scholarly journals A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes

2016 ◽  
Vol 11 (2) ◽  
pp. 290-295 ◽  
Author(s):  
Linong Ji ◽  
Xiaohui Guo ◽  
Lixin Guo ◽  
Qian Ren ◽  
Nan Yu ◽  
...  
Keyword(s):  
Glucose Monitoring ◽  
Relative Difference ◽  
Glucose Sensing ◽  
Chinese Patients ◽  
Chinese Adults ◽  
Flash Glucose Monitoring ◽  
Glucose Levels ◽  
Patients With Diabetes ◽  
Interstitial Glucose ◽  
Error Grid

Objective: Flash glucose monitoring is a new glucose sensing technique that measures interstitial glucose levels for up to 14 days and does not require any calibration. The aim of this study is to evaluate the performance of the new system in Chinese patients with diabetes. Methods: A multicenter, prospective, masked study was performed in a total of 45 subjects with diabetes. Subjects wore 2 sensors at the same time, for up to 14 days. The accuracy was evaluated against capillary blood glucose (BG) and venous Yellow Springs Instrument (YSI; Yellow Springs, OH) measurements. During all 14 days, subjects were asked to perform at least 8 capillary BG tests per day. Each subject attended 3 days of 8-hour clinic sessions to measure YSI and sensor readings every 15 minutes. Results: Forty subjects had evaluable glucose readings, with 6687 of 6696 (99.9%) sensor and capillary BG pairs within consensus error grid zones A and B, including 5824 (87.0%) in zone A. The 6969 sensor and venous YSI pairs resulted in 6965 (99.9%) pairs within zones A and B, including 5755 (82.6%) in zone A. The sensor pairs with BG and YSI result in mean absolute relative difference (MARD) of 10.0% and 10.7%, respectively. Overall between-sensor coefficient of variation (CV) was 8.0%, and the mean lag time was 3.1 (95% confidence interval 2.54 to 4.29) minutes. Conclusions: The system works well for people with diabetes in China, and it is easy to wear and use.

scholarly journals Accuracy of flash glucose monitoring and continuous glucose monitoring technologies: Implications for clinical practice

2018 ◽  
Vol 15 (3) ◽  
pp. 175-184 ◽  
Author(s):  
Ramzi A Ajjan ◽  
Michael H Cummings ◽  
Peter Jennings ◽  
Lalantha Leelarathna ◽  
Gerry Rayman ◽  
...  
Keyword(s):  
Continuous Glucose Monitoring ◽  
Diabetes Care ◽  
Interstitial Fluid ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Glucose Sensing ◽  
Sensor Data ◽  
Flash Glucose Monitoring ◽  
Fluid Sensor ◽  
Monitoring Technologies

Continuous glucose monitoring and flash glucose monitoring technologies measure glucose in the interstitial fluid and are increasingly used in diabetes care. Their accuracy, key to effective glycaemic management, is usually measured using the mean absolute relative difference of the interstitial fluid sensor compared to reference blood glucose readings. However, mean absolute relative difference is not standardised and has limitations. This review aims to provide a consensus opinion on assessing accuracy of interstitial fluid glucose sensing technologies. Mean absolute relative difference is influenced by glucose distribution and rate of change; hence, we express caution on the reliability of comparing mean absolute relative difference data from different study systems and conditions. We also review the pitfalls associated with mean absolute relative difference at different glucose levels and explore additional ways of assessing accuracy of interstitial fluid devices. Importantly, much data indicate that current practice of assessing accuracy of different systems based on individualised mean absolute relative difference results has limitations, which have potential clinical implications. Healthcare professionals must understand the factors that influence mean absolute relative difference as a metric for accuracy and look at additional assessments, such as consensus error grid analysis, when evaluating continuous glucose monitoring and flash glucose monitoring systems in diabetes care. This in turn will ensure that management decisions based on interstitial fluid sensor data are both effective and safe.

scholarly journals The Accuracy and Precision of the Continuously Stored Data from Flash Glucose Monitoring System in Type 2 Diabetes Patients during Standard Meal Tolerance Test

