Hypoglycemia in type 2 diabetes mellitus (T2DM) is still unsolved issue. The aim of this study was to investigate hypoglycemia in T2DM in participants treated with oral antihyperglycemic agents using different glucose cut-off values and to explore influence of different therapies. This multi-center prospective observational study included participant with T2DM from primary care offices across Croatia treated with antihyperglycemic agents who were monitored using professional continuous glucose monitoring (CGM) device (iPro™2). Hypoglycemia was defined as at least 1% of the monitored period spent in the hypoglycemic range and/or area under the curve of glycemia registered ever under the defined cut-off value. The higher upper limit of blood glucose cut-off value was 3.9 mmol/L (70 mg/dL) and the lower one 3.0 mmol/L (54 mg/dL). Study included 94 participants. Median hemoglobin A1C levels, age, T2DM duration, body mass index, and CGM use duration were 7 (5.8–11.5) %, 65 (40–86) years, 7 (1–36) years, 30.4 (21.3–41.5) kg/m2 and 6 (1–7) days, respectively. Fifty participants were treated with sulfonylurea, primarily gliclazide (84%). The percentage of participant with hypoglycemia based on the higher cut-off value was 42.6% vs. 16% based on the higher cut-off value. The percentage of participant with nocturnal hypoglycemia (23 PM to 06 AM) was significantly lower among participant with hypoglycemia based on the higher cut-off value compared to lower one (7.8% vs. 22.9%). Sulfonylurea treatment did not influence the occurrence of hypoglycemia. Analysis of the data from participants having hypoglycemia based on the lower cut-off value pointed to other possible risk factors for hypoglycemia like prolonged overnight fasting, physical activity, alcohol consumption, and concomitant therapy with angiotensin-converting enzyme inhibitors. In participant with T2DM treated with oral antihyperglycemic agents hypoglycemia based on the blood glucose cut-off value of 3.9 mmol/L was more prevalent, but with less nocturnal hypoglycemia. Sulfonylurea therapy was not risk factor for hypoglycemia regardless of cut-off value. In participants having hypoglycemia based on the blood glucose cut-off value of 3.0 mmol/L some other possible factors were identified related to concomitant therapy, nutrition and daily habits. ClinicalTrials.gov Identifier: NCT03253237.

中文翻译：

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通过连续血糖监测发现口服降糖药治疗的2型糖尿病患者的低血糖：克罗地亚的一项多中心前瞻性观察研究

2型糖尿病（T2DM）中的低血糖症仍未解决。这项研究的目的是调查使用不同的血糖临界值口服抗降糖药的参与者的T2DM中的低血糖，并探讨不同疗法的影响。这项多中心前瞻性观察性研究包括来自克罗地亚各地初级保健机构的接受降糖药治疗的T2DM患者，他们使用专业连续血糖监测（CGM）设备（iPro™2）进行了监测。低血糖症定义为在定义的临界值以下记录的低血糖范围和/或血糖曲线下面积所花费的监测时间的至少1％。血糖截止值的较高上限为3.9 mmol / L（70 mg / dL），较低的为3.0 mmol / L（54 mg / dL）。研究包括94名参与者。血红蛋白A1C水平，年龄，T2DM持续时间，体重指数和CGM使用持续时间分别为7（5.8-11.5）％，65（40-86）岁，7（1-36）岁，30.4（21.3-41.5）kg / m2和6（1-7）天。五十名参与者接受了磺脲类药物治疗，主要是格列齐特（84％）。基于较高的临界值的低血糖参与者百分比为42.6％，而基于较高的临界值的参与者为16％。由于较高的临界值与较低的临界值相比，夜间低血糖参与者（晚上23点至凌晨6点）的百分比显着较低（7.8％比22.9％）。磺脲类药物治疗不影响低血糖的发生。根据较低的临界值对低血糖参与者的数据进行分析后，发现其他可能导致低血糖的危险因素，例如过夜禁食时间延长，体力活动，饮酒以及使用血管紧张素转化酶抑制剂同时进行治疗。在接受口服降糖药治疗的T2DM患者中，以血糖截止值为3.9 mmol / L为基础的低血糖症更为普遍，但夜间低血糖症较少。不管临界值如何，磺酰脲疗法都不是低血糖的危险因素。在基于血糖截断值为3.0 mmol / L的低血糖参与者中，发现了其他一些可能的因素，这些因素与伴随疗法，营养和日常习惯有关。ClinicalTrials.gov标识符：NCT03253237。