Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study

Takashi Murata; Shinsuke Nirengi; Yaeko Kawaguchi; Shin Sukino; Tomokazu Watanabe; Naoki Sakane

doi:doi:10.11648/j.bs.20170306.11

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Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study

Takashi Murata, Shinsuke Nirengi, Yaeko Kawaguchi, Shin Sukino, Tomokazu Watanabe, Naoki Sakane

Published in Biomedical Sciences (Volume 3, Issue 6)

Received: 12 September 2017 Accepted: 30 September 2017 Published: 23 October 2017

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Abstract

Free Style Libre Pro, a novel continuous glucose monitoring (CGM) device for retrospective assessment of glycemic excursion, does not require calibration during the measurement period. In this study, the accuracy of FreeStyle Libre Pro in normal glucose levels was investigated. Two meal tests, on the 7th day and 9th day of CGM usage, were performed in five non-diabetic adults. Venous blood samples were obtained at baseline, and at 2 hours, 4 hours and 6 hours after the meal. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were compared. Subjects were aged 41.4±7.6 years, 40% male, with body mass index 21.7±2.6, HbA1c 5.6±0.3% and a fasting plasma glucose level of 95.4±2.1 mg/dl. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were significantly different; 94.4±1.8 vs. 111.2±8.5 mg/dl (P <0.01) at baseline, 95.6±7.0 vs. 122.6±8.8 mg/dl (P <0.01) at 2 hours, 90.1±4.3 vs. 111.2±13.0 mg/dl (P <0.01) at 4 hours, and 88.7±3.2 vs. 105.5±7.1 mg/dl (P <0.01) at 6 hours. The absolute difference between the two methods was 17.7±7.5 (minimum 5 - maximum 27) mg/dl at baseline, 27.0±9.4 (minimum 8 - maximum 40) mg/dl at 2 hours, 21.1±11.3 (minimum 7 - maximum 42) mg/dl at 4 hours, 16.8±5.4 (minimum 7 - maximum 23) mg/dl at 6 hours, and 20.7±9.3 (minimum 5 - maximum 42) mg/dl for all time points, respectively. The absolute relative difference between them was 18.7±7.8 (minimum 5.3 - maximum 28.7)% at baseline, 28.7±10.7 (minimum 7.7 - maximum 45.5)% at 2 hours, 23.3±12.2 (minimum 7.9 - maximum 45.2)% at 4 hours, 18.9±6.0 (minimum 8.0 - maximum 26.2)% at 6 hours, and 22.4±10.0 (minimum 5.3 - maximum 43.5)% for all time points, respectively. The ratio of values measured by FreeStyle Libre Pro within the interval of ±15 mg/dl in less than 100 mg/dl or within the interval of ±15% in not less than 100 mg/dl plasma glucose levels was 30.0% at baseline, 10.0% at 2 hours, 40.0% at 4 hours, 50.0% at 6 hours and 32.5% for all time points, respectively. These study results suggest FreeStyle Libre Pro may not be sufficiently accurate in normal glucose levels.

Published in	Biomedical Sciences (Volume 3, Issue 6)
DOI	10.11648/j.bs.20170306.11
Page(s)	109-113
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, Plasma Glucose, Free Style Libre Pro, Accuracy, Normal Glucose Levels

References

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APA Style

Takashi Murata, Shinsuke Nirengi, Yaeko Kawaguchi, Shin Sukino, Tomokazu Watanabe, et al. (2017). Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomedical Sciences, 3(6), 109-113. https://doi.org/10.11648/j.bs.20170306.11

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ACS Style

Takashi Murata; Shinsuke Nirengi; Yaeko Kawaguchi; Shin Sukino; Tomokazu Watanabe, et al. Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomed. Sci. 2017, 3(6), 109-113. doi: 10.11648/j.bs.20170306.11

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AMA Style

Takashi Murata, Shinsuke Nirengi, Yaeko Kawaguchi, Shin Sukino, Tomokazu Watanabe, et al. Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomed Sci. 2017;3(6):109-113. doi: 10.11648/j.bs.20170306.11

