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References

References:

† Data on File. Abbott Diabetes Care.

‡ 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.

∆ Terms and conditions apply. Check your eligibility here.

Abbreviations: HbA1c/A1: glycated haemoglobin; BGM: blood glucose monitoring; CGM: continuous glucose monitoring; HCP: health care professional; hypo: hypoglycaemic event; ISF: interstitial fluid; MDI: multiple daily injections; RCT: randomised controlled trial; SMBG: self-monitoring of blood glucose; TIR: time in range; T1D: type 1 diabetes; T2D: type 2 diabetes.

± Work with your healthcare professional to understand your glucose history.

* Scanning the sensor to obtain glucose values does not require lancets. To get a 24-hour glycaemic picture, users need to scan at least once every 8 hours

** Sensor is water resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.

§ Sensor dimensions: 35mm x 5mm Weight: 5 grams.

# The FreeStyle Libre reader can capture data from within 1cm to 4cm of the sensor, even through clothing.

ф Most people did not feel any discomfort under the skin while wearing the FreeStyle Libre sensor. In a study conducted by Abbott Diabetes Care, 93.4% of patients surveyed (n=30) strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin. [29 persons have finished the study; 1 person terminated the study after 3 days due to skin irritations in the area where the sensor touched the skin].

†† Finger pricks are required if glucose readings and alarms do not match symptoms or expectations.

^ Based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use sensor-based glucose monitoring systems.

