Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference

Andelin, Mervi; Kropff, Jort; Matuleviciene, Viktorija; Joseph, Jeffrey I.; Attvall, Stig; Theodorsson, Elvar; Hirsch, Irl B.; Imberg, Henrik; Dahlqvist, Sofia; Klonoff, David C.; Haraldsson, Börje; DeVries, J. Hans; Lind, Marcus

doi:10.1177/1932296815626724

Cited by 23 publications

(26 citation statements)

References 30 publications

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“…The accuracy of CGM and FGM sensors have been studied against frequently sampled venous and capillary blood. [ 12 15 16 ] In this study, the linear regression coefficient of AGP over RBS was 0.93 and that of AGP over CBG was 0.89 which is comparable to a recently published study evaluating the performance and usability of “FGM system” involving adults. [ 12 ] In our study, MARD for AGP over RBS was 9.56% and that of AGP over CBG was 15.07%.…”

Section: Discussionsupporting

confidence: 85%

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Evaluation of accuracy of ambulatory glucose profile in an outpatient setting in children with type 1 diabetes

Hulse¹,

Rai²,

Kumar³

2016

Indian J Endocr Metab

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Background:In children with type 1 diabetes, intensive diabetes management has been demonstrated to reduce long-term microvascular complications. At present, self-monitoring of blood glucose (SMBG) by patients at home and glycated hemoglobin estimation every 3 months are used to monitor glycemic control in children. Recently, ambulatory glucose profile (AGP) is increasingly being used to study the glycemic patterns in adults. However, accuracy and reliability of AGP in children have not been evaluated yet.Objectives:To assess the accuracy of AGP data in children with type 1 diabetes mellitus when compared with laboratory random blood sugar (RBS) levels, capillary blood glucose (CBG) measured by glucometer in the hospital, and SMBG monitored at home.Methods:Paired RBS, CBG, and AGP data were analyzed for 51 patients who wore AGP sensors for 2 weeks. Simultaneous venous and CBG samples were collected on day 1 and day 14. SMBG at home was checked and recorded by the patients for optimizing insulin doses. Accuracy measures (mean absolute deviation, mean absolute relative difference (MARD), and coefficient of linear regression of AGP on RBS, CBG, and home-monitored SMBG were calculated.Results:Seventy paired RBS, CBG, and AGP data and 362 paired home-monitored SMBG and AGP data were available. The MARD was 9.56% for AGP over RBS and 15.07% for AGP over CBG. The linear regression coefficient of AGP over RBS was 0.93 and that of AGP over CBG was 0.89 (P < 0.001). The accuracy of AGP over SMBG was evaluated over four ranges: <75, 76–140, 141–200, and >200 mg/dl.Conclusion:In this study, AGP data significantly correlate with RBS and CBG data in children with type 1 diabetes. However, a large number of samples in a research setting would help to document reproducibility of our results.

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Section: Discussionsupporting

confidence: 85%

“…[ 16 ] Other studies comparing various CGM devices have quoted similar numbers. [ 15 16 ] In this study, MARD was lower when AGP was compared to RBS than when it was compared to CBG.…”

Section: Discussionmentioning

confidence: 60%

Evaluation of accuracy of ambulatory glucose profile in an outpatient setting in children with type 1 diabetes

Hulse¹,

Rai²,

Kumar³

2016

Indian J Endocr Metab

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“…This would mean that the ISF glucose values are not of lower relevance than the BG values, but rather just the opposite. This, in turn, also means that the improvements observed over the last decade with the parameter used most often to characterize the analytical performance of CGM systems, 11,12 the mean (or median) absolute relative difference (MARD), will never be as low as when two BG measurement systems (system refers to the combination of the meter and the test strips) are compared. The MARD will reach a certain limit due to basic differences between the two measurement approaches (see above).…”

Section: Are the Differences Between Blood And Isf Glucose Levels Simmentioning

confidence: 99%

Discrepancies Between Blood Glucose and Interstitial Glucose—Technological Artifacts or Physiology: Implications for Selection of the Appropriate Therapeutic Target

