1型糖尿病儿童应用快速扫描式葡萄糖监测系统的准确性及安全性
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摘要
目的:评估快速扫描式葡萄糖监测系统(FGMS)在14岁及以下1型糖尿病(T1DM)患儿中应用的准确性、安全性及满意度。方法:选择2017年8月至2018年2月于多家医院门诊治疗的14岁及以下T1DM患儿48例作为研究对象。所有受试者同时进行FGMS监测血糖及自我血糖监测(SMBG),分析FGMS的准确性。试验结束后填写使用感受及满意度调查问卷。结果:共收集FGMS与SMBG配对数据1 568对。Pearson相关系数显示,两者正相关(r=0.942,P<0.001)。总体FGMS与SMBG的平均相对误差绝对值(MARD)为14.23%[95%置信区间(CI) 13.64～14.89]。共识误差栅格分析显示,FGMS与SMBG的配对数据在A区和B区共占99.49%。有3例患儿的传感器提前脱落。FGMS使用满意度综合评分为4.43分。结论:FGMS在本地区T1DM儿童中应用的准确性、安全性及用户可接受性均较高,使用便捷,可减少患儿疼痛,且准确性不受受试者的特征影响。
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(T1 DM). Methods: From August 2017 to February 2018, 48 T1 DM 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 T1 DM 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.
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(T1 DM). Methods: From August 2017 to February 2018, 48 T1 DM 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 T1 DM 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.
引文
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[4]DANNE T, KORDONOURI O. Current challenges in children with type 1 diabetes[J]. Pediatr Diabetes, 2007,8(Suppl 6):3-5.
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[8]中华医学会糖尿病学分会血糖监测学组. 中国扫描式葡萄糖监测技术临床应用专家共识[J]. 中华糖尿病杂志, 2018,10(11):697-700.
[9]RAI S, HULSE A, KUMAR P. Feasibility and acceptability of ambulatory glucose profile in children with type 1 diabetes mellitus: a pilot study[J]. Indian J Endocrinol Metab, 2016, 20(6):790-794.
[10]GARG S K, AKTURK H K. Flash glucose monitoring: the future is here[J]. Diabetes Technol Ther, 2017,19(S2):S1-S3.
[11]BAILEY T, BODE B W, CHRISTIANSEN M P, et al. The performance and usability of a factory-calibrated flash glucose monitoring system[J]. Diabetes Technol Ther, 2015,17(11):787-794.
[12]óLAFSDóTTIR A F, ATTVALL S, SANDGREN U, et al. A clinical trial of the accuracy and treatment experience of the flash glucose monitor freestyle libre in adults with type 1 diabetes[J]. Diabetes Technol Ther, 2017,19(3):164-172.
[13]EDGE J, ACERINI C, CAMPBELL F, et al. An alternative sensor-based method for glucose monitoring in children and young people with diabetes[J]. Arch Dis Child, 2017,102(6):543-549.
[14]JI L, GUO X, GUO L, et al. A Multicenter evaluation of the performance and usability of a novel glucose monitoring system in chinese adults with diabetes[J]. J Diabetes Sci Technol, 2017,11(2):290-295.
[15]PARKES J L, SLATIN S L, PARDO S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose[J]. Diabetes Care, 2000,23(8):1143-1148.
[16]ZHOU J, ZHANG S, LI L, et al. Performance of a new real-time continuous glucose monitoring system: a multicenter pilot study[J]. J Diabetes Investig, 2018, 9(2):286-293.
[17]KENNETH W W. A review of the foreign-body response to subcutaneously-implanted devices: the role of macrophages and cytokines in biofouling and fibrosis[J]. J Diabetes Sci Technol, 2008, 2(5):768-777.
[18]SZADKOWSKA A, GAWRECKI A, MICHALAK A, et al. Flash glucose measurements in children with type 1 diabetes in real-life settings: to trust or not to trust?[J]. Diabetes Technol Ther, 2018,20(1):17-24.
[2]FU J F, LIANG L, GONG C X, et al. Status and trends of diabetes in Chinese children: analysis of data from 14 medical centers[J]. World J Pediatr, 2013,9(2):127-134.
[3]DANNE T. Flexibility of rapid-acting insulin analogues in children and adolescents with diabetes mellitus[J]. Clin Ther, 2007, 29 Suppl D:S145-S152.
[4]DANNE T, KORDONOURI O. Current challenges in children with type 1 diabetes[J]. Pediatr Diabetes, 2007,8(Suppl 6):3-5.
[5]American Diabetes Association. Standards of medical care in diabetes--2014[J]. Diabetes Care, 2014, 37(Suppl 1):S14-S80.
[6]WAGNER J, MALCHOFF C, ABBOTT G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes[J]. Diabetes Technol Ther, 2005,7(4):612-619.
[7]WHITTEMORE R, JASER S, CHAO A, et al. Psychological experience of parents of children with type 1 diabetes: a systematic mixed-studies review[J]. Diabetes Educ, 2012,38(4):562-579.
[8]中华医学会糖尿病学分会血糖监测学组. 中国扫描式葡萄糖监测技术临床应用专家共识[J]. 中华糖尿病杂志, 2018,10(11):697-700.
[9]RAI S, HULSE A, KUMAR P. Feasibility and acceptability of ambulatory glucose profile in children with type 1 diabetes mellitus: a pilot study[J]. Indian J Endocrinol Metab, 2016, 20(6):790-794.
[10]GARG S K, AKTURK H K. Flash glucose monitoring: the future is here[J]. Diabetes Technol Ther, 2017,19(S2):S1-S3.
[11]BAILEY T, BODE B W, CHRISTIANSEN M P, et al. The performance and usability of a factory-calibrated flash glucose monitoring system[J]. Diabetes Technol Ther, 2015,17(11):787-794.
[12]óLAFSDóTTIR A F, ATTVALL S, SANDGREN U, et al. A clinical trial of the accuracy and treatment experience of the flash glucose monitor freestyle libre in adults with type 1 diabetes[J]. Diabetes Technol Ther, 2017,19(3):164-172.
[13]EDGE J, ACERINI C, CAMPBELL F, et al. An alternative sensor-based method for glucose monitoring in children and young people with diabetes[J]. Arch Dis Child, 2017,102(6):543-549.
[14]JI L, GUO X, GUO L, et al. A Multicenter evaluation of the performance and usability of a novel glucose monitoring system in chinese adults with diabetes[J]. J Diabetes Sci Technol, 2017,11(2):290-295.
[15]PARKES J L, SLATIN S L, PARDO S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose[J]. Diabetes Care, 2000,23(8):1143-1148.
[16]ZHOU J, ZHANG S, LI L, et al. Performance of a new real-time continuous glucose monitoring system: a multicenter pilot study[J]. J Diabetes Investig, 2018, 9(2):286-293.
[17]KENNETH W W. A review of the foreign-body response to subcutaneously-implanted devices: the role of macrophages and cytokines in biofouling and fibrosis[J]. J Diabetes Sci Technol, 2008, 2(5):768-777.
[18]SZADKOWSKA A, GAWRECKI A, MICHALAK A, et al. Flash glucose measurements in children with type 1 diabetes in real-life settings: to trust or not to trust?[J]. Diabetes Technol Ther, 2018,20(1):17-24.