2020 ◽  
Vol 2020 ◽  
pp. 1-6 ◽  
Author(s):  
Rengna Yan ◽  
Huiqin Li ◽  
Xiaocen Kong ◽  
Xiaofang Zhai ◽  
Maoyuan Chen ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Glucose Monitoring ◽  
Flash Glucose Monitoring ◽  
Standard Meal ◽  
Grid Analysis ◽  
Sensor Glucose ◽  
Interstitial Glucose ◽  
Error Grid ◽  
Diabetes Patients

Background. The purpose of this study was to investigate the accuracy of the continuously stored data from the Abbott FreeStyle Libre flash glucose monitoring (FGM) system in Chinese diabetes patients during standard meal tests when glucose concentrations were rapidly changing. Subjects and Methods. Interstitial glucose levels were monitored for 14 days in 26 insulin-treated patients with type 2 diabetes using the FGM system. Standard meal tests were conducted to induce large glucose swings. Venous blood glucose (VBG) was tested at 0, 30, 60, and 120 min after standard meal tests in one middle day of the first and second weeks, respectively. The corresponding sensor glucose values were obtained from interpolating continuously stored data points. Assessment of accuracy was according to recent consensus recommendations with median absolute relative difference (MARD) and Clarke and Parkes error grid analysis (CEG and PEG). Results. Among 208 paired sensor-reference values, 100% were falling within zones A and B of the Clarke and Parkes error grid analysis. The overall MARD was 10.7% (SD, 7.8%). Weighted least squares regression analysis resulted in high agreement between the FGM sensor glucose and VBG readings. The overall MTT results showed that FGM was lower than actual VBG, with MAD of 22.1 mg/dL (1.2 mmol/L). At VBG rates of change of -1 to 0, 0 to 1, 1 to 2, and 2 to 3 mg/dl/min, MARD results were 11.4% (SD, 8.7%), 9.4% (SD, 6.5%), 9.9% (SD, 7.5%), and 9.5% (SD, 7.7%). At rapidly changing VBG concentrations (>3 mg/dl/min), MARD increased to 19.0%, which was significantly higher than slow changing BG groups. Conclusions. Continuously stored interstitial glucose measurements with the FGM system were found to be acceptable to evaluate VBG in terms of clinical decision during standard meal tests. The continuously stored data from the FGM system appeared to underestimate venous glucose and performed less well during rapid glucose changes.

scholarly journals Effect of Using Additional Readers for Flash Glucose Monitoring System on Metabolic Control, Safety, and the Incidence of Complications in Patients With Diabetes Mellitus

2020 ◽  
pp. 193229681990025 ◽  
Author(s):  
Oskar Kublin ◽  
Mariusz Stępień
Keyword(s):  
Quality Of Life ◽  
Metabolic Control ◽  
Online Survey ◽  
Glucose Monitoring ◽  
Flash Glucose Monitoring ◽  
Glucose Levels ◽  
Freestyle Libre ◽  
Patients With Diabetes ◽  
Do It Yourself

Background: The FreeStyle Libre is a flash glucose monitoring (FGM) system, and glucose levels are measured when the reader is brought to the sensor. Additional readers allow for the conversion into a continuous glucose monitoring (CGM) system. These transmitters read data from the sensor and send them to a bluetooth-enabled device thanks to which the user acquires glucose measurements automatically. This modification allows the patient to receive alerts when blood glucose values are abnormal. Methods: The study relied on the results of an anonymous online survey conducted among patients with diabetes or their caregivers who use Facebook groups. A total of 132 respondents who met certain criteria (diabetic who use FGM system longer than 3 months, at least 14 days per month) were enrolled in the study. Results: A significant decrease in self-reported glycated hemoglobin levels was found in adults and children using readers (variable: age P = .008; time P < .001), regardless of the age. The use of additional readers was associated with a significant decrease in the number of self-reported episodes of hypoglycemia ( P < .001) and an improvement in the quality of life (based on self-reported limitations in everyday activities, social contacts, work/school, or doing sports). Conclusion: The use of additional readers for FGM system improves the metabolic control of diabetes and the quality of life, and has a positive effect on the safety of treatment. Flash glucose monitoring used together with additional readers operates as a CGM system and seems to be helpful for patients for the monitoring of interstitial levels of glucose; however, they should be careful when they use do it yourself solution.