Siegmund

Heinemann

Kolassa³

et al. 2017

J Diabetes Sci Technol

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Background: For decades, the major source of information used to make therapeutic decisions by patients with diabetes has been glucose measurements using capillary blood samples. Knowledge gained from clinical studies, for example, on the impact of metabolic control on diabetes-related complications, is based on such measurements. Different to traditional blood glucose measurement systems, systems for continuous glucose monitoring (CGM) measure glucose in interstitial fluid (ISF). The assumption is that glucose levels in blood and ISF are practically the same and that the information provided can be used interchangeably. Thus, therapeutic decisions, that is, the selection of insulin doses, are based on CGM system results interpreted as though they were blood glucose values. Methods: We performed a more detailed analysis and interpretation of glucose profiles obtained with CGM in situations with high glucose dynamics to evaluate this potentially misleading assumption. Results: Considering physical activity, hypoglycemic episodes, and meal-related differences between glucose levels in blood and ISF uncover clinically relevant differences that can make it risky from a therapeutic point of view to use blood glucose for therapeutic decisions. Conclusions: Further systematic and structured evaluation as to whether the use of ISF glucose is more safe and efficient when it comes to acute therapeutic decisions is necessary. These data might also have a higher prognostic relevance when it comes to long-term metabolic consequences of diabetes. In the long run, it may be reasonable to abandon blood glucose measurements as the basis for diabetes management and switch to using ISF glucose as the appropriate therapeutic target.

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“…However, CGM is expensive and not widely available due to limited reimbursement [18]. Moreover, CGM accuracy also remains a challenge; most of the available systems require calibration with capillary BG at least twice daily to allow a sufficiently reliable correlation between interstitial and capillary glucose results [19]. …”

Section: Introductionmentioning

confidence: 99%

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

et al. 2018

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Background/Aims: The FreeStyle® Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years in January 2016. Experience in children is still limited. We evaluated the accuracy and usability of the FGM in children with type 1 diabetes mellitus (DM). Methods: 67 children with type 1 DM (35 girls), aged 4–18 years, were included. Subjects wore a sensor on the back of their upper arm. For the first 14 days, they regularly measured capillary blood glucose (BG) with their usual BG meter (Accu-Chek® Mobile [ACM], Roche [n = 24]; Contour® Next Link [CNL], Bayer [n = 26]; OneTouch® Verio® IQ [OTV], LifeScan [n = 17]) followed by a sensor glucose (SG) scanning. SG readings were compared to BG measurements by consensus error grid (CEG) analysis; the mean difference (MD), the mean relative difference (MRD), the mean absolute difference (MAD), and the mean absolute relative difference (MARD) were calculated. After 14 days, subjects were asked to fill in a questionnaire on the usability of the FGM. Results: 2,626 SG readings were paired with BG results. FGM readings were highly correlated with BG (r = 0.926, p < 0.001). 80.3% of the data pairs were in zone A (= no effect on clinical action) and 18.4% were in zone B (= altered clinical action with little or no effect on the clinical outcome) of the CEG. Overall MD was +7.5 mg/dL; MD varied with the BG meter: ACM +10.4 mg/dL, CNL +14.2 mg/dL, OTV –3.6 mg/dL (p < 0.001). Overall, MARD was 16.7%. We observed a large interindividual variability in the accuracy parameters. MD and MRD were inversely related to BMI (r = –0.261 [p < 0.05]; r = –0.266 [p < 0.05], respectively). MARD was inversely related to age (r = –0.266 [p < 0.05]). Twenty-nine patients (43.3%) reported sensor problems, mainly early detachment of the sensor. Nonetheless, the usability questionnaire indicated high levels of satisfaction. Conclusions: Our results showed a reasonable agreement between the FGM SG readings and capillary BG measurements in children. There was, however, a large interindividual variability. The wearing of the sensor requires special attention. Further studies in children are imperative in order to document the accuracy and safety of the FGM in the paediatric population.

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Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference

Cited by 23 publications

References 30 publications

Evaluation of accuracy of ambulatory glucose profile in an outpatient setting in children with type 1 diabetes

Evaluation of accuracy of ambulatory glucose profile in an outpatient setting in children with type 1 diabetes

Discrepancies Between Blood Glucose and Interstitial Glucose—Technological Artifacts or Physiology: Implications for Selection of the Appropriate Therapeutic Target

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

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