scholarly journals Simple Post-Processing of Continuous Glucose Monitoring Measurements Improves Endpoints in Clinical Trials

2019 ◽  
Vol 14 (6) ◽  
pp. 1074-1078 ◽  
Author(s):  
Morten Hasselstrøm Jensen ◽  
Claus Dethlefsen ◽  
Ole Hejlesen ◽  
Peter Vestergaard
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Continuous Glucose Monitoring ◽  
State Of The Art ◽  
Glucose Monitoring ◽  
Postprandial Glucose ◽  
Relative Difference ◽  
Time Shift ◽  
Post Processing ◽  
Processing Procedure

Background: Continuous glucose monitoring (CGM) is a powerful tool to be considered both in clinical practice and clinical trials. However, CGM has been criticized for being inaccurate for many reasons including a physiological delay. This study sought to investigate the current delay issue and propose a simple post-processing procedure. Method: More than a million hours of the Dexcom G4 CGM from 472 subjects investigated in a state-of-the-art clinical trial were analyzed by time shifting the CGM measurements and comparing them to plasma glucose (PG) measurements. The resultant CGM measurements were then assessed in relation to real-world clinical research endpoints. Results: A CGM time shift of −9 minutes was optimal and reduced mean absolute relative difference (MARD) statistically significantly with 1.0% point. The MARD reduction resulted in better clinical research endpoints of hypoglycemia and postprandial glucose increments. Conclusions: The delay in CGM is still an issue. The delay in this study was identified to be 9 minutes compared to PG. With a simple post-processing approach of time shifting the CGM measurements with −9 minutes, it was possible to obtain a statistically significantly lower MARD and subsequently obtain clinical research endpoints of improved validity.

scholarly journals Analysis of “Simple Post-Processing of Continuous Glucose Monitoring Measurements Improves Endpoints in Clinical Trials”

2019 ◽  
Vol 14 (6) ◽  
pp. 1079-1080
Author(s):  
Günther Schmelzeisen-Redeker
Keyword(s):  
Clinical Trials ◽  
Continuous Glucose Monitoring ◽  
Time Delays ◽  
Glucose Monitoring ◽  
Postprandial Glucose ◽  
Efficacy And Safety ◽  
Post Processing ◽  
Safety Study ◽  
Predictive Algorithms ◽  
Analytical Accuracy

Jensen et al used continuous glucose monitoring (CGM) data of the Dexcom G4 Platinum (DG4P) sensor obtained in a clinical efficacy and safety study of Novo Nordisk’s new insulin Fiasp® to calculate the CGM time delay versus plasma glucose (PG) and self-measured blood glucose (SMBG) measurements (9-10 min). Shifting the CGM signal by 9 min backward in time versus PG and SMBG data improved the analytical accuracy of the DG4P sensor and the reliability of clinical research endpoint (hypoglycemia, postprandial glucose increments) detection. Since this method takes advantage of post-processing of CGM data, it is particularly suited for the optimization of data processing in clinical studies. In contrast, real-time corrections of time delays need predictive algorithms.

scholarly journals Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space

2019 ◽  
Vol 14 (1) ◽  
pp. 135-150 ◽  
Author(s):  
Lutz Heinemann ◽  
Michael Schoemaker ◽  
Günther Schmelzeisen-Redecker ◽  
Rolf Hinzmann ◽  
Adham Kassab ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Continuous Glucose Monitoring ◽  
Medical Devices ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
High Quality ◽  
Quality Performance ◽  
Performance Of Systems ◽  
Patients With Diabetes ◽  
The Mean

High-quality performance of medical devices for glucose monitoring is important for a safe and efficient usage of this diagnostic option by patients with diabetes. The mean absolute relative difference (MARD) parameter is used most often to characterize the measurement performance of systems for continuous glucose monitoring (CGM). Calculation of this parameter is relatively easy and comparison of the MARD numbers between different CGM systems appears to be straightforward on the first glance. However, a closer look reveals that a number of complex aspects make interpretation of the MARD numbers provided by the manufacturer for their CGM systems difficult. In this review, these aspects are discussed and considerations are made for a systematic and appropriate evaluation of the MARD in clinical trials. The MARD should not be used as the sole parameter to characterize CGM systems, especially when it comes to nonadjunctive usage of such systems.