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@article{10.11648/j.bs.20170306.11,
  author = {Takashi Murata and Shinsuke Nirengi and Yaeko Kawaguchi and Shin Sukino and Tomokazu Watanabe and Naoki Sakane},
  title = {Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study},
  journal = {Biomedical Sciences},
  volume = {3},
  number = {6},
  pages = {109-113},
  doi = {10.11648/j.bs.20170306.11},
  url = {https://doi.org/10.11648/j.bs.20170306.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.bs.20170306.11},
  abstract = {Free Style Libre Pro, a novel continuous glucose monitoring (CGM) device for retrospective assessment of glycemic excursion, does not require calibration during the measurement period. In this study, the accuracy of FreeStyle Libre Pro in normal glucose levels was investigated. Two meal tests, on the 7th day and 9th day of CGM usage, were performed in five non-diabetic adults. Venous blood samples were obtained at baseline, and at 2 hours, 4 hours and 6 hours after the meal. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were compared. Subjects were aged 41.4±7.6 years, 40% male, with body mass index 21.7±2.6, HbA1c 5.6±0.3% and a fasting plasma glucose level of 95.4±2.1 mg/dl. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were significantly different; 94.4±1.8 vs. 111.2±8.5 mg/dl (P P P P <0.01) at 6 hours. The absolute difference between the two methods was 17.7±7.5 (minimum 5 - maximum 27) mg/dl at baseline, 27.0±9.4 (minimum 8 - maximum 40) mg/dl at 2 hours, 21.1±11.3 (minimum 7 - maximum 42) mg/dl at 4 hours, 16.8±5.4 (minimum 7 - maximum 23) mg/dl at 6 hours, and 20.7±9.3 (minimum 5 - maximum 42) mg/dl for all time points, respectively. The absolute relative difference between them was 18.7±7.8 (minimum 5.3 - maximum 28.7)% at baseline, 28.7±10.7 (minimum 7.7 - maximum 45.5)% at 2 hours, 23.3±12.2 (minimum 7.9 - maximum 45.2)% at 4 hours, 18.9±6.0 (minimum 8.0 - maximum 26.2)% at 6 hours, and 22.4±10.0 (minimum 5.3 - maximum 43.5)% for all time points, respectively. The ratio of values measured by FreeStyle Libre Pro within the interval of ±15 mg/dl in less than 100 mg/dl or within the interval of ±15% in not less than 100 mg/dl plasma glucose levels was 30.0% at baseline, 10.0% at 2 hours, 40.0% at 4 hours, 50.0% at 6 hours and 32.5% for all time points, respectively. These study results suggest FreeStyle Libre Pro may not be sufficiently accurate in normal glucose levels.},
 year = {2017}
}

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TY  - JOUR
T1  - Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study
AU  - Takashi Murata
AU  - Shinsuke Nirengi
AU  - Yaeko Kawaguchi
AU  - Shin Sukino
AU  - Tomokazu Watanabe
AU  - Naoki Sakane
Y1  - 2017/10/23
PY  - 2017
N1  - https://doi.org/10.11648/j.bs.20170306.11
DO  - 10.11648/j.bs.20170306.11
T2  - Biomedical Sciences
JF  - Biomedical Sciences
JO  - Biomedical Sciences
SP  - 109
EP  - 113
PB  - Science Publishing Group
SN  - 2575-3932
UR  - https://doi.org/10.11648/j.bs.20170306.11
AB  - Free Style Libre Pro, a novel continuous glucose monitoring (CGM) device for retrospective assessment of glycemic excursion, does not require calibration during the measurement period. In this study, the accuracy of FreeStyle Libre Pro in normal glucose levels was investigated. Two meal tests, on the 7th day and 9th day of CGM usage, were performed in five non-diabetic adults. Venous blood samples were obtained at baseline, and at 2 hours, 4 hours and 6 hours after the meal. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were compared. Subjects were aged 41.4±7.6 years, 40% male, with body mass index 21.7±2.6, HbA1c 5.6±0.3% and a fasting plasma glucose level of 95.4±2.1 mg/dl. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were significantly different; 94.4±1.8 vs. 111.2±8.5 mg/dl (P P P P <0.01) at 6 hours. The absolute difference between the two methods was 17.7±7.5 (minimum 5 - maximum 27) mg/dl at baseline, 27.0±9.4 (minimum 8 - maximum 40) mg/dl at 2 hours, 21.1±11.3 (minimum 7 - maximum 42) mg/dl at 4 hours, 16.8±5.4 (minimum 7 - maximum 23) mg/dl at 6 hours, and 20.7±9.3 (minimum 5 - maximum 42) mg/dl for all time points, respectively. The absolute relative difference between them was 18.7±7.8 (minimum 5.3 - maximum 28.7)% at baseline, 28.7±10.7 (minimum 7.7 - maximum 45.5)% at 2 hours, 23.3±12.2 (minimum 7.9 - maximum 45.2)% at 4 hours, 18.9±6.0 (minimum 8.0 - maximum 26.2)% at 6 hours, and 22.4±10.0 (minimum 5.3 - maximum 43.5)% for all time points, respectively. The ratio of values measured by FreeStyle Libre Pro within the interval of ±15 mg/dl in less than 100 mg/dl or within the interval of ±15% in not less than 100 mg/dl plasma glucose levels was 30.0% at baseline, 10.0% at 2 hours, 40.0% at 4 hours, 50.0% at 6 hours and 32.5% for all time points, respectively. These study results suggest FreeStyle Libre Pro may not be sufficiently accurate in normal glucose levels.
VL  - 3
IS  - 6
ER  -

