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Accuracy and safety evaluation of flash glucose monitoring system for children with type 1 diabetes
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Citation of this paper:HU Ke-yan1,2, MA Yu-jin1,2, LI Li-ping1,2, FU Liu-jun1,2, LIU Jie1,2, BAI Jin-lei1,2, WANG Jun-hong3, TIAN De-zeng4, ZHAO Ju-zhen5, WANG Rui-li1, JIANG Hong-wei1,2*, WANG Hong-yun1*.Accuracy and safety evaluation of flash glucose monitoring system for children with type 1 diabetes[J].Chinese Journal of Clinical Medicine,2019,26(1):19-23
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Author NameAffiliation
HU Ke-yan1,2, MA Yu-jin1,2, LI Li-ping1,2, FU Liu-jun1,2, LIU Jie1,2, BAI Jin-lei1,2, WANG Jun-hong3, TIAN De-zeng4, ZHAO Ju-zhen5, WANG Rui-li1, JIANG Hong-wei1,2*, WANG Hong-yun1* 1. Clinical Medicine School, Department of Endocrinology, the First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, Henan, China 2.Institute of Clinical Research for Endocrine and Metabolic Diseases of Luoyang, Luoyang 471000, Henan, China 3.Department of Endocrinology and Metabolism, the First People’s Hospital of Pingdingshan, Pingdingshan 467000, Henan, China 4.Department of Endocrinology, Anyang District Hospital, Anyang 455000, Henan, China 5.Department of Endocrinology, the People’s Hospital of Jiaozuo, Jiaozuo 454150, Henan, China 
Abstract:Objective:To evaluate the accuracy, safety, and satisfaction of the flash glucose monitoring system (FGMS) in patients under 14 years old (including 14 years old) with type 1 diabetes (T1DM). Methods:From August 2017 to February 2018, 48 T1DM outpatients aged under 14 years (including 14 years old) were selected from several hospitals. All subjects simultaneously underwent FGMS monitoring and self-monitoring of blood glucose (SMBG). The accuracy of FGMS was analyzed. At the end of the experiment, the questionnaire survey of the using feelings and satisfaction was performed. Results:A total of 1 568 pairs of FGMS and SMBG matched values were collected. Pearson correlation analysis showed a positive correlation between the two methods (r=0.942,P<0.001). The overall MARD of FGMS and SMBG was 14.23% (95%CI 13.64-14.89). The consensus error grid analysis showed that the ratio of FGMS and SMBG matched values in A and B areas was 99.49%. There were 3 cases of sensors fell off in advance during the research. The satisfaction score of FGMS was 4.43. Conclusions:The accuracy, safety, and satisfaction of FGMS in children with T1DM in this region are relatively high. The system is easy to use and could reduce the pain of patients, and its accuracy would not be affected by the characteristics of the subjects.
keywords:type 1 diabetes mellitus  children  flash glucose monitoring system  accuracy
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