¶8,12

  • 66% of adult patients experienced a reduction in hospital admissions, from 13.7% to 4.7% at 12 months (p<0.001)*†¶12

Reduced work absenteeism*†¶8

  • 58%12 of adult patients experienced a reduction in work absenteeism, from 18.5% to 7.7% at 12 months (p<0.05)*†¶8

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 the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month. Medicare and other third party payor criteria apply. 

At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.

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 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.

‡ Data from this study was collected with the FreeStyle Libre 14 day system and FreeStyle LibreLink. 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.

§ IMPACT Trial: A randomized, controlled 6-month trial to evaluate the effectiveness of the FreeStyle Libre glucose monitoring system (n=119) on glycemic control for the self-management of T1D as compared to SMBG (n=120).

II REPLACE Trial: A randomized, controlled trial to evaluate the impact of FreeStyle Libre glucose monitoring system (n=149) on HbA1c in patients with T2D taking multiple doses of insulin at 6 months compared to SMBG (n=75).

¶ FLARE Study: A real-world study of the effect of FreeStyle Libre system on 1365 T1D and T2D patients on insulin over 1 year: endpoints included A1c, hypoglycemia, and patient-reported outcomes.

References: 1. 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. 2. 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. 
3. 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. 4. 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. 5. 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. 6. 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. 7. 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 (2018): 37-46. https://doi.org/10.1016/j.diabres.2017.12.015. 
8. 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 & Care 7, no. 1 (2019): e000809. https://doi.org/10.1136/bmjdrc-2019-000809. 9. Charleer, Sara et al. “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. doi:10.2337/dc19-1610. 10. Kao, Kalvin, et al. "Comparison of glucose metrics between users of CGM readers and CGM-connected apps." Journal of Diabetes Science and Technology (2021). https://doi.org/10.1177/19322968211044141. 11. Wright, Eugene E., et al. "Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy." Diabetes Spectrum (2021): ds200069. https://doi.org/10.2337/ds20-0069. 12. Data on File. Abbott Diabetes Care.

ADC-42746 v2.0 11/22

Important Safety Information

FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855‑632‑8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.

IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.

CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for 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. Review all product information before use or contact Abbott Toll Free (855-632-5297) (or visit provider.myfreestyle.com) for detailed indications for use and safety information.

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This website and the information contained herein is intended for use by residents of the United States.

ADC-45115 v6.0 12/22