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References

References:

Data on File. Abbott Diabetes Care.

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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.

~ Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal use sensor based glucose monitoring systems.

§ 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.

  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. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. FreeStyle Libre 2 User Manual (EU).
  13. 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
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. Wright 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;34(2):184–189. https://doi.org/10.2337/ds20-0069.
  22. 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.
  23. Bailey Timothy., et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technology and Therapeutics. 2015; 17(11):787-794.
  24. Hoss et al. Feasibility of Factory Calibration for Subcutaneous Glucose sensors in Subjects with Diabetes, Journal of Diabetes Science and Technology 2014, Vol. 8(1) 89–94.
  25. Data on file: Abbott Diabetes Care. FreeStyle Optium Neo product monograph (ADC-46172).
  26. Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, user acceptability, and safety evaluation for the FreeStyle Libre flash glucose monitoring system when used by pregnant women with diabetes. Diabetes Technol Ther. 2018;20(3):180-188
  27. Campbell FM, et al. Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes. 2018 Nov;19(7):1294-1301. doi:10.1111/pedi.12735.
  28. 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.
  29. Centers for Disease Control and Prevention. Sleep for a Good Cause. 2022. Accessed 25 Aug 2022. Available at: https://www.cdc.gov/diabetes/library/features/diabetes-sleep.html.
  30. Rao PV, Makkar BM, Viswanathan. RSSDI consensus on self-monitoring of blood glucose in types 1 and 2 diabetes mellitus in India. International Journal of Diabetes in Developing Countries. 2018;38:260–279.
  31. Joshi SR. Glycemic Variability and Ambulatory Glucose Profi le in Indian Diabetics. JAPI. 2016
  32. Borgharkar SS, Das SS. Real-world evidence of glycemic control among patients with type 2 diabetes mellitus in India: the TIGHT study. BMJ Open Diab Res Care. 2019;7:e000654. doi:10.1136/bmjdrc-2019-000654

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