Khunti K, Alsifri S, Aronson R, Cigrovski Berković M, Enters-Weijnen C, Forsén T, Galstyan G, Geelhoed-Duijvestijn P, Goldfracht M, Gydesen H, Kapur R, Lalic N, Ludvik B, Moberg E, Pedersen-Bjergaard U, Ramachandran A
Diabetes Research Centre, University of Leicester, Leicester, UK.
Al Hada Military Hospital, Taif, Saudi Arabia.
Diabetes Obes Metab. 2016 Sep;18(9):907-15. doi: 10.1111/dom.12689. Epub 2016 Jun 20.
To determine the global extent of hypoglycaemia experienced by patients with diabetes using insulin, as there is a lack of data on the prevalence of hypoglycaemia in developed and developing countries.
This non-interventional, multicentre, 6-month retrospective and 4-week prospective study using self-assessment questionnaire and patient diaries included 27 585 patients, aged ≥18 years, with type 1 diabetes (T1D; n = 8022) or type 2 diabetes (T2D; n = 19 563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. The primary endpoint was the proportion of patients experiencing at least one hypoglycaemic event during the observational period.
During the prospective period, 83.0% of patients with T1D and 46.5% of patients with T2D reported hypoglycaemia. Rates of any, nocturnal and severe hypoglycaemia were 73.3 [95% confidence interval (CI) 72.6-74.0], 11.3 (95% CI 11.0-11.6) and 4.9 (95% CI 4.7-5.1) events/patient-year for T1D and 19.3 (95% CI 19.1-19.6), 3.7 (95% CI 3.6-3.8) and 2.5 events/patient-year (95% CI 2.4-2.5) for T2D, respectively. The highest rates of any hypoglycaemia were observed in Latin America for T1D and Russia for T2D. Glycated haemoglobin level was not a significant predictor of hypoglycaemia.
We report hypoglycaemia rates in a global population, including those in countries without previous data. Overall hypoglycaemia rates were high, with large variations between geographical regions. Further investigation into these differences may help to optimize therapy and reduce the risk of hypoglycaemia.
鉴于发达国家和发展中国家缺乏低血糖患病率的数据,确定使用胰岛素的糖尿病患者低血糖在全球的发生情况。
这项非干预性、多中心、为期6个月的回顾性研究和为期4周的前瞻性研究,使用自我评估问卷和患者日记,纳入了全球24个国家2004个研究点的27585例年龄≥18岁、1型糖尿病(T1D;n = 8022)或2型糖尿病(T2D;n = 19563)且使用胰岛素治疗超过12个月的患者。主要终点是观察期内发生至少一次低血糖事件的患者比例。
在前瞻性研究期间,83.0%的T1D患者和46.5%的T2D患者报告有低血糖。T1D患者任何低血糖、夜间低血糖和严重低血糖的发生率分别为73.3[95%置信区间(CI)72.6 - 74.0]、11.3(95%CI 11.0 - 11.6)和4.9(95%CI 4.7 - 5.1)次/患者年,T2D患者分别为19.3(95%CI 19.1 - 19.6)、3.7(95%CI 3.6 - 3.8)和2.5次/患者年(95%CI 2.4 - 2.5)。T1D患者任何低血糖发生率最高的地区是拉丁美洲,T2D患者是俄罗斯。糖化血红蛋白水平不是低血糖的显著预测因素。
我们报告了全球人群的低血糖发生率,包括以前没有数据的国家。总体低血糖发生率很高,地理区域之间存在很大差异。对这些差异进行进一步研究可能有助于优化治疗并降低低血糖风险。