Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study
Volume 4, Issue 4, December 2018, Pages: 32-36
Received: Nov. 13, 2018;
Accepted: Dec. 14, 2018;
Published: Jan. 14, 2019
Views 632 Downloads 86
Sayaka Ida, Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Hiroyuki Goto, Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Satoshi Ida, Department of Diabetes and Metabolism, Japan Red Cross Society Ise Red Cross Hospital, Ise, Japan
Maiko Watanabe, Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Masaya Okuda, Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Tetsushiro Takeuchi, Department of Cardiovascular Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Takashi Murata, Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Tsuyoshi Tanaka, Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan
Objective: This study aimed to examine the accuracy of FreeStyle Libre Pro, a factory calibrated retrospective continuous glucose monitoring (CGM) device, and compare its measurements to those by iPro2, a conventionally calibrated retrospective CGM device. Methods: FreeStyle Libre Pro and iPro2 were simultaneously used in 15 patients with type 2 diabetes mellitus. As these devices have different sensor duration, data from the initial 168 hours period were used. Finger prick glucose tests were performed using a conventional glucose meter, OneTouch UltraVue. The mean absolute relative difference (MARD) and mean absolute difference (MAD) of FreeStyle Libre Pro compared to conventional finger prick blood glucose tests were calculated. Furthermore, the paired glucose measurements obtained by FreeStyle Libre Pro and iPro2 were compared. Results: Overall MARD of FreeStyle Libre Pro was 17.4%, and, when limited to range ≥ 100 mg/dl, MARD was 16.8%. Overall MAD of FreeStyle Libre Pro was 32.0 mg/dl, and, when limited to range < 100 mg/dl, MAD was 21.1 mg/dl. Mean glucose measurements obtained by FreeStyle Libre Pro were significantly lower than those obtained by iPro2 (151.3±60.4 mg/dl vs. 179.4±64.1 mg/dl, P < 0.01). Linear regression analysis revealed significant correlation between glucose measurements obtained by FreeStyle Libre Pro and those obtained by iPro2: Glucose (FreeStyle Libre Pro) (mg/dl) = 0.86 × Glucose (iPro2) - 3.31 (mg/dl), r = 0.914, P < 0.01. Conclusions: FreeStyle Libre Pro is convenient to use because it does not need calibration by finger prick glucose tests, however our results supports the importance of confirming the measurements of FreeStyle Libre Pro by conventional finger prick glucose tests or central laboratory tests.
Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study, Biomedical Sciences.
Vol. 4, No. 4,
2018, pp. 32-36.
I. B. Hirsch, “Glycemic variability and diabetes complications: Does it matter? Of course it does!,” Diabetes Care, Vol. 38 (8), pp. 1610-1614, August 2015.
M. K. Rutter, “Devoting attention to glucose variability and hypoglycaemia in type 2 diabetes,” Diabetologia, Vol. 61 (1), pp. 43-47, January 2018.
Y. W. Pai, C. H. Lin, I. T. Lee and M. H. Chang, “Variability of fasting plasma glucose and the risk of painful diabetic peripheral neuropathy in patients with type 2 diabetes,” Diabetes Metab, Vol. 44 (2), pp. 129-134. March 2018.
J. Sato, T. Hirose and H. Watada, “Continuous glucose monitoring system: Is it really accurate, safe and clinically useful?,” J Diabetes Investig, Vol. 3 (3), pp. 225-230, June 2012.
U. Hoss and E. S. Budiman, “Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology,” Diabetes Technol Ther, Vol. 19 (S2), pp. S44-S50, May 2017.
T. Murata, S. Nirengi, Y. Kawaguchi, S. Sukino, T. Watanabe, and N. Sakane, “Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study,” Biomedical Sciences, Vol. 3 (6), pp. 109-113, October 2017.
T. Sato, H. Oshima, K. Nakata, Y. Kimura, T. Yano, M. Furuhashi, M. Tannno, T. Miki and T. Miura, "Accuracy of flush glucose monitoring in insulin-treated patients with type 2 diabetes," J Diabetes Investig, doi: 10.1111/jdi.12954, October 2018. [Epub ahead of print].
T. Bailey, B. W. Bode, M. P. Christiansen, L. J. Klaff and S. Alva, “The performance and usability of a factory-calibrated flash glucose monitoring system,” Diabetes Technol Ther, Vol. 17 (11), pp. 787-794, November 2015.
M. J. Fokkert, P. R. van Dijk, M. A. Edens, S. Abbes, D. de Jong, R. J. Slinqerland and H. J. Bilo, “Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus,” BMJ Open Diabetes Res Care, Vol. 5(1), pp. e000320, February 2017.
A. F. Olafsdottir, S. Attvall, U. Sandgren, S. Dahlqvist, A. Pivodic, S. Skrtic, E. Theodorsson and M. Lind, “A clinical trial of the accuracy and treatment experience of the flash glucose monitor FreeStyle Libre in adults with type 1 diabetes,” Diabetes Technol Ther, Vol. 19 (11), pp. 164-172, March 2017.
L. Ji, X. Guo, L. Guo, Q. Ren, N. Yu and J. Zhang, “A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes,” J Diabetes Sci Technol, Vol. 11 (2), pp. 290-295, March 2017.
S. Charleer, C. Mathieu, F. Nobels and P. Gillard, “Accuracy and precision of flash glucose monitoring sensors inserted into the abdomen and upper thigh compared with the upper arm,” Diabetes Obes Metab, Vol. 20 (6), pp. 1503-1507, June 2018.
C. Piona, K. Dovc, G. Y. Mutlu, K. Grad, P. Gregorc, T. Battelino and N. Bratina, “Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study,” Pediatr Diabetes, Vol. 19 (7), pp. 1285-1293, November 2018.
B. Bonora, A. Maran, S. Ciciliot, A. Avogaro and G. P. Fadini, “Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes,” J Endocrinol Invest, Vol. 39 (12), pp. 1391-1399, June 2016.
US Food and Drug Administration. PMA P150021: FDA Summary of Safety and Effectiveness Data. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150021B.pdf (last visited date: November 24th, 2018).
US Food and Drug Administration. FDA News Release. FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm (last visited date: November 24th, 2018).
T. Murata, N. Sakane, K. Kato, A. Tone and M. Toyoda, “The current intermittent-scanning CGM device situation in Japan: only adjunctive use to SMBG is approved and the latest health insurance coverage details,” J Diabetes Sci Technol, Vol. 12(3), pp. 729-730, May 2018.
US Food and Drug Administration. FDA News Release. FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602870.htm (last visited date: November 24th, 2018).
Dexcom, Inc., Dexcom G6 Continuous Glucose Monitoring System User Guide. https://s3-us-west-2.amazonaws.com/dexcompdf/G6-CGM-Users-Guide.pdf?_ga=2.100251803.427900143.1543031570-225005849.1543031570 (last visited date: November 24th, 2018).
D Price and T Walker, ”The Rationale for Continuous Glucose Monitoring-based Diabetes Treatment Decisions and Non-adjunctive Continuous Glucose Monitoring Use,” Eur Endocrinol, Vol. 12(1), pp. 24-30, March 2016.