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Author Information

Takashi Murata

Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Shinsuke Nirengi

Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Yaeko Kawaguchi

Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Shin Sukino

Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Tomokazu Watanabe

Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
Naoki Sakane

Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan

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APA Style

Takashi Murata, Shinsuke Nirengi, Yaeko Kawaguchi, Shin Sukino, Tomokazu Watanabe, et al. (2017). Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomedical Sciences, 3(6), 109-113. https://doi.org/10.11648/j.bs.20170306.11

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ACS Style

Takashi Murata; Shinsuke Nirengi; Yaeko Kawaguchi; Shin Sukino; Tomokazu Watanabe, et al. Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomed. Sci. 2017, 3(6), 109-113. doi: 10.11648/j.bs.20170306.11

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AMA Style

Takashi Murata, Shinsuke Nirengi, Yaeko Kawaguchi, Shin Sukino, Tomokazu Watanabe, et al. Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study. Biomed Sci. 2017;3(6):109-113. doi: 10.11648/j.bs.20170306.11

Copy | Download

@article{10.11648/j.bs.20170306.11,
  author = {Takashi Murata and Shinsuke Nirengi and Yaeko Kawaguchi and Shin Sukino and Tomokazu Watanabe and Naoki Sakane},
  title = {Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study},
  journal = {Biomedical Sciences},
  volume = {3},
  number = {6},
  pages = {109-113},
  doi = {10.11648/j.bs.20170306.11},
  url = {https://doi.org/10.11648/j.bs.20170306.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.bs.20170306.11},
  abstract = {Free Style Libre Pro, a novel continuous glucose monitoring (CGM) device for retrospective assessment of glycemic excursion, does not require calibration during the measurement period. In this study, the accuracy of FreeStyle Libre Pro in normal glucose levels was investigated. Two meal tests, on the 7th day and 9th day of CGM usage, were performed in five non-diabetic adults. Venous blood samples were obtained at baseline, and at 2 hours, 4 hours and 6 hours after the meal. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were compared. Subjects were aged 41.4±7.6 years, 40% male, with body mass index 21.7±2.6, HbA1c 5.6±0.3% and a fasting plasma glucose level of 95.4±2.1 mg/dl. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were significantly different; 94.4±1.8 vs. 111.2±8.5 mg/dl (P P P P <0.01) at 6 hours. The absolute difference between the two methods was 17.7±7.5 (minimum 5 - maximum 27) mg/dl at baseline, 27.0±9.4 (minimum 8 - maximum 40) mg/dl at 2 hours, 21.1±11.3 (minimum 7 - maximum 42) mg/dl at 4 hours, 16.8±5.4 (minimum 7 - maximum 23) mg/dl at 6 hours, and 20.7±9.3 (minimum 5 - maximum 42) mg/dl for all time points, respectively. The absolute relative difference between them was 18.7±7.8 (minimum 5.3 - maximum 28.7)% at baseline, 28.7±10.7 (minimum 7.7 - maximum 45.5)% at 2 hours, 23.3±12.2 (minimum 7.9 - maximum 45.2)% at 4 hours, 18.9±6.0 (minimum 8.0 - maximum 26.2)% at 6 hours, and 22.4±10.0 (minimum 5.3 - maximum 43.5)% for all time points, respectively. The ratio of values measured by FreeStyle Libre Pro within the interval of ±15 mg/dl in less than 100 mg/dl or within the interval of ±15% in not less than 100 mg/dl plasma glucose levels was 30.0% at baseline, 10.0% at 2 hours, 40.0% at 4 hours, 50.0% at 6 hours and 32.5% for all time points, respectively. These study results suggest FreeStyle Libre Pro may not be sufficiently accurate in normal glucose levels.},
 year = {2017}
}

