Brož Jan, Janíčková Žďárská Denisa, Urbanová Jana, Piťhová Pavlína, Doničová Viera, Pálová Sabina, Pelechová Barbora, Smržová Anna, Kvapil Milan
Department of Internal Medicine, Second Faculty of Medicine, Charles University, V Úvalu 84, 150 00, Prague, Czech Republic.
Department of Internal Medicine, Third Faculty of Medicine and Faculty Hospital Královské Vinohrady, Charles University, Prague, Czech Republic.
Diabetes Ther. 2021 Jul;12(7):1799-1808. doi: 10.1007/s13300-021-01080-4. Epub 2021 May 24.
Despite the continuously growing number of therapeutic options for type 2 diabetes mellitus (T2DM) including insulins, a large percentage of patients fail to achieve HbA1c targets. Several real-world studies focused on patients with T2DM receiving insulin treatment in outpatient settings were conducted, but information about real-world in-hospital insulin management is lacking. The aim of this study was to describe the management of insulin therapy with a focus on basal-bolus and premixed insulin regimens in patients with T2DM under routine in-hospital medical practice in the Czech Republic.
This non-interventional prospective study was conducted from June 2014 to December 2017 in 22 centers in the Czech Republic under routine clinical practice conditions. Adult patients admitted to hospital with metabolically uncontrolled T2DM [HbA1c ≥ 60 mmol/mol; > 7.6% Diabetes Control and Complications Trial (DCCT)] and there treated with basal-bolus and premixed insulin regimens were documented during hospitalization.
Overall, 369 patients with T2DM (54.7% male, mean age 64.44 ± 13.84 years, BMI 31.10 ± 6.00 kg/m, duration of diabetes 8.11 ± 9.93 years, HbA1c 95.90 ± 24.38 mmol/mol, length of stay was 7.94 ± 4.53 days) were included. The percentage of glucose values under 10 mmol/l at time of randomization (the group with basal-bolus insulin regimen vs. the premix insulin regimen group) was 24.2% vs. 33.5% (p = 0.053), at time of first insulin dose adjustment it was 43.1% vs. 50.0% (p = 0.330), and 1 day before hospital discharge it was 61.7% vs. 61.4% (p = 0.107). A hypoglycemic event occurred in a total of 15 patients in the basal-bolus regimen group, and no hypoglycemic event occurred in the premixed insulin regimen group.
In-hospital insulin management regarding basal-bolus and premixed insulin regimens is safe and in concordance with current international recommendations.
尽管2型糖尿病(T2DM)的治疗选择不断增加,包括胰岛素,但仍有很大比例的患者未能达到糖化血红蛋白(HbA1c)目标。已经开展了多项针对门诊接受胰岛素治疗的T2DM患者的真实世界研究,但缺乏关于医院内胰岛素实际管理的信息。本研究的目的是描述在捷克共和国常规住院医疗实践中,T2DM患者胰岛素治疗的管理情况,重点关注基础-餐时胰岛素方案和预混胰岛素方案。
这项非干预性前瞻性研究于2014年6月至2017年12月在捷克共和国的22个中心,在常规临床实践条件下进行。记录住院期间收治的代谢控制不佳的T2DM成年患者[HbA1c≥60 mmol/mol;>7.6%糖尿病控制与并发症试验(DCCT)],以及接受基础-餐时胰岛素方案和预混胰岛素方案治疗的患者情况。
共纳入369例T2DM患者(男性占54.7%,平均年龄64.44±13.84岁,体重指数31.10±6.00 kg/m²,糖尿病病程8.11±9.93年,HbA1c 95.90±24.38 mmol/mol,住院时间7.94±4.53天)。随机分组时(基础-餐时胰岛素方案组与预混胰岛素方案组)血糖值低于10 mmol/l的百分比分别为24.2%和33.5%(p = 0.053),首次调整胰岛素剂量时分别为43.1%和50.0%(p = 0.330),出院前1天分别为61.7%和61.4%(p = 0.107)。基础-餐时胰岛素方案组共有15例患者发生低血糖事件,预混胰岛素方案组未发生低血糖事件。
关于基础-餐时胰岛素方案和预混胰岛素方案的院内胰岛素管理是安全的,并且符合当前国际推荐。