Bode Bruce W, Schwartz Sherwyn, Stubbs Harrison A, Block Jon E
Atlanta Diabetes Associates, Georgia, USA.
Diabetes Care. 2005 Oct;28(10):2361-6. doi: 10.2337/diacare.28.10.2361.
The purpose of this study was to generate normative values for periods of euglycemia as well as for daily patterns of glycemic excursions in patients with type 1 and type 2 diabetes monitored continuously for a maximum period of 21 days and blinded to glucose levels.
This was a multicenter, prospective observational study in which 101 consecutive patients with type 1 (n = 60) or type 2 (n = 41) diabetes underwent blinded continuous glucose monitoring. Serial glucose measurements were divided into periods of euglycemia (70-180 mg/dl), hyperglycemia (>180 mg/dl), and hypoglycemia (<70 mg/dl). The proportions of time patients were hypoglycemic, euglycemic, and hyperglycemic and the total areas under the curves (AUCs) were determined.
During the observation period the 101 subjects contributed an average 287 +/- 132 h of continuous glucose values. Subjects remained in the euglycemic range for approximately 63% of the total day, were hypoglycemic 8%, and were hyperglycemic 29%. Hypoglycemia was more prevalent nocturnally (11 vs. 7%) and hyperglycemia diurnally (31 vs. 25%). Compared with subjects with type 2 diabetes, type 1 diabetic subjects had more frequent hypoglycemic episodes per day (2.1 vs. 1.0; P < 0.001) that were of longer duration (1.1 vs. 0.7 h; P < 0.0001), reflecting a greater number of hours per day in the hypoglycemic range (2.3 vs. 1.0 h; P < 0.0001). The mean hypoglycemic AUC values were >150% higher for type 1 compared with type 2 diabetic subjects (41 vs. 16, respectively; P < 0.0001).
These normative data will assist in study and sample size planning for future investigations of continuous glucose monitoring and allow for qualitative comparisons with trials of therapeutic interventions aimed at reducing the occurrence of glycemic excursions.
本研究旨在为1型和2型糖尿病患者生成血糖正常期以及血糖波动日常模式的标准值，这些患者连续监测最长21天且对血糖水平不知情。
这是一项多中心前瞻性观察性研究，101例连续的1型糖尿病患者（n = 60）或2型糖尿病患者（n = 41）接受了不知情的连续血糖监测。连续血糖测量值分为血糖正常期（70 - 180 mg/dl）、高血糖期（>180 mg/dl）和低血糖期（<70 mg/dl）。确定患者处于低血糖、血糖正常和高血糖状态的时间比例以及曲线下总面积（AUC）。
在观察期内，101名受试者提供了平均287±132小时的连续血糖值。受试者全天约63%的时间处于血糖正常范围，8%的时间处于低血糖状态，29%的时间处于高血糖状态。低血糖在夜间更为普遍（11%对7%），高血糖在白天更为普遍（31%对25%）。与2型糖尿病患者相比，1型糖尿病患者每天低血糖发作更频繁（2.1次对1.0次；P < 0.001），持续时间更长（1.1小时对0.7小时；P < 0.0001），这反映出每天处于低血糖范围的小时数更多（2.3小时对1.0小时；P < 0.0001）。1型糖尿病患者的平均低血糖AUC值比2型糖尿病患者高>150%（分别为41对16；P < 0.0001）。
这些标准数据将有助于未来连续血糖监测研究的研究设计和样本量规划，并允许与旨在减少血糖波动发生的治疗干预试验进行定性比较。