scholarly journals Accuracy of Flash Glucose Monitoring in Patients with Diabetes Mellitus on Hemodialysis and Its Relationship with Hydration Status

2020 ◽  
pp. 193229682097505
Author(s):  
Idoia Genua ◽  
Joan Sánchez-Hernandez ◽  
Maria José Martínez ◽  
Isabel Pujol ◽  
Jaume Places ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Patient Satisfaction ◽  
Ad Hoc ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Hydration Status ◽  
Flash Glucose Monitoring ◽  
Freestyle Libre ◽  
Interstitial Glucose ◽  
Capillary Glucose

Background: The use of flash-glucose monitoring system FreeStyle Libre (FSL) has demonstrated benefits in metabolic control and quality of life in different populations with diabetes mellitus (DM), being funded in many countries. Due to this, DM subjects on hemodialysis (HD) are using FSL despite the accuracy in this population being unclear. The aims of the present study are to assess the accuracy of FSL in DM subjects on HD, its relationship to hydration status, and patient satisfaction. Material and Methods: A prospective study in 16 patients with DM in a chronic HD program was conducted. Interstitial glucose values from FSL during a 14-day period were compared to capillary glucose measurements obtained at the same time. Hydration status was measured via bioimpedance spectroscopy. Satisfaction with FSL was obtained from an ad hoc satisfaction questionnaire. Results: A total of 766 paired interstitial and capillary glucose levels were analyzed. A correlation coefficient of 0.936 was determined and a mean absolute relative difference (MARD) value of 23%, increasing to 29% during HD. MARD was not related to hydration status. Interstitial glucose values were lower during HD (100.1 ± 17 mg/dL) than within the 12 hours after (125.1 ± 39 mg/dL; P = .012) and the days without HD (134.2 ± 32 mg/dL; P = .001). Subjects showed high satisfaction with FSL. Conclusion: The accuracy of FSL in DM patients on HD is lower than in other populations, especially during HD sessions and is not related with the hydration status. Despite this, the degree of patient satisfaction with FSL is very high.

Use of Continuous Glucose Monitoring in Patients with Diabetes Mellitus on Peritoneal Dialysis: Correlation with Glycated Hemoglobin and Detection of High Incidence of Unaware Hypoglycemia

2015 ◽  
Vol 41 (1-3) ◽  
pp. 18-24 ◽  
Author(s):  
Ahad Qayyum ◽  
Tahseen A. Chowdhury ◽  
Elizabeth Ley Oei ◽  
Stanley L. Fan
Keyword(s):  
Peritoneal Dialysis ◽  
Continuous Glucose Monitoring ◽  
Glycated Hemoglobin ◽  
Glucose Monitoring ◽  
Diabetic Control ◽  
Diabetic Patients ◽  
Glucose Levels ◽  
High Incidence ◽  
Patients With Diabetes ◽  
Interstitial Glucose

Introduction: Glycated hemoglobin is used to assess diabetic control although its accuracy in dialysis has been questioned. How does it compare to the Continuous Glucose Monitoring System (CGMS) in peritoneal dialysis (PD) patients? Methods: We conducted a retrospective analysis of 60 insulin-treated diabetic patients on PD. We determined the mean interstitial glucose concentration and the proportion of patients with hypoglycemia (<4 mmol/l) or hyperglycemia (>11 mmol/l). Results: The correlation between HbA1c and glucose was 0.48, p < 0.0001. Three of 15 patients with HbA1c >75 mmol/mol experienced significant hypoglycemia (14-144 min per day). The patients with frequent episodes of hypoglycemia could not be differentiated from those with frequent hyperglycemia by demographics or PD prescription. Conclusion: HbA1c and average glucose levels measured by the CGMS are only weakly correlated. On its own, HbA1c as an indicator of glycemic control in patients with diabetes on PD appears inadequate. We suggest that the CGMS technology should be more widely adopted.

