{"title":"间歇性扫描连续血糖监测设备准确度下降与接触性皮炎的可能关系:ISCHIA研究的事后分析。","authors":"Masao Toyoda, Takashi Murata, Yushi Hirota, Kiminori Hosoda, Ken Kato, Kunichi Kouyama, Ryuji Kouyama, Akio Kuroda, Yuka Matoba, Munehide Matsuhisa, Shu Meguro, Junnosuke Miura, Kunihiro Nishimura, Akira Shimada, Shota Suzuki, Atsuhito Tone, Naoki Sakane","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>We previously reported the mean average relative difference (MARD) of the sensor glucose (SG) of the first-generation FreeStyle Libre with the original algorithm, an intermittent scanning continuous glucose monitoring (isCGM) device, was 15.6% in the Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study). In the present study, we aimed to further analyze its accuracy in detail by conducting a post-hoc analysis of the study.</p><p><strong>Methods: </strong>The ISCHIA Study was a multicenter, randomized, cross-over trial to assess the efficacy of isCGM. The SG levels of isCGM and the measured capillary blood glucose (BG) levels of 91 participants were used for the analysis.</p><p><strong>Results: </strong>Bland-Altman analysis showed bias of -13.0 mg/dl when the SG levels were compared to the BG levels, however no proportional bias was observed (<i>r</i> = 0.085). MARD of the participants without and with contact dermatitis were 15.0 ± 6.0% and 27.4 ± 21.4% (<i>P</i> = 0.001), respectively.</p><p><strong>Conclusion: </strong>There was negative bias in the SG levels of isCGM compared to the BG levels. There is a possibility that the complication of the contact dermatitis during isCGM use may be related with deteriorated accuracy of the SG levels.</p>","PeriodicalId":38819,"journal":{"name":"Tokai Journal of Experimental and Clinical Medicine","volume":"48 3","pages":"83-90"},"PeriodicalIF":0.0000,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Possible Relationship between the Deteriorated Accuracy of Intermittent-Scanning Continuous Glucose Monitoring Device and the Contact Dermatitis: Post-hoc analysis of the ISCHIA Study.\",\"authors\":\"Masao Toyoda, Takashi Murata, Yushi Hirota, Kiminori Hosoda, Ken Kato, Kunichi Kouyama, Ryuji Kouyama, Akio Kuroda, Yuka Matoba, Munehide Matsuhisa, Shu Meguro, Junnosuke Miura, Kunihiro Nishimura, Akira Shimada, Shota Suzuki, Atsuhito Tone, Naoki Sakane\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>We previously reported the mean average relative difference (MARD) of the sensor glucose (SG) of the first-generation FreeStyle Libre with the original algorithm, an intermittent scanning continuous glucose monitoring (isCGM) device, was 15.6% in the Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study). In the present study, we aimed to further analyze its accuracy in detail by conducting a post-hoc analysis of the study.</p><p><strong>Methods: </strong>The ISCHIA Study was a multicenter, randomized, cross-over trial to assess the efficacy of isCGM. The SG levels of isCGM and the measured capillary blood glucose (BG) levels of 91 participants were used for the analysis.</p><p><strong>Results: </strong>Bland-Altman analysis showed bias of -13.0 mg/dl when the SG levels were compared to the BG levels, however no proportional bias was observed (<i>r</i> = 0.085). MARD of the participants without and with contact dermatitis were 15.0 ± 6.0% and 27.4 ± 21.4% (<i>P</i> = 0.001), respectively.</p><p><strong>Conclusion: </strong>There was negative bias in the SG levels of isCGM compared to the BG levels. There is a possibility that the complication of the contact dermatitis during isCGM use may be related with deteriorated accuracy of the SG levels.</p>\",\"PeriodicalId\":38819,\"journal\":{\"name\":\"Tokai Journal of Experimental and Clinical Medicine\",\"volume\":\"48 3\",\"pages\":\"83-90\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Tokai Journal of Experimental and Clinical Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tokai Journal of Experimental and Clinical Medicine","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
Possible Relationship between the Deteriorated Accuracy of Intermittent-Scanning Continuous Glucose Monitoring Device and the Contact Dermatitis: Post-hoc analysis of the ISCHIA Study.
Objective: We previously reported the mean average relative difference (MARD) of the sensor glucose (SG) of the first-generation FreeStyle Libre with the original algorithm, an intermittent scanning continuous glucose monitoring (isCGM) device, was 15.6% in the Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study). In the present study, we aimed to further analyze its accuracy in detail by conducting a post-hoc analysis of the study.
Methods: The ISCHIA Study was a multicenter, randomized, cross-over trial to assess the efficacy of isCGM. The SG levels of isCGM and the measured capillary blood glucose (BG) levels of 91 participants were used for the analysis.
Results: Bland-Altman analysis showed bias of -13.0 mg/dl when the SG levels were compared to the BG levels, however no proportional bias was observed (r = 0.085). MARD of the participants without and with contact dermatitis were 15.0 ± 6.0% and 27.4 ± 21.4% (P = 0.001), respectively.
Conclusion: There was negative bias in the SG levels of isCGM compared to the BG levels. There is a possibility that the complication of the contact dermatitis during isCGM use may be related with deteriorated accuracy of the SG levels.
期刊介绍：
The Tokai Journal of Experimental and Clinical Medicine, also referred to as Tokai Journal, is an official quarterly publication of the Tokai Medical Association. Tokai Journal publishes original articles that deal with issues of clinical, experimental, socioeconomic, cultural and/or historical importance to medical science and related fields. Manuscripts may be submitted as full-length Original Articles or Brief Communications. Tokai Journal also publishes reviews and symposium proceedings. Articles accepted for publication in Tokai Journal cannot be reproduced elsewhere without written permission from the Tokai Medical Association. In addition, Tokai Journal will not be held responsible for the opinions of the authors expressed in the published articles.
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