Murray-Bachmann Renee, Leung Tung Ming, Myers Alyson K, Murthi Swetha, Sarbanes Mulugeta, Ziskovich Karina, Lesser Martin, Poretsky Leonid
Department of Nursing, Lenox Hill Hospital, Northwell Health, New York, NY, USA.
Biostatistics Unit - Feinstein Institutes for Medical Research, Northwell Health, Great Neck, New York, USA.
J Clin Transl Endocrinol. 2021 Jul 7;25:100262. doi: 10.1016/j.jcte.2021.100262. eCollection 2021 Sep.
AIMS/HYPOTHESIS: Hyperglycemia and hypoglycemia are associated with increased morbidity and mortality in the inpatient setting. Standard point of care capillary glucose testing (POCT) is commonly used in hospitalized patients to monitor their glucose levels. The goal of this study was to examine the relationships between the glucose readings obtained by a continuous glucose monitoring system (CGMS) (Freestyle Libre) and the capillary blood glucose results obtained by the inpatient glucose POCT meter (Accuchek Inform II) as well as between CGMS readings and the serum glucose values obtained by the hospital laboratory. Study participants had either primary or secondary diagnosis of diabetes mellitus and were admitted to non-critical units. We hypothesized that there exists an acceptable agreement between the capillary blood glucose results obtained by the inpatient glucose POCT meter (Accuchek Inform II) and the readings obtained by the CGMS (Freestyle Libre); and that there exists an acceptable agreement between the serum glucose levels and the glucose values obtained by the CGMS. METHODS: This was an Institutional Review Board approved prospective cohort study for the non- critical inpatient setting. Fifty-two hospitalized patients with diabetes were recruited. After informed consent was obtained, patients were instructed on the application and use of the CGMS. The data were assessed using a standard regression analysis and modified Bland Altman analysis. All analyses were conducted using SAS, release 3.8 Enterprise Edition (SAS Institute Inc., Cary, NC). RESULTS: Fifty-two subjects recruited into the study represented a sample of convenience. There were a total of 467 AccuChek-Libre pairs, The regression analysis showed a negative bias between.Libre and AccuChek, R = 0.83, with Libre glucose readings on average being lower than those of AccuChek. Using Bland-Altman analysis, 42% of the 467 Libre-AccuChek pairs had a difference in glucose reading more than 15%. Mean absolute relative difference (MARD) between Libre and AccuChek was 15.6%; mean relative difference (MRD) between Libre and AccuChek was -11.4%.The regression analysis showed a negative bias between Libre and serum glucose, R = 0.89. Using Bland Altman analysis, 36% of the 44 Libre-serum pairs had a difference in glucose reading more than 15%. Mean absolute relative difference (MARD) between Libre and serum glucose was 13.2%; mean relative difference (MRD) between Libre and serum glucose was -12.5%.A review of the data pairs showed that 71/467 Accuchek-Libre pairs had one result that was either below 70 mg/dl or above 200 mg/dl (combined American Diabetes Association-ADA-, American College of Physicians-ACP- and American College of Endocrinology-AACE- goals). Thus 85%, of these pairs would have yielded results that engendered the same intervention (e.g. treatment for hypoglycemia or hyperglycemia). Likewise 5/45 Serum-Libre pairs had one result that was either below 70 mg/dl or above 200 mg/dl; thus 89% of these pairs would have yielded results requiring the same intervention. CONCLUSION/INTERPRETATION: These findings confirm the existent literature and indicate acceptable agreement between the standard POCT and the CGMS as well as between serum glucose and the CGMS values. Because of the advantages of the CGMS over capillary blood glucose testing (reduced patient discomfort and reduced staff exposure to patients in isolation) CGMS use may be preferable to the current bedside capillary blood glucose testing in hospitalized patients with diabetes mellitus. As with other laboratory measures, clinical judgement needs to be exercised when the laboratory values are used to guide patient care.
目的/假设:在住院环境中,高血糖和低血糖与发病率和死亡率增加相关。标准的即时护理毛细血管血糖检测(POCT)常用于住院患者以监测其血糖水平。本研究的目的是检验通过连续血糖监测系统(CGMS)(Freestyle Libre)获得的血糖读数与住院患者血糖POCT血糖仪(Accuchek Inform II)获得的毛细血管血糖结果之间的关系,以及CGMS读数与医院实验室获得的血清葡萄糖值之间的关系。研究参与者患有原发性或继发性糖尿病,且入住非重症病房。我们假设住院患者血糖POCT血糖仪(Accuchek Inform II)获得的毛细血管血糖结果与CGMS(Freestyle Libre)获得的读数之间存在可接受的一致性;并且血清葡萄糖水平与CGMS获得的血糖值之间存在可接受的一致性。 方法:这是一项经机构审查委员会批准的针对非重症住院患者的前瞻性队列研究。招募了52名住院糖尿病患者。在获得知情同意后,指导患者使用CGMS。使用标准回归分析和改良的布兰德-奥特曼分析对数据进行评估。所有分析均使用SAS 3.8企业版(SAS Institute Inc.,北卡罗来纳州卡里)进行。 结果:招募到的52名受试者是一个便利样本。共有467对AccuChek-Libre数据对。回归分析显示Libre与AccuChek之间存在负偏差,R = 0.83,Libre血糖读数平均低于AccuChek。使用布兰德-奥特曼分析,467对Libre-AccuChek数据对中有42%的血糖读数差异超过15%。Libre与AccuChek之间的平均绝对相对差异(MARD)为15.6%;Libre与AccuChek之间的平均相对差异(MRD)为-11.4%。回归分析显示Libre与血清葡萄糖之间存在负偏差,R = 0.89。使用布兰德-奥特曼分析,44对Libre-血清数据对中有36%的血糖读数差异超过15%。Libre与血清葡萄糖之间的平均绝对相对差异(MARD)为13.2%;Libre与血清葡萄糖之间的平均相对差异(MRD)为-12.5%。对数据对的审查显示,467对Accuchek-Libre数据对中有71对的一个结果低于70mg/dl或高于200mg/dl(美国糖尿病协会-ADA-、美国医师协会-ACP-和美国内分泌学会-AACE-的综合目标)。因此,这些数据对中有85%会得出需要相同干预措施(如低血糖或高血糖治疗)的结果。同样,45对血清-Libre数据对中有5对的一个结果低于70mg/dl或高于200mg/dl;因此,这些数据对中有89%会得出需要相同干预措施的结果。 结论/解读:这些发现证实了现有文献,并表明标准POCT与CGMS之间以及血清葡萄糖与CGMS值之间存在可接受的一致性。由于CGMS相对于毛细血管血糖检测具有优势(减少患者不适以及减少工作人员与隔离患者的接触),对于住院糖尿病患者,使用CGMS可能比目前的床边毛细血管血糖检测更可取。与其他实验室检测一样,当使用实验室值指导患者护理时,需要运用临床判断。
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