The Accuracy of Continuous Glucose Monitoring in the Medical Intensive Care Unit

2021 ◽  
pp. 193229682110275
Author(s):  
Wannita Tingsarat ◽  
Patinut Buranasupkajorn ◽  
Weerapan Khovidhunkit ◽  
Patchaya Boonchaya-anant ◽  
Nitchakarn Laichuthai
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Continuous Glucose Monitoring ◽  
Medical Intensive Care Unit ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Risk Zone ◽  
Medical Intensive Care ◽  
Vasopressor Use ◽  
Error Grid

Objective: To assess the accuracy of continuous glucose monitoring (CGM) in medical intensive care unit (MICU) patients. Methods: A Medtronic Enlite® sensor accuracy was assessed versus capillary blood glucose (CBG) and plasma glucose (PG) using the mean absolute relative difference (MARD), surveillance error grid (SEG) analysis and modified Bland-Altman plots. Results: Using CBG as a reference, MARD was 6.6%. Overall, 99.7% of the CGM readings were within the “no risk” zone. No significant differences in accuracy were seen within vasopressor subgroups. Using PG as the reference, MARD was 8.8%. The surveillance error grid analysis showed 95.2% of glucose readings were within the “no risk” zone. There were no device-related adverse events. Conclusion: The CGM sensor showed acceptable accuracy in MICU patients, regardless of vasopressor use.

scholarly journals Continuous Glucose Monitoring Accuracy Results Vary between Assessment at Home and Assessment at the Clinical Research Center

2012 ◽  
Vol 6 (5) ◽  
pp. 1103-1106 ◽  
Author(s):  
Yoeri M. Luijf ◽  
Angelo Avogaro ◽  
Carsten Benesch ◽  
Daniela Bruttomesso ◽  
Claudio Cobelli ◽  
...  
Keyword(s):  
Clinical Research ◽  
Continuous Glucose Monitoring ◽  
Glucose Monitoring ◽  
Research Center ◽  
Clinical Research Center ◽  
Monitoring Accuracy ◽  
At Home

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.

Utility of Continuous Glucose Monitoring vs. Meal Study in Detecting Hypoglycemia After Gastric Bypass

2021 ◽  
Author(s):  
Henri Honka ◽  
Janet Chuang ◽  
David D’Alessio ◽  
Marzieh Salehi
Keyword(s):  
Gastric Bypass ◽  
Continuous Glucose Monitoring ◽  
Gastric Bypass Surgery ◽  
Late Complication ◽  
Glucose Monitoring ◽  
Glucose Variability ◽  
Postprandial Glucose ◽  
Healthy Weight ◽  
Free Living ◽  
Carbohydrate Ingestion

Abstract Context Gastric bypass (GB) increases postprandial glucose excursion, which in turn can predispose to the late complication of hypoglycemia. Diagnosis remains challenging and requires documentation of symptoms associated with low glucose, and relief of symptom when glucose is normalized (Whipple’s triad). Objective To compare the yield of mixed meal test (MMT) and continuous glucose monitoring system (CGMS) in detecting hypoglycemia after gastric bypass surgery (GB). Setting The study was conducted at General Clinical Research Unit, Cincinnati Children’s Hospital (Cincinnati, OH, United States). Methods Glucose profiles were evaluated in 15 patients with documented recurrent clinical hypoglycemia after GB, 8 matched asymptomatic GB subjects, and 9 healthy weight-matched non-operated controls using MMT in a control setting and CGMS under free-living conditions. Results Patients with prior GB had larger glucose variability during both MMT and CGMS when compared to non-surgical controls regardless of their hypoglycemic status. Sensitivity (71 vs. 47 %) and specificity (100 vs. 88 %) of MMT in detecting hypoglycemia was superior to CGMS. Conclusions Our findings indicate that a fixed carbohydrate ingestion during MMT is a more reliable test to diagnose GB-related hypoglycemia compared to CGMS during free-living state.

