Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital
ObjectivesBased on FreeStyle Libre, we designed QT AIR, an advanced real-time, calibrated Continuous Glucose Monitoring (CGM) device. This study aim to validate the consistency and clinical accuracy of the product by comparing the capillary blood glucose (CBG) with CGM data in both in-hospital and o...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fendo.2025.1466358/full |
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| author | Zhenghao Wu Zhenghao Wu Zhaoxiang Liu Wenhui Zhao Shaocheng Wang Liangbiao Gu Jianzhong Xiao |
| author_facet | Zhenghao Wu Zhenghao Wu Zhaoxiang Liu Wenhui Zhao Shaocheng Wang Liangbiao Gu Jianzhong Xiao |
| author_sort | Zhenghao Wu |
| collection | DOAJ |
| description | ObjectivesBased on FreeStyle Libre, we designed QT AIR, an advanced real-time, calibrated Continuous Glucose Monitoring (CGM) device. This study aim to validate the consistency and clinical accuracy of the product by comparing the capillary blood glucose (CBG) with CGM data in both in-hospital and outpatient scenarios.MethodsResults of CGM devices were compared with random capillary glucose values from users in both in-hospital and outpatient settings. The accuracy of CGMs was assessed through consistency analysis, Bland-Altman analysis, calculation of MARD and MAD, Consensus Error Grids, as well as analysis using the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA).ResultsIn outpatient setting, 1907 values from 138 users were analyzed. FreeStyle Libre data, QT AIR calibrated and uncalibrated data showed strong positive correlations with capillary blood glucose values. The MARD values for the FreeStyle Libre, uncalibrated QT AIR, and calibrated QT AIR groups were 18.33%, 20.63%, and 12.39%, respectively. Consensus Error Grid, reference values in Zone A: FreeStyle Libre: 69.75%, QT AIR uncalibrated: 67.80%, QT AIR calibrated: 87.62%. The Bland-Altman analysis results suggest that FreeStyle Libre exhibitsed a systematic underestimation of blood glucose levels, while QT AIR almost rectified the differences. In the in-Hospital setting, the MARD of QT AIR after calibration was reduced to 7.24%. The Consensus error grid analyses of the in-Hospital data revealed that 95% of the calibrated QT AIR values fell within Zone A, a significantly higher proportion than that of other two group. The CG-DIVA analysis of the calibrated QT AIR device showed a median bias of -0.49% and a between-sensor variability of 26.65%, both of which are significantly lower than the corresponding values observed for the FreeStyle Libre device.ConclusionsWe successfully transformed a retrospective CGM system into a real-time monitoring device. The monitoring accuracy of the device could be improved by calibration. |
| format | Article |
| id | doaj-art-3e96f75412274ce8ac4f792b8a168305 |
| institution | OA Journals |
| issn | 1664-2392 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Endocrinology |
| spelling | doaj-art-3e96f75412274ce8ac4f792b8a1683052025-08-20T02:24:34ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922025-04-011610.3389/fendo.2025.14663581466358Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospitalZhenghao Wu0Zhenghao Wu1Zhaoxiang Liu2Wenhui Zhao3Shaocheng Wang4Liangbiao Gu5Jianzhong Xiao6Department of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaDepartment of Endocrinology, The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou Peoples Hospital, Quzhou, Zhejiang, ChinaDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaDepartment of Endocrinology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, ChinaObjectivesBased on FreeStyle Libre, we designed QT AIR, an advanced real-time, calibrated Continuous Glucose Monitoring (CGM) device. This study aim to validate the consistency and clinical accuracy of the product by comparing the capillary blood glucose (CBG) with CGM data in both in-hospital and outpatient scenarios.MethodsResults of CGM devices were compared with random capillary glucose values from users in both in-hospital and outpatient settings. The accuracy of CGMs was assessed through consistency analysis, Bland-Altman analysis, calculation of MARD and MAD, Consensus Error Grids, as well as analysis using the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA).ResultsIn outpatient setting, 1907 values from 138 users were analyzed. FreeStyle Libre data, QT AIR calibrated and uncalibrated data showed strong positive correlations with capillary blood glucose values. The MARD values for the FreeStyle Libre, uncalibrated QT AIR, and calibrated QT AIR groups were 18.33%, 20.63%, and 12.39%, respectively. Consensus Error Grid, reference values in Zone A: FreeStyle Libre: 69.75%, QT AIR uncalibrated: 67.80%, QT AIR calibrated: 87.62%. The Bland-Altman analysis results suggest that FreeStyle Libre exhibitsed a systematic underestimation of blood glucose levels, while QT AIR almost rectified the differences. In the in-Hospital setting, the MARD of QT AIR after calibration was reduced to 7.24%. The Consensus error grid analyses of the in-Hospital data revealed that 95% of the calibrated QT AIR values fell within Zone A, a significantly higher proportion than that of other two group. The CG-DIVA analysis of the calibrated QT AIR device showed a median bias of -0.49% and a between-sensor variability of 26.65%, both of which are significantly lower than the corresponding values observed for the FreeStyle Libre device.ConclusionsWe successfully transformed a retrospective CGM system into a real-time monitoring device. The monitoring accuracy of the device could be improved by calibration.https://www.frontiersin.org/articles/10.3389/fendo.2025.1466358/fullrtCGMcontinuous glucose monitoringaccuracyFreeStyle librecalibrate |
| spellingShingle | Zhenghao Wu Zhenghao Wu Zhaoxiang Liu Wenhui Zhao Shaocheng Wang Liangbiao Gu Jianzhong Xiao Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital Frontiers in Endocrinology rtCGM continuous glucose monitoring accuracy FreeStyle libre calibrate |
| title | Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital |
| title_full | Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital |
| title_fullStr | Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital |
| title_full_unstemmed | Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital |
| title_short | Accuracy of a novel calibratable real-time continuous glucose monitoring device based on FreeStyle libre in- and out-of-hospital |
| title_sort | accuracy of a novel calibratable real time continuous glucose monitoring device based on freestyle libre in and out of hospital |
| topic | rtCGM continuous glucose monitoring accuracy FreeStyle libre calibrate |
| url | https://www.frontiersin.org/articles/10.3389/fendo.2025.1466358/full |
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