  1. Ajjan R, et al. Continuous Glucose Monitoring: A Brief Review for Primary Care Practitioners. Adv Ther 2019;36:579-596. https://doi.org/10.1007/s12325-019-0870-x.
  2. Alva S, et al. Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes. J Diabetes Sci Technol 2020. https://doi.org/10.1177/1932296820958754.
  3. American Diabetes Association. Standards of medical care in diabetes—2020. Diabetes Care. 2020;43(1):S77-S88.
  4. Battelino T, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019. https://doi.org/10.2337/dci19-0028.
  5. Beck RW, et al. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials. Diabetes Care 2019;42(3):400–405. https://doi.org/10.2337/dc18-1444.
  6. Bolinder J, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263.
  7. Brixner D, et al. Clinical and Economic Outcomes of Patients with Type 2 Diabetes on Multiple Daily Injections of Basal-bolus Insulin (MDI) Therapy: A Retrospective Cohort Study. Clinical Therapeutics 2019;41(2):303-313. doi: 10.1016/j.clinthera.2018.12.014.
  8. Carlson AL, et al. Flash glucose monitoring in type 2 diabetes managed with basal insulin in the USA: a retrospective real-world chart review study and meta-analysis. BMJ Open Diab Res Care. 2022. https://doi.org/10.1136/bmjdrc-2021-002590.
  9. Cengiz E, and Tamborlane WV. A tale of two compartments: interstitial versus blood glucose monitoring. Diabetes Technol Ther. 2009;11 Suppl 1(Suppl 1):S11-S16. doi:10.1089/dia.2009.0002.
  10. Charleer S, 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 2020;43(2):389-397. https://doi.org/10.2337/dc19-1610.
  11. Evans M, 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 Ther 2020;11:83-95. https://doi.org/10.1007/s13300-019-00720-0.
  12. Evans M, 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 Ther 2022. https://doi.org/10.1007/s13300-022-01253-9.
  13. Fokkert M, 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 2019;7:e000809. doi: 10.1136/bmjdrc-2019-000809.
  14. Foster NC, et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018. Diabetes Technol Ther 2019;21(2):66-72. https://doi.org/10.1089/dia.2018.0384.
  15. FreeStyle Libre 2 User Manual (EU).
  16. Garden GL, et al. HbA1c and hypoglycaemia outcomes for people with type 1 diabetes due to the introduction of a single-day structured education programme and flash glucose monitoring. Br J Diabetes 2021;21:84-88. https://doi.org/10.15277/bjd.2021.284.
  17. Haak T, et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes. Diabetes Ther. 2016. doi: 10.1007/s13300-016-0223- 6.
  18. Hirst JA, et al. Quantifying the effect of metformin treatment and dose on glycemic control. Diabetes Care. 2012 Feb;35(2):446-54. doi: 10.2337/dc11-1465.
  19. Lang J, et al. Expanded Real-World Use Reaffirms Strong Correlation between Scanning Frequency of Flash Glucose Monitoring and Glucose Control. Diabetes 1 June 2019; 68 (Supplement_1): 972–P. https://doi.org/10.2337/db19-972-P.
  20. Lee WC, et al. Frequency of blood glucose testing among insulin-treated diabetes mellitus patients in the United Kingdom. J Med Econ. 2014 Mar;17(3):167-75. doi: 10.3111/13696998.2013.873722.
  21. Miller E, Brandner L, Wright E. HbA1c reduction after initiation of the FreeStyle Libre system in type 2 diabetes patients on long-acting insulin or non-insulin therapy [84-LB]. Poster presented at: American Diabetes (ADA) 80th Scientific Sessions.
  22. Seibold AJ, Minimizing Adverse Skin Reactions to Wearable Continuous Glucose Monitoring Sensors in Patients With Diabetes. J Diabetes Sci Technol. 2021 May;15(3):713-714. doi: 10.1177/1932296820984763.
  23. Unger J, et al. Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care. Postgrad Med. 2020 May;132(4):305-313. doi: 10.1080/00325481.2020.1744393.
  24. Vigersky RA, et al. The Relationship of Hemoglobin A1C to Time-in-Range in Patients with Diabetes. Diabetes Technol Ther. 2019 Feb;21(2):81-85. doi: 10.1089/dia.2018.0310.
  25. Vincze G, et al. Factors Associated With Adherence to Self-Monitoring of Blood Glucose Among Persons With Diabetes. Diabetes Educ 2004;30(1):112-125. doi:10.1177/014572170403000119.
  26. Wagner J, et al. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther. 2005 Aug;7(4):612-9. doi: 10.1089/dia.2005.7.612.
  27. Wright E, et al. Diabetes Spectrum. Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy. 2021;34(2):184–189. https://doi.org/10.2337/ds20-0069.
  28. Yaron M, et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166.
  29. Nuha A. ElSayed, et al. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes: Standards of Care in Diabetes—2023. Diabetes Care. Jan 2023; 46 (Supplement_1): S68–S96.
  30. National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes Diet, Eating, & Physical Activity. 2016. Accessed 25 Aug 2022. Available at: https://www.niddk.nih.gov/health-information/diabetes/overview/diet-eating-physical-activity.
  31. Joseph JJ, Golden SH. Cortisol dysregulation: the bidirectional link between stress, depression, and type 2 diabetes mellitus. Ann N Y Acad Sci. 2017 Mar;1391(1):20-34.
  32. van Duinkerken E, Snoek FJ, de Wit M. The cognitive and psychological effects of living with type 1 diabetes: a narrative review. Diabet Med. 2020 Apr;37(4):555-563.
  33. Bailey T, et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technology & Therapeutics. 2015;17(11):787-794
  34. Ministry of Health Malaysia. Diabetic Meal Plan. 2013. Accessed 18 April 2023. Available at: http://pendidikanpesakit.myhealth.gov.my/en/diabetic-meal-plan/.
  35. Centers for Disease Control and Prevention. Manage Blood Sugar. Accessed 20 May 2023. Available at: https://www.cdc.gov/diabetes/managing/manage-blood-sugar.html.
  36. American Diabetes Association. Better blood glucose meters and more. Accessed 20 May 2023. Available at: https://diabetes.org/tools-support/devices-technology.
  37. Centers for Disease Control and Prevention. Diabetes Risk Factors. Accessed 20 May 2023. Available at: https://www.cdc.gov/diabetes/basics/risk-factors.html.
  38. Bays HE, et al. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61(5):737–47.
  39. Diabetes Self-Management. ABCs of Diabetes. Accessed 3 July 2023. Available at: https://www.diabetesselfmanagement.com/managing-diabetes/complications-prevention/taking-diabetes-to-heart/abcs-of-diabetes/.
  40. National Institute of Diabetes and Digestive and Kidney Diseases. Type 2 Diabetes. Accessed 3 July 2023. Available at: https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes.
The FreeStyle Libre flash glucose monitoring system is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus. The indication for children (age 4 – 17) is limited to those who are supervised by a caregiver at least 18 years old who is responsible for supervising, managing, and assisting the child in using the FreeStyle Libre system and interpreting its readings. Health care professionals and consumers should be aware about the limitations of available scientific evidence for use of this device in any other groups of patients who require diabetes management. Always read the label and use as directed. Registered under Act 737 – Reg. No: GC47794107716. MDAMD 0232/2024
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