scholarly journals A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States

2019 ◽  
Vol 15 (1) ◽  
pp. 160-166 ◽  
Author(s):  
Kevin Cowart
Keyword(s):  
Diabetes Mellitus ◽  
Continuous Glucose Monitoring ◽  
Glucose Monitoring ◽  
The United States ◽  
Relative Difference ◽  
Cochrane Library ◽  
Additional Clinical Trial ◽  
Novel Approach

Background: Although real-time continuous glucose monitoring (rtCGM) has been shown to improve glycemic control in patients with type 1 diabetes mellitus and type 2 diabetes mellitus treated with insulin, rates of adoption have been low. A novel approach, with the use of a long-term implantable continuous glucose monitoring (LTI CGM) has the potential to overcome barriers to rtCGM. The purpose of this review is to provide a background on the first LTI CGM technology to be approved, along with a review of contraindications, interference, safety, accuracy, and efficacy. Considerations for patient selection are discussed based on the available evidence. Methods: PubMed, EMBASE, and Cochrane Library were searched for keywords and subject headings to identify studies assessing LTI CGM. Results: Seven studies were identified which assessed LTI CGM. Mean absolute relative difference is similar to available CGM devices. Rates of adverse events were low. Change in hemoglobin A1c with LTI CGM may be comparable to rtCGM. Conclusions: Based on the available evidence, LTI CGM appears to be safe and accurate. Additional clinical trial investigation is warranted to evaluate the glycemic efficacy of LTI CGM.

Effects of high-intensity interval exercise versus continuous moderate-intensity exercise on postprandial glycemic control assessed by continuous glucose monitoring in obese adults

2014 ◽  
Vol 39 (7) ◽  
pp. 835-841 ◽  
Author(s):  
Jonathan P. Little ◽  
Mary E. Jung ◽  
Amy E. Wright ◽  
Wendi Wright ◽  
Ralph J.F. Manders
Keyword(s):  
Continuous Glucose Monitoring ◽  
High Intensity ◽  
Glucose Monitoring ◽  
Area Under The Curve ◽  
Postprandial Glucose ◽  
Moderate Intensity ◽  
Moderate Intensity Exercise ◽  
Obese Adults ◽  
High Intensity Interval ◽  
The Impact

The purpose of this study was to examine the impact of acute high-intensity interval training (HIIT) compared with continuous moderate-intensity (CMI) exercise on postprandial hyperglycemia in overweight or obese adults. Ten inactive, overweight or obese adults (41 ± 11 yrs, BMI = 36 ± 7 kg/m2) performed an acute bout of HIIT (10 × 1 min at approximately 90% peak heart rate (HRpeak) with 1-min recovery periods) or matched work CMI (30 min at approximately 65% HRpeak) in a randomized, counterbalanced fashion. Exercise was performed 2 h after breakfast, and glucose control was assessed by continuous glucose monitoring under standardized dietary conditions over 24 h. Postprandial glucose (PPG) responses to lunch, dinner, and the following day’s breakfast were analyzed and compared with a no-exercise control day. Exercise did not affect the PPG responses to lunch, but performing both HIIT and CMI in the morning significantly reduced the PPG incremental area under the curve (AUC) following dinner when compared with control (HIIT = 110 ± 35, CMI = 125 ± 34, control = 162 ± 46 mmol/L × 2 h, p < 0.05). The PPG AUC (HIIT = 125 ± 53, CMI = 186 ± 55, control = 194 ± 96 mmol/L × 2 h) and the PPG spike (HIIT = Δ2.1 ± 0.9, CMI = Δ3.0 ± 0.9, control = Δ3.0 ± 1.5 mmol/l) following breakfast on the following day were significantly lower following HIIT compared with both CMI and control (p < 0.05). Absolute AUC and absolute glucose spikes were not different between HIIT, CMI, or control for any meal (p > 0.05 for all). We conclude that a single session of HIIT has greater and more lasting effects on reducing incremental PPG when compared with CMI.

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