![[PDF]](/pb-assets/Icons/adobe-pdf-icon-1498649896243.png){kind=icon}
Abstract
Background:
In this study, we evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre Flash Glucose Monitoring (FreeStyle Libre 2) System compared to plasma venous blood glucose reference, Yellow Springs Instrument 2300 (YSI).
Methods:
The study enrolled participants aged four and above with type 1 or type 2 diabetes at seven sites in the United States. Adult participants (18+ years) participated in three in-clinic sessions and pediatric participants (4-17 years) participated in up to two in-clinic sessions stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13, or 14 of sensor wear. Participants aged 11+ underwent supervised glycemic manipulation during in-clinic sessions to achieve glucose levels across the measurement range of the System. Performance evaluation included accuracy measures such as the proportion of continuous glucose monitoring (CGM) values that were within ±20% or ±20 mg/dL of reference glucose values, and bias measures such as the mean absolute relative difference (MARD) between CGM and reference values.
Results:
Data from the 144 adults and 129 pediatric participants were analyzed. Percent of sensor results within ±20%/20 mg/dL of YSI reference were 93.2% and 92.1%, and MARD was 9.2% and 9.7% for the adults and pediatric participants, respectively. The System performed well in the hypoglycemic range, with 94.3% of the results for the adult population and 96.1% of the data for pediatric population being within 15 mg/dL of the YSI reference. The time lag was 2.4 ± 4.6 minutes for adults and 2.1 ± 5.0 minutes for pediatrics.
References
| 1. |
Abbott . Abbott Receives CE Mark for FreeStyle® Libre, A Revolutionary Glucose Monitoring System for People with Diabetes. Abbott Park, IL: Abbott; 2014. Google Scholar |
| 2. |
Bailey, T, Bode, BW, Christiansen, MP, Klaff, LJ, Alva, S. The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther. 2015;17(11):787-794. Google Scholar | Crossref | Medline | ISI |
| 3. |
Fokkert, MJ, van Dijk, PR, Edens, MA, et al. Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017;5(1):e000320. Google Scholar | Crossref | Medline |
| 4. |
Hoss, U, Budiman, ES, Liu, H, Christiansen, MP. Feasibility of factory calibration for subcutaneous glucose sensors in subjects with diabetes. J Diabetes Sci Technol. 2014;8(1):89-94. Google Scholar | SAGE Journals |
| 5. |
Hoss, U, Budiman, ES. Factory-calibrated continuous glucose sensors: the science behind the technology. Diabetes Technol Ther. 2017;19(suppl 2):S44-S50. Google Scholar | Crossref | Medline |
| 6. |
Forlenza, GP, Kushner, T, Messer, LH, Wadwa, RP, Sankaranarayanan, S. Factory-calibrated continuous glucose monitoring: how and why it works, and the dangers of reuse beyond approved duration of wear. Diabetes Technol Ther. 2019;21(4):222-229. Google Scholar | Crossref | Medline |
| 7. |
Forlenza, GP, Argento, NB, Laffel, LM. Practical considerations on the use of continuous glucose monitoring in pediatrics and older adults and nonadjunctive use. Diabetes Technol Ther. 2017;19(suppl 3):S13-S20. Google Scholar | Crossref |
| 8. |
Kudva, YC, Ahmann, AJ, Bergenstal, RM, et al. Approach to using trend arrows in the FreeStyle Libre flash glucose monitoring systems in adults. J Endocr Soc. 2018;2(12):1320-1337. Google Scholar | Crossref | Medline |
| 9. |
Bolinder, J, Antuna, R, Geelhoed-Duijvestijin, P, Kroger, J, Weitgasser, R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicenter, non-masked, randomized control trial. Lancet. 2016;388(10057):2254-2263. Google Scholar | Crossref | Medline | ISI |
| 10. |
Aleppo, G, Ruedy, KJ, Riddlesworth, TD, et al. REPLACE-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in adults with well-controlled type 1 diabetes. Diabetes Care. 2017;40(4):538-545. Google Scholar | Crossref | Medline | ISI |
| 11. |
Haak, T, Hanaire, H, Ajjan, R, Hermanns, N, Riveline, JP, Rayman, G. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Ther. 2017;8(1):55-73. Google Scholar | Crossref | Medline |
| 12. |
Beck, RW, Riddlesworth, TD, Ruedy, K, et al. Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med. 2017;167(6):365-374. Google Scholar | Crossref | Medline |
| 13. |
Foster, NC, Miller, KM, Tamborlane, WV, Bergenstal, RM, Beck, RW. Continuous glucose monitoring in patients with type 1 diabetes using insulin injections. Diabetes Care. 2016;39(6):e81-e82. Google Scholar | Crossref |
| 14. |
Miller, KM, Foster, NC, Beck, RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015;38(6):971-978. Google Scholar | Crossref | Medline | ISI |
| 15. |
Miller, KM, Hermann, J, Foster, N, et al. Longitudinal changes in continuous glucose monitoring use among individuals with type 1 diabetes: international comparison in the German and Austrian DPV and U.S. T1D exchange registries. Diabetes Care.2020 43(1): e1-e2. Google Scholar | Crossref |
| 16. |
Carlson, AL, Mullen, DM, Bergenstal, RM. Clinical use of continuous glucose monitoring in adults with type 2 diabetes. Diabetes Technol Ther. 2017;19(suppl 2):S4-S11. Google Scholar | Crossref | Medline |
| 17. |
Park, C, Le, QA. The effectiveness of continuous glucose monitoring in patients with type 2 diabetes: a systematic review of literature and meta-analysis. Diabetes Technol Ther. 2018;20(9):613-621. Google Scholar | Crossref | Medline |
| 18. |
Abbott . Abbotts’S FreeStyle® Libre 2, with Optional Real-Time Alarms Secures CE Mark for Use in Europe. Abbott Park, IL: Abbott; 2018. Google Scholar |
| 19. |
Parkes, JL, Slatin, SL, Pardo, S, Ginsberg, BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23:1143-1148. Google Scholar | Crossref | Medline | ISI |
| 20. |
Abbott . New Real-World Data Show that Abbott’s FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes. Abbott Park, IL: Abbott; 2020. Google Scholar |
| 21. |
Shah, VN, Laffel, LM, Wadwa, RP, Garg, SK. Performance of a factory-calibrated real-time continuous glucose monitoring system utilizing an automated sensor applicator. Diabetes Technol Ther. 2018;20(6):428-433. Google Scholar | Crossref | Medline |
| 22. |
Wadwa, RP, Laffel, LM, Shah, VN, Garg, SK. Accuracy of a factory-calibrated, real-time continuous glucose monitoring system during 10 days of use in youth and adults with diabetes. Diabetes Technol Ther. 2018;20(6):395-402. Google Scholar | Crossref | Medline |
| 23. |
Jangam, S, Lang, J, Dunn, T, Xu, Y, Hayter, G. 298OR: Sustained improvement in glycemia following flash glucose monitoring: an expanded worldwide analysis. Diabetes. 2019;68(suppl 1): 298OR. https://doi.org/10.2337/db19-298-OR Google Scholar |
| 24. |
Shivers, JP, Mackowiak, L, Anhalt, H. “Turn it off!”: diabetes device alarm fatigue considerations for the present and the future. J Diabetes Sci Technol. 2013;7:789-794. Google Scholar | SAGE Journals |
