Senior Resident, Department of Medicine, SMS Medical College & Hospital, Jaipur, Rajasthan, India.
Assistant Professor, Department of Medicine, SMS Medical College & Hospital, Jaipur, Rajasthan, India.
J Assoc Physicians India. 2024 Jan;72(1):18-21. doi: 10.59556/japi.71.0441.
INTRODUCTION: The world has changed tremendously for patients suffering from diabetes mellitus with the development of cutting-edge technologies like continuous glucose monitoring and flash glucose monitoring systems. Now, the details of constant fluctuations of glucose in their blood can be monitored not only by medical professionals but also by patients, and this is called glycemic variability (GV). Traditional metrics of glycemic control measurement, such as glycated hemoglobin (HbA1c), fail to reflect various short-term glycemic changes like postprandial hyperglycemia and hypoglycemic episodes, paving the way to the occurrence of various diabetic complications even in asymptomatic, well-controlled diabetic patients. This need for advanced management of diabetes and effective monitoring of these swings in blood glucose can be met by using a continuous glucose monitoring system (CGMS). AIM AND OBJECTIVE: To evaluate the extent of GV in well-controlled type 2 diabetes mellitus (T2DM) patients using a flash CGMS and to assess the correlation between GV and HbA1c. MATERIALS AND METHODS: A hospital-based prospective observational study was carried out from May 2020 to Oct 2021 at the Department of Medicine, SMS Hospital, Jaipur, Rajasthan (India), after approval from the Ethics Committee of the institution. A total of 30 patients with well-controlled T2DM (HbA1c was ≥6.5, but ≤7.5 were included in the study using simple random techniques after written informed consent from patients. Patients were studied for glycemic excursions over a period of 7 days by using FreeStyle Libre Pro™, which is a flash glucose monitoring system. The CGM sensor was attached to the left upper arm of the patient on day 0 and removed on day 7. The data recorded in the sensor was then retrieved using pre-installed computer software and analyzed using standard CGM metrics like standard deviation (SD), percentage coefficient of variation (%CV), time above range (TAR), time below range (TBR), and time in range (TIR), out of which %CV was used to quantify GV. %CV has been used to cluster patients into four cohorts from best to worst, namely: best/low CV ≤ 10%, intermediate CV from 10 to 20%, high CV from 20 to 30%, and very high CV of >30%. Scatterplots are used to establish correlations between various parameters. RESULT: Data from a total of 30 patients were analyzed using CGMS and thus used for calculating standard CGM metrics; glucose readings every 15 minutes were recorded consecutively for 7-day periods, making it a total of 672 readings for each patient. Interpreting the CGM data of all 30 patients, the following results were found: the mean blood glucose of all cases is 134.925 ± 22.323 mg/dL, the mean SD of blood glucose of all cases is 35.348 ± 9.388 mg/dL, the mean of %CV of all cases is 26.376 ± 6.193%. CGM parameters of time are used in the form of percentages, and the following results were found: the mean of TAR, TBR, and TIR is 14.425 ± 13.211, 5.771 ± 6.808, and 82.594 ± 12.888%, respectively. Clustering the patients into cohorts, the proportion of patients exhibiting best/low %CV (10%) is 0, intermediate %CV (10-20%) is 16.67% (five out of 30 patients), high %CV (20-30%) is 50% (15 out of 30 patients) and very high %CV (>30%) is 33.33% (10 out of 30 patients). Also, there is no significant correlation found between HbA1c and %CV ( = 0.076, -value = 0.690); a significant negative correlation was found between %CV and TIR ( = -0.604, < 0.001S); a positive correlation of %CV with TAR and TBR is significant ( = 0.816, -value of <0.001). CONCLUSION: Using a flash CGMS device and considering %CV as the parameter and primary measure of GV, the study demonstrated the overall instability of a person's glycemic control, making note of unrecognized events of hypoglycemia and hyperglycemia in asymptomatic well-controlled T2DM patients, revealing the overall volatile glycemic control. The most important finding of this study is that even those diabetics who are considered well-controlled experience a great degree of GV as assessed by CGM-derived metrics. This study also demonstrated that there is no significant correlation between HbA1c and GV, suggesting that patients may not have optimal control of their diabetes despite having "normal HbA1c" values; hence, GV can be considered an HbA1c-independent danger factor, having more harmful effects than sustained hyperglycemia in the growth of diabetic complications. So, by using CGM-derived metrics, the measurement of GV has the potential to complement HbA1c data. In this manner, a more comprehensive assessment of glycemic excursions can be provided for better treatment decisions, thereby facilitating optimal glycemic control, which is essential for reducing overall complications and promoting good quality of life.
