Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors

Bailey, Timothy S.

doi:10.1089/dia.2017.0050

Cited by 47 publications

(33 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The MARD (mean absolute relative difference) and MAD (mean absolute difference) between the tested system and the reference system have been emerged as the preferred metric to assess sensor accuracy [36]. In our study the overall MARD was 16.7%, and was comparable between the used BG meters.…”

Section: Discussionsupporting

confidence: 55%

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

et al. 2018

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 55%

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

et al. 2018

View full text Add to dashboard Cite

show abstract

“…There are no consensus guidelines for the best metric by which to assess the accuracy of real‐time CGM and flash glucose monitoring devices. As a result, a variety have been used, the majority of which are affected by glucose excursions, therefore, comparing across studies may lead to misleading conclusions . Ideally different sensors should be compared in the same individual exposed to same glucose fluctuations.…”

Section: Real‐world Use Of Freestyle Librementioning

confidence: 99%

“…Replacing the sensor every 14 days, compared to every 6 or 7 days can reduce the 'diabetes burden' associated with the number of tasks needed for diabetes Once placed on the skin, FreeStyle Libre cannot be moved for 14 days which may limit clothing options for some who prefer to have the device hidden from view. A minority will experience skin reactions to the FreeStyle Libre or sensor may fall off before 14 days ª 2018 Diabetes UK excursions, therefore, comparing across studies may lead to misleading conclusions [25]. Ideally different sensors should be compared in the same individual exposed to same glucose fluctuations.…”

Section: Day Wearmentioning

confidence: 99%

Flash forward: a review of flash glucose monitoring

2018

View full text Add to dashboard Cite

The FreeStyle Libre flash glucose monitor became available on prescription (subject to local health authority approval) in all four nations of the UK from November 2017, a watershed moment in the history of diabetes care. Calibration free, the FreeStyle Libre is a disc worn on the arm for 14 days which is designed largely to replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of diabetes. This review discusses clinical data from randomized and observational studies, considers device accuracy metrics and deliberates its popularity and the potential challenges that this new device brings to diabetes care in the UK. In randomized trials, FreeStyle Libre use is associated with a reduction in hypoglycaemia and, in observational studies, improvements in HbA levels. User satisfaction is high and adverse events are low. Accuracy of the FreeStyle Libre is comparable to currently available real-time continuous glucose monitors in adults, children and during pregnancy; the cost of the FreeStyle Libre is lower. Glucose data can be visualized in multiple devices and platforms, and summarized in an ambulatory glucose profile to aid pattern recognition and insulin dose adjustment. There is a need for appropriate education, of both users and healthcare professionals, to harness the full benefits. Further randomized studies to assess the long-term impact on HbA , particularly in those with high baseline HbA and in specific age groups, such as adolescents and young adults, are warranted. The potential impact on complications, is yet to be realized.

show abstract

“…In 1999, the first commercial CGM system had a MARD of 26% (48), whereas the MARD of currently available sensors ranges from 9.0% without any calibration for the Dexcom G6 and 9.4% for the Freestyle Libre, to 9.6% for the Medtronic Guardian with three to four daily calibrations (30,(49)(50)(51). It should be noted, however, that the MARD value is impacted by many factors beyond the accuracy of the sensor, including: the glucose concentration, the absolute number of data points, the rate of glucose change, intensive exercise, and missing data points (52)(53)(54). Therefore, different studies have resulted in different MARD values for the same device (55).…”

Section: Cgm Accuracymentioning

confidence: 99%

Monitoring of Pediatric Type 1 Diabetes

Marks

Wolfsdorf

2020

Front. Endocrinol.

View full text Add to dashboard Cite

Regular self-monitoring of blood glucose levels, and ketones when indicated, is an essential component of type 1 diabetes (T1D) management. Although fingerstick blood glucose monitoring has been the standard of care for decades, ongoing rapid technological developments have resulted in increasingly widespread use of continuous glucose monitoring (CGM). This article reviews recommendations for self-monitoring of glucose and ketones in pediatric T1D with particular emphasis on CGM and factors that impact the accuracy and real-world use of this technology.

show abstract

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors

Cited by 47 publications

References 35 publications

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

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

Flash forward: a review of flash glucose monitoring

Monitoring of Pediatric Type 1 Diabetes

Contact Info

Product

Resources

About