Mazze R S, Shamoon H, Pasmantier R, Lucido D, Murphy J, Hartmann K, Kuykendall V, Lopatin W
Am J Med. 1984 Aug;77(2):211-7. doi: 10.1016/0002-9343(84)90693-4.
Nineteen patients with insulin-dependent diabetes mellitus were evaluated for overall reliability of self-generated data from capillary blood glucose monitoring. For a period of 12 to 14 days, standard reflectance meters used by these subjects were replaced by meters internally modified with memory chips capable of storing all glucose readings by date and time. The subjects were not aware of this modification and were instructed to continue to test capillary blood glucose as they had been and to continue their practice of recording the meter readings in a logbook. To assess reliability of patient-generated data as recorded in the logbook, the addition, deletion, and alteration of test results were determined. A significantly lower (p less than 0.0001) mean blood glucose level was reported in the logbooks than recorded in the memory reflectance meters. Differences in logbooks and memory reflectance meters ranged from 0 to 109 mg/dl. Three fourths of the subjects had reported lower than actual mean blood glucose values. Under-reporting, or omission of memory reflectance meter readings, averaged 10 percent, whereas over-reporting or addition of phantom values averaged 40 percent. An average of 26 percent of the logbook entries were not identical to memory reflectance meter values determined at the corresponding time. Two thirds of the subjects had reported values in such a manner as to obscure hyper- and hypoglycemia, leading to misleading clinical impressions about the fluctuation in metabolic control. Previous glycemic control, patterns of logbook recording, or visits to the clinic were not found to be predictive of the reliability of patient self-monitoring regimens.
对19名胰岛素依赖型糖尿病患者进行了评估，以确定毛细血管血糖监测中患者自行生成数据的整体可靠性。在12至14天的时间里，这些受试者使用的标准反射式血糖仪被内部装有能够按日期和时间存储所有血糖读数的存储芯片的血糖仪所取代。受试者并未意识到这一改动，并被指示继续按照以往的方式检测毛细血管血糖，并继续在日志中记录血糖仪读数。为了评估日志中记录的患者生成数据的可靠性，确定了检测结果的增加、删除和更改情况。日志中报告的平均血糖水平显著低于（p<0.0001）存储反射式血糖仪中记录的水平。日志与存储反射式血糖仪中的差异范围为0至109mg/dl。四分之三的受试者报告的血糖平均值低于实际值。漏报或遗漏存储反射式血糖仪读数的平均比例为10%，而虚报或添加虚假值的平均比例为40%。日志条目中平均有26%与相应时间测定的存储反射式血糖仪值不一致。三分之二的受试者报告的值掩盖了高血糖和低血糖情况，导致对代谢控制波动产生误导性的临床印象。未发现先前的血糖控制情况、日志记录模式或门诊就诊情况可预测患者自我监测方案的可靠性。