Copy | Download

TY  - JOUR
T1  - Accuracy of a Novel “Factory-Calibrated” Continuous Glucose Monitoring Device in Normal Glucose Levels: A Pilot Study
AU  - Takashi Murata
AU  - Shinsuke Nirengi
AU  - Yaeko Kawaguchi
AU  - Shin Sukino
AU  - Tomokazu Watanabe
AU  - Naoki Sakane
Y1  - 2017/10/23
PY  - 2017
N1  - https://doi.org/10.11648/j.bs.20170306.11
DO  - 10.11648/j.bs.20170306.11
T2  - Biomedical Sciences
JF  - Biomedical Sciences
JO  - Biomedical Sciences
SP  - 109
EP  - 113
PB  - Science Publishing Group
SN  - 2575-3932
UR  - https://doi.org/10.11648/j.bs.20170306.11
AB  - Free Style Libre Pro, a novel continuous glucose monitoring (CGM) device for retrospective assessment of glycemic excursion, does not require calibration during the measurement period. In this study, the accuracy of FreeStyle Libre Pro in normal glucose levels was investigated. Two meal tests, on the 7th day and 9th day of CGM usage, were performed in five non-diabetic adults. Venous blood samples were obtained at baseline, and at 2 hours, 4 hours and 6 hours after the meal. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were compared. Subjects were aged 41.4±7.6 years, 40% male, with body mass index 21.7±2.6, HbA1c 5.6±0.3% and a fasting plasma glucose level of 95.4±2.1 mg/dl. The plasma glucose levels and the glucose levels measured by FreeStyle Libre Pro were significantly different; 94.4±1.8 vs. 111.2±8.5 mg/dl (P P P P <0.01) at 6 hours. The absolute difference between the two methods was 17.7±7.5 (minimum 5 - maximum 27) mg/dl at baseline, 27.0±9.4 (minimum 8 - maximum 40) mg/dl at 2 hours, 21.1±11.3 (minimum 7 - maximum 42) mg/dl at 4 hours, 16.8±5.4 (minimum 7 - maximum 23) mg/dl at 6 hours, and 20.7±9.3 (minimum 5 - maximum 42) mg/dl for all time points, respectively. The absolute relative difference between them was 18.7±7.8 (minimum 5.3 - maximum 28.7)% at baseline, 28.7±10.7 (minimum 7.7 - maximum 45.5)% at 2 hours, 23.3±12.2 (minimum 7.9 - maximum 45.2)% at 4 hours, 18.9±6.0 (minimum 8.0 - maximum 26.2)% at 6 hours, and 22.4±10.0 (minimum 5.3 - maximum 43.5)% for all time points, respectively. The ratio of values measured by FreeStyle Libre Pro within the interval of ±15 mg/dl in less than 100 mg/dl or within the interval of ±15% in not less than 100 mg/dl plasma glucose levels was 30.0% at baseline, 10.0% at 2 hours, 40.0% at 4 hours, 50.0% at 6 hours and 32.5% for all time points, respectively. These study results suggest FreeStyle Libre Pro may not be sufficiently accurate in normal glucose levels.
VL  - 3
IS  - 6
ER  -

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