Effects of Simulated Altitude on Blood Glucose Meter Performance: Implications for In-Flight Blood Glucose Monitoring

Background: Currently, two different types of continuous glucose monitoring (CGM) systems are available: real time (rt) CGM systems that continuously provide glucose values and intermittent-scanning (is) CGM systems. This study compared accuracy of an rtCGM and an isCGM system when worn in parallel. Methods: Dexcom G5 Mobile (DG5) and FreeStyle Libre (FL) were worn in parallel by 27 subjects for 14 days including two clinic sessions with induced glucose excursions. The percentage of CGM values within ±20% or ±20 mg/dL of the laboratory comparison method results (YSI 2300 STAT Plus, YSI Inc., Yellow Springs, OH, United States; glucose oxidase based) or blood glucose meter values and mean absolute relative difference (MARD) were calculated. Consensus error grid and continuous glucose error grid analyses were performed to assess clinical accuracy. Results: Both systems displayed clinically accurate readings. Compared to laboratory comparison method results during clinic sessions, DG5 had 91.5% of values within ±20%/20 mg/dL and a MARD of 9.5%; FL had 82.5% of scanned values within ±20%/20 mg/dL and an MARD of 13.6%. Both systems showed a lower level of performance during the home phase and when using the blood glucose meter as reference. Conclusion: The two systems tested in this study represent two different principles of CGM. DG5 generally provided higher accordance with laboratory comparison method results than FL.

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Comparison of a Continuous Glucose Monitoring System with a Portable Blood Glucose Meter to Determine Insulin Dose in Cats with Diabetes Mellitus

Journal of Veterinary Internal Medicine ◽

10.1111/j.1939-1676.2011.00778.x ◽

2011 ◽

Vol 25 (5) ◽

pp. 1084-1088 ◽

Cited By ~ 15

Author(s):

S. Dietiker-Moretti ◽

C. Müller ◽

N. Sieber-Ruckstuhl ◽

F. Tschuor ◽

M. Osto ◽

...

Keyword(s):

Diabetes Mellitus ◽

Blood Glucose ◽

Monitoring System ◽

Continuous Glucose Monitoring ◽

Insulin Dose ◽

Glucose Monitoring ◽

Continuous Glucose Monitoring System ◽

Glucose Meter ◽

Blood Glucose Meter

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Evaluation of the Accuracy and Safety of a Portable Metabolic Heat Conformation-Based Non-invasive Glucose Meter: A Multicentre Clinical Study. (Preprint)

10.2196/preprints.32333 ◽

2021 ◽

Author(s):

Yuanmeng Xu ◽

Ang Li ◽

Chenyang Wu ◽

Zhanxiao Geng ◽

Junqing Zhang ◽

...

Keyword(s):

Insulin Resistance ◽

Blood Glucose ◽

Clinical Study ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Glucose Measurement ◽

Non Invasive ◽

Metabolic Heat ◽

Fasted State ◽

Glucose Meter

BACKGROUND Non-invasive blood glucose measurement is expected to be an ideal way for glucose monitoring, although most of the methods are under study and yet to be verified in large-scale clinical trials. OBJECTIVE We intend to evaluate the stability, accuracy of the metabolic heat conformation (MHC)-based non-invasive glucometer in a multicentre, self-controlled clinical trial. This device obtained the first medical device registration certificate awarded by the National Medical Products Administration of China (NMPA). METHODS The clinical study was conducted at three sites on 200 subjects who received glucose measurement with a non-invasive glucometer, the Contour Plus blood glucose monitoring system, and venous plasma glucose (VPG) measurements, in a fasted state and at 2 and 4 hours after meals. Trial Registration: ChiCTR1900020523. RESULTS The non-invasive and VPG measurements showed 93.9% (95% CI, 91.7–95.6%) of the values in zone A + B in a Consensus Error Grid. The measurements obtained in a fasted state and at 2 hours after meals are more accurate, with 99.0% and 97.0% of the values in zone A + B, respectively. The proportion of values in zone A + B and the correlation coefficients in subjects who did not receive insulin were 3.1% and 0.0596 higher than in those who received insulin. The accuracy of the non-invasive glucometer was influenced by the level of islet cell function and insulin resistance, which had a correlation coefficient with the MARD of -0.0961 (p=0.020) and -0.1577 (p=0.00012), respectively. CONCLUSIONS The MHC-based non-invasive glucometer demonstrates generally high stability and accuracy in the glucose monitoring of diabetic patients. The calculation model needs to be further explored and optimised for patients with different diabetes subtypes, levels of insulin resistance and insulin secretion capacity. CLINICALTRIAL the name of the trial registry : A multi-center study for evaluating the accuracy and safety of noninvasive glucose meter in people with diabetes or impaired glucose regulation (impaired fasting glucose and impaired glucose tolerance), using an experimental test system as a reference. registration number : ChiCTR1900020523 URL : https://www.chictr.org.cn/showproj.aspx?proj=33857

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Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models

Journal of Diabetes Science and Technology ◽

10.1177/1932296819889639 ◽

2019 ◽

Vol 14 (3) ◽

pp. 513-518

Author(s):

Andrew W. Lyon ◽

Martha E. Lyon

Keyword(s):

Experimental Data ◽

Blood Glucose ◽

Glucose Monitoring ◽

Reference Method ◽

Simulation Models ◽

Blood Glucose Monitoring ◽

Self Monitoring ◽

Fda Guidance ◽

Performance Expectation ◽

Glucose Meter

Background: The objective of this study was to estimate the combinations of total bias and total imprecision required for devices to meet the Food and Drug Administration (FDA) specifications using Monte Carlo simulation rather than collection and analysis of experimental data. Methods: A model Gaussian distribution of true-glucose values was altered by adding bias and imprecision to create measured-glucose values affected by analytic error. The fraction of measured-glucose values that met the 2018 FDA criteria for blood glucose monitoring system (BGMS) or self-monitoring blood glucose (SMBG) devices was determined as a function of bias and imprecision. Results: The BGMS model determined that a maximum total imprecision of 6% was required with no bias, and with a total bias of +10 mg/dL the total imprecision allowed was reduced to 5% to achieve the 95% FDA performance expectation: 95% of results ≥75 mg/dL within ±12% and 95% of results <75 mg/dL within ±12 mg/dL. The SMBG model determined that a maximum total imprecision of 6% was required at no bias, and with a total bias of +10 mg/dL the total imprecision allowed was reduced to 4% to achieve the 98% FDA expectation: 98% of results ±75 mg/dL within ±15% and 98% of results <75 mg/dL within ±15 mg/dL. Conclusions: The 2018 FDA guidance criteria require strict conditions for glucose meter clinical trials to achieve <10 mg/dL total bias and total imprecision of <5%. Total imprecision and bias values assessed in models in this study represent the cumulative imprecision and bias errors for the glucose meters, the reference method, and preanalytic processes.

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