Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

Jian Zhou, Shuo Zhang, Liang Li, Yufei Wang, Wei Lu, Chunjun Sheng, Yiming Li, Yuqian Bao, Weiping Jia
Author Information
  1. Jian Zhou: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
  2. Shuo Zhang: Department of Endocrinology and Metabolism, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
  3. Liang Li: Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, Shanghai, China.
  4. Yufei Wang: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
  5. Wei Lu: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
  6. Chunjun Sheng: Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, Shanghai, China.
  7. Yiming Li: Department of Endocrinology and Metabolism, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
  8. Yuqian Bao: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. ORCID
  9. Weiping Jia: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. ORCID

Abstract

AIMS/INTRODUCTION: The present study aimed to investigate the performance of a new real-time continuous glucose monitoring system.
MATERIALS AND METHODS: Interstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values.
RESULTS: Among 1,678 paired sensor-reference values, 90.5% (95% confidence interval 89.1-91.9%) were within ±20%/20 mg/dL of the reference values, with a mean absolute relative difference of 9.1 ± 8.7% (95% CI: 8.9-9.2%). The percentages of paired sensor-reference values falling within zone A and B of the Clarke error grid analysis (EGA) and the type 1 diabetes consensus EGA were 99.1 and 99.8%. Continuous EGA showed that the percentages of accurate readings, benign errors, and erroneous readings were 89.9, 6.3 and 3.8%, respectively. Surveillance EGA showed that 90.6, 9.2, and 0.2% of sensor-reference values with no, slight and lower moderate risk, respectively. The mean absolute relative difference was 16.6, and 96.0% of the sensor values fell within zones A and B of the consensus EGA for hypoglycemia. More than 85% of sensor values were within ±20%/20 mg/dL of reference values, the mean absolute relative difference was <11, and >99.5% of the sensor values fell in zones A and B of the consensus EGA.
CONCLUSIONS: The Medtrum real-time continuous glucose monitoring system was numerically and clinically accurate over a large glucose range across 7 days of wear.

Keywords

References

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MeSH Term

Adult
Aged
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Female
Humans
Male
Middle Aged
Monitoring, Ambulatory
Pilot Projects
Prospective Studies
Reference Values
Reproducibility of Results
Young Adult

Word Cloud

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