Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study

Sayaka Ida; Hiroyuki Goto; Satoshi Ida; Maiko Watanabe; Masaya Okuda; Tetsushiro Takeuchi; Takashi Murata; Tsuyoshi Tanaka

doi:doi:10.11648/j.bs.20180404.11

Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study

Sayaka Ida, Hiroyuki Goto, Satoshi Ida, Maiko Watanabe, Masaya Okuda, Tetsushiro Takeuchi, Takashi Murata, Tsuyoshi Tanaka

Published in Biomedical Sciences (Volume 4, Issue 4)

Received: 13 November 2018 Accepted: 14 December 2018 Published: 14 January 2019

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Abstract

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.

Published in	Biomedical Sciences (Volume 4, Issue 4)
DOI	10.11648/j.bs.20180404.11
Page(s)	32-36
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

CGM, Accuracy, FreeStyle Libre Pro, IPro2, Type 2 Diabetes Mellitus

References

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[6]	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.
[7]	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].
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[12]	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.
[13]	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.
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APA Style

Sayaka Ida, Hiroyuki Goto, Satoshi Ida, Maiko Watanabe, Masaya Okuda, et al. (2019). Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomedical Sciences, 4(4), 32-36. https://doi.org/10.11648/j.bs.20180404.11

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ACS Style

Sayaka Ida; Hiroyuki Goto; Satoshi Ida; Maiko Watanabe; Masaya Okuda, et al. Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomed. Sci. 2019, 4(4), 32-36. doi: 10.11648/j.bs.20180404.11

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AMA Style

Sayaka Ida, Hiroyuki Goto, Satoshi Ida, Maiko Watanabe, Masaya Okuda, et al. Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomed Sci. 2019;4(4):32-36. doi: 10.11648/j.bs.20180404.11

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@article{10.11648/j.bs.20180404.11,
  author = {Sayaka Ida and Hiroyuki Goto and Satoshi Ida and Maiko Watanabe and Masaya Okuda and Tetsushiro Takeuchi and Takashi Murata and Tsuyoshi Tanaka},
  title = {Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study},
  journal = {Biomedical Sciences},
  volume = {4},
  number = {4},
  pages = {32-36},
  doi = {10.11648/j.bs.20180404.11},
  url = {https://doi.org/10.11648/j.bs.20180404.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.bs.20180404.11},
  abstract = {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.},
 year = {2019}
}

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TY  - JOUR
T1  - Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study
AU  - Sayaka Ida
AU  - Hiroyuki Goto
AU  - Satoshi Ida
AU  - Maiko Watanabe
AU  - Masaya Okuda
AU  - Tetsushiro Takeuchi
AU  - Takashi Murata
AU  - Tsuyoshi Tanaka
Y1  - 2019/01/14
PY  - 2019
N1  - https://doi.org/10.11648/j.bs.20180404.11
DO  - 10.11648/j.bs.20180404.11
T2  - Biomedical Sciences
JF  - Biomedical Sciences
JO  - Biomedical Sciences
SP  - 32
EP  - 36
PB  - Science Publishing Group
SN  - 2575-3932
UR  - https://doi.org/10.11648/j.bs.20180404.11
AB  - 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.
VL  - 4
IS  - 4
ER  -

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Author Information

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

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Plain Text BibTeX RIS

APA Style

Sayaka Ida, Hiroyuki Goto, Satoshi Ida, Maiko Watanabe, Masaya Okuda, et al. (2019). Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomedical Sciences, 4(4), 32-36. https://doi.org/10.11648/j.bs.20180404.11

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ACS Style

Sayaka Ida; Hiroyuki Goto; Satoshi Ida; Maiko Watanabe; Masaya Okuda, et al. Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomed. Sci. 2019, 4(4), 32-36. doi: 10.11648/j.bs.20180404.11

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AMA Style

Sayaka Ida, Hiroyuki Goto, Satoshi Ida, Maiko Watanabe, Masaya Okuda, et al. Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study. Biomed Sci. 2019;4(4):32-36. doi: 10.11648/j.bs.20180404.11

Copy | Download

@article{10.11648/j.bs.20180404.11,
  author = {Sayaka Ida and Hiroyuki Goto and Satoshi Ida and Maiko Watanabe and Masaya Okuda and Tetsushiro Takeuchi and Takashi Murata and Tsuyoshi Tanaka},
  title = {Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study},
  journal = {Biomedical Sciences},
  volume = {4},
  number = {4},
  pages = {32-36},
  doi = {10.11648/j.bs.20180404.11},
  url = {https://doi.org/10.11648/j.bs.20180404.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.bs.20180404.11},
  abstract = {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.},
 year = {2019}
}

Copy | Download

TY  - JOUR
T1  - Accuracy of a Factory Calibrated Retrospective CGM Device and the Comparison to a Conventionally Calibrated Retrospective CGM Device: A Pilot Study
AU  - Sayaka Ida
AU  - Hiroyuki Goto
AU  - Satoshi Ida
AU  - Maiko Watanabe
AU  - Masaya Okuda
AU  - Tetsushiro Takeuchi
AU  - Takashi Murata
AU  - Tsuyoshi Tanaka
Y1  - 2019/01/14
PY  - 2019
N1  - https://doi.org/10.11648/j.bs.20180404.11
DO  - 10.11648/j.bs.20180404.11
T2  - Biomedical Sciences
JF  - Biomedical Sciences
JO  - Biomedical Sciences
SP  - 32
EP  - 36
PB  - Science Publishing Group
SN  - 2575-3932
UR  - https://doi.org/10.11648/j.bs.20180404.11
AB  - 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.
VL  - 4
IS  - 4
ER  -

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