scholarly journals Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Diabetes

2021 ◽  
Author(s):  
Georgia M. Davis ◽  
Elias K. Spanakis ◽  
Alexandra L. Migdal ◽  
Lakshmi G. Singh ◽  
Bonnie Albury ◽  
...  
Keyword(s):  
Critically Ill ◽  
Continuous Glucose Monitoring ◽  
Diabetes Management ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Hospitalized Patients ◽  
Matched Pair ◽  
Patients With Diabetes ◽  
Clarke Error Grid ◽  
Error Grid

<b>Background: </b>Advances in continuous glucose monitoring (CGM) have transformed ambulatory diabetes management. Until recently, inpatient use of CGM has remained investigational with limited data on its accuracy in the hospital setting. <p><b>Methods: </b>To analyze the accuracy of Dexcom G6 CGM,<b> </b>we compared retrospective matched-pair CGM and capillary point-of-care (POC) glucose data from three inpatient CGM studies (two interventional and one observational) in general medicine and surgery patients with diabetes treated with insulin. Analysis of accuracy metrics included mean absolute relative difference (MARD), median absolute relative difference (ARD), and proportion of CGM values within ±15, 20 and 30% or ±15, 20 and 30 mg/dL of POC reference values for blood glucose >100 mg/dL or ≤100 mg/dL, respectively (?/15, /20, 0/30). Clinical reliability was assessed using Clarke error grid analyses.</p> <p><b>Results: </b>A total of 218 patients were included (96% with type 2 diabetes) with a mean age of 60.6 ± 12 years. The overall MARD (n=4,067 matched glucose pairs) was 12.8% and median ARD was 10.1% [IQR 4.6, 17.6]. The proportion of readings meeting ?/15, /20 and 0/30 criteria were 68.7, 81.7, and 93.8%. Clarke error grid analysis showed 98.7% of all values in zones A+B. MARD and median ARD were higher in hypoglycemia (<70mg/dL) and severe anemia (hemoglobin <7g/dL).</p> <p><b>Conclusion: </b>Our results indicate that CGM technology is a reliable tool for hospital use and may help improve glucose monitoring in non-critically ill hospitalized patients with diabetes. </p>

scholarly journals Accuracy of Flash Glucose Monitoring During Postprandial Rest and Different Walking Conditions in Overweight or Obese Young Adults

2021 ◽  
Vol 12 ◽  
Author(s):  
Xiaoyuan Zhang ◽  
Fenghua Sun ◽  
Waris Wongpipit ◽  
Wendy Y. J. Huang ◽  
Stephen H. S. Wong
Keyword(s):  
Young Adults ◽  
Glucose Monitoring ◽  
Postprandial Glucose ◽  
Relative Difference ◽  
Flash Glucose Monitoring ◽  
Grid Analysis ◽  
Crossover Studies ◽  
Freestyle Libre ◽  
Clarke Error Grid ◽  
Error Grid

Aims: To investigate the accuracy of FreeStyle LibreTM flash glucose monitoring (FGM) relevant to plasma glucose (PG) measurements during postprandial rest and different walking conditions in overweight/obese young adults.Methods: Data of 40 overweight/obese participants from two randomized crossover studies were pooled into four trials: (1) sitting (SIT, n = 40); (2) walking continuously for 30 min initiated 20 min before individual postprandial glucose peak (PPGP) (20iP + CONT, n = 40); (3) walking continuously for 30 min initiated at PPGP (iP + CONT, n = 20); and (4) accumulated walking for 30 min initiated 20 min before PPGP (20iP + ACCU, n = 20). Paired FGM and PG were measured 4 h following breakfast.Results: The overall mean absolute relative difference (MARD) between PG and FGM readings was 16.4 ± 8.6% for SIT, 16.2 ± 4.7% for 20iP + CONT, 16.7 ± 12.2% for iP + CONT, and 19.1 ± 6.8% for 20iP + ACCU. The Bland–Altman analysis showed a bias of −1.03 mmol⋅L–1 in SIT, −0.89 mmol⋅L–1 in 20iP + CONT, −0.82 mmol⋅L–1 in iP + CONT, and −1.23 mmol⋅L–1 in 20iP + ACCU. The Clarke error grid analysis showed that 99.6–100% of the values in all trials fell within zones A and B.Conclusion: Although FGM readings underestimated PG, the FGM accuracy was overall clinically acceptable during postprandial rest and walking in overweight/obese young adults.

scholarly journals Self-measurement of Blood Glucose and Continuous Glucose Monitoring – Is There Only One Future?