简介:随着连续血糖监测和闪速血糖监测系统等先进技术的发展,糖尿病患者的世界发生了巨大变化。现在,不仅可以通过医疗专业人员,还可以通过患者监测到血液中葡萄糖的不断波动,这被称为血糖变异性(GV)。传统的血糖控制测量指标,如糖化血红蛋白(HbA1c),无法反映餐后高血糖和低血糖发作等各种短期血糖变化,这为无症状、控制良好的糖尿病患者发生各种糖尿病并发症铺平了道路。这种对糖尿病的高级管理和对这些血糖波动的有效监测,可以通过使用连续血糖监测系统(CGMS)来实现。
目的和目标:使用闪速 CGMS 评估控制良好的 2 型糖尿病(T2DM)患者的 GV 程度,并评估 GV 与 HbA1c 之间的相关性。
材料和方法:这项在印度拉贾斯坦邦斋浦尔 SMS 医院内科进行的基于医院的前瞻性观察性研究于 2020 年 5 月至 2021 年 10 月进行,在获得机构伦理委员会的批准后,使用简单随机技术从 30 名 HbA1c 水平≥6.5、但≤7.5的控制良好的 T2DM 患者中纳入研究。使用 FreeStyle Libre ProTM 通过 7 天的时间监测患者的血糖波动,这是一种闪速血糖监测系统。在第 0 天将 CGM 传感器贴在患者的左上臂上,第 7 天取下。然后使用预安装的计算机软件检索传感器中记录的数据,并使用标准 CGMS 指标(如标准差(SD)、百分变异系数(%CV)、高于范围时间(TAR)、低于范围时间(TBR)和范围内时间(TIR))进行分析,其中%CV 用于量化 GV。%CV 用于将患者分为四个队列,从最好到最差:最佳/低 CV≤10%、中间 CV 为 10%至 20%、高 CV 为 20%至 30%和非常高 CV>30%。散点图用于建立各参数之间的相关性。
结果:对使用 CGMS 获得的 30 名患者的数据进行分析,从而计算标准 CGMS 指标;连续 7 天每 15 分钟记录一次血糖读数,每个患者共记录 672 次读数。对所有 30 名患者的 CGM 数据进行解释,结果如下:所有病例的平均血糖为 134.925±22.323mg/dL,所有病例的平均血糖 SD 为 35.348±9.388mg/dL,所有病例的平均%CV 为 26.376±6.193%。CGM 时间参数以百分比的形式表示,结果如下:TAR、TBR 和 TIR 的平均值分别为 14.425±13.211%、5.771±6.808%和 82.594±12.888%。将患者分为队列,表现出最佳/低%CV(10%)的患者比例为 0,中间%CV(10-20%)的患者比例为 16.67%(30 名患者中有 5 名),高%CV(20-30%)的患者比例为 50%(30 名患者中有 15 名),非常高%CV(>30%)的患者比例为 33.33%(30 名患者中有 10 名)。此外,HbA1c 与%CV 之间没有发现显著相关性( = 0.076,-值= 0.690);%CV 与 TIR 之间存在显著负相关( = -0.604,<0.001S);%CV 与 TAR 和 TBR 的正相关具有显著意义( = 0.816,-值<0.001)。
结论:使用闪速 CGMS 设备并考虑%CV 作为 GV 的参数和主要衡量标准,该研究表明患者血糖控制的总体不稳定,在无症状、控制良好的 T2DM 患者中注意到未被识别的低血糖和高血糖事件,揭示了整体不稳定的血糖控制。本研究的一个重要发现是,即使那些被认为控制良好的糖尿病患者也会经历很大程度的 GV,这是通过 CGM 衍生的指标评估的。本研究还表明,HbA1c 与 GV 之间没有显著相关性,这表明尽管患者的 HbA1c 值正常,但他们可能没有得到最佳的糖尿病控制;因此,GV 可以被视为 HbA1c 之外的一个危险因素,在糖尿病并发症的发展中,其造成的危害比持续高血糖更大。因此,通过使用 CGM 衍生的指标,可以补充 HbA1c 数据进行 GV 的测量。通过这种方式,可以为更好的治疗决策提供更全面的血糖波动评估,从而促进更好的血糖控制,这对于降低整体并发症和提高生活质量至关重要。
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