2018 ◽  
Vol 14 (2) ◽  
pp. 24 ◽  
Author(s):  
Lutz Heinemann ◽  
Andreas Stuhr
Keyword(s):  
Blood Glucose ◽  
Continuous Glucose Monitoring ◽  
Subcutaneous Tissue ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Management Options ◽  
Measurement Quality ◽  
Glucose Levels ◽  
Wide Range ◽  
Patients With Diabetes

Monitoring glycaemic control in patients with diabetes has evolved dramatically over the past decades. The introduction of easy-to-use systems for self-monitoring of blood glucose (SMBG) utilising capillary blood samples has resulted in the availability of a wide range of systems, providing different measurement quality. Systems for continuous glucose monitoring (CGM) – used mainly in patients with type 1 diabetes (T1D) – were made possible by the development of glucose sensors that measure glucose levels in the interstitial fluid (ISF) in the subcutaneous tissue of the skin. CGM readings might not correspond exactly to SMBG measurement results taken at the same time, especially during rapid changes in either blood glucose or ISF glucose levels. The mean absolute relative difference is the most popular method used for characterising the measurement performance of CGM systems. Unlike the International Organization for Standardization 15197:2013 criteria for SMBG systems, no accuracy standards for CGM systems exist. Measurement quality of CGM systems can vary based on several factors, limiting their safety and effective use in managing diabetes. Patients have to be trained adequately to make safe and efficient use of CGM systems (like with SMBG systems). Also, systems for CGM must be evaluated in terms of patient safety and the ability to provide accurate measurements regardless of the fluctuation of glucose levels. As new technological advancements in glucose monitoring are essential for improved management options of diabetes, such as automated insulin dosing systems, there is a need for a critical view of all such developments. It is likely that both, SMBG and CGM systems, will play important future roles in the treatment of diabetes.

scholarly journals Evaluation of a New Noninvasive Glucose Monitoring Device by Means of Standardized Meal Experiments

2018 ◽  
Vol 12 (6) ◽  
pp. 1178-1183 ◽  
Author(s):  
Andreas Pfützner ◽  
Stephanie Strobl ◽  
Filiz Demircik ◽  
Lisa Redert ◽  
Johannes Pfützner ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Glucose Levels ◽  
Non Invasive ◽  
Invasive Component ◽  
Patients With Diabetes ◽  
Individual Calibration ◽  
Mathematical Algorithms ◽  
Invasive Device

Background: Frequent blood glucose readings are the most cumbersome aspect of diabetes treatment for many patients. The noninvasive TensorTip Combo Glucometer (CoG) component employs dedicated mathematical algorithms to analyze the collected signal and to predict tissue glucose at the fingertip. This study presents the performance of the CoG (the invasive and the noninvasive components) during a standardized meal experiment. Methods: Each of the 36 participants (18 females and males each, age: 49 ± 18 years, 14 healthy subjects, 6 type 1 and 16 type 2 patients) received a device for conducting calibration at home. Thereafter, they ingested a standardized meal. Blood glucose was assessed from capillary blood samples by means of the (non)invasive device, YSI Stat 2300 plus, Contour Next at time points –30, 0, 15, 30, 45, 60, 75, 90, 120, 150, and 180 minutes. Statistical analysis was performed by consensus error grid (CEG) and calculation of mean absolute relative difference (MARD) in comparison to YSI. Results: For the noninvasive (NI) CoG technology, 100% of the data pairs were found in CEG zones A (96.6%) and B (3.4%); 100% were seen in zone A for the invasive component and Contour Next. MARD was calculated to be 4.2% for Contour Next, 9.2% for the invasive component, and 14.4% for the NI component. Conclusions: After appropriate individual calibration of the NI technology, both the NI and the invasive CoG components reliably tracked tissue and blood glucose values, respectively. This may enable patients with diabetes to monitor their glucose levels frequently, reliably, and most of all pain-free.

Sign in / Sign up

Export Citation Format

Share Document