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印度尼西亚胰岛素治疗的1型和2型糖尿病患者回顾性和前瞻性阶段糖尿病管理、控制及并发症评估的IO HAT研究队列

Indonesia Cohort of IO HAT Study to Evaluate Diabetes Management, Control, and Complications in Retrospective and Prospective Periods Among Insulin-Treated Patients with Type 1 and Type 2 Diabetes.

作者信息

Rudijanto Achmad, Saraswati Made R, Yunir Em, Kumala Poppy, Puteri Happy Hs, Mandang Veny Vv

机构信息

Department of Internal Medicine, Faculty of Medicine, Brawijaya University, Malang, Indonesia.

出版信息

Acta Med Indones. 2018 Jan;50(1):26-37.

Abstract

BACKGROUND

hypoglycemia is a major adverse event of insulin therapy for diabetes mellitus patients. The study was conducted to evaluate the incidence of hypoglycemia among insulin treated patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the Indonesian cohort.

METHODS

this Indonesian cohort study consisted of retrospective and prospective evaluation of hypoglycemic episodes, using International Operations Hypoglycemia Assessment Tool (IO HAT) in 374 patients with diabetes (T1DM; n=17 or T2DM; n=357). The patients of ≥18 years of age and treated with insulin for >12 months were selected for this study (ClinicalTrials.gov number: NCT02306681).

RESULTS

a total of 374 patients were enrolled in this study and completed SAQ1. All patients with T1DM (17 [100%]), and 347 (97.2%) patients with T2DM completed SAQ2. Almost all the patients in the 4-week prospective period reported at least one hypoglycemic event (T1DM 100%, T2DM 99.4%) and the incidence rate of any hypoglycemia was 67.5 events per patient-year (PPY) and 25.7 events PPY for T1DM and T2DM patients, respectively. Among patients with T1DM and T2DM, 5.9% and 36.4%, respectively, did not know what hypoglycemia was at baseline, also high proportion of patients had impaired hypoglycemic awareness in the study (82.4% and 62.7%, respectively).

CONCLUSION

overall, high proportion of patients reported hypoglycemic events in the prospective period indicating under reporting during the retrospective period due to recall bias. Therefore, there is a need for patient education program to improve the awareness of hypoglycemia in diabetes patient in Indonesia.

摘要

背景

低血糖是糖尿病患者胰岛素治疗的主要不良事件。本研究旨在评估印度尼西亚队列中1型糖尿病(T1DM)或2型糖尿病(T2DM)胰岛素治疗患者的低血糖发生率。

方法

这项印度尼西亚队列研究包括对低血糖发作进行回顾性和前瞻性评估,使用国际低血糖评估工具(IO HAT)对374例糖尿病患者(T1DM;n = 17或T2DM;n = 357)进行评估。本研究选取年龄≥18岁且接受胰岛素治疗超过12个月的患者(ClinicalTrials.gov编号:NCT02306681)。

结果

本研究共纳入374例患者并完成SAQ1。所有T1DM患者(17例[100%])和347例(97.2%)T2DM患者完成了SAQ2。在4周的前瞻性观察期内,几乎所有患者均报告至少发生一次低血糖事件(T1DM为100%,T2DM为99.4%),T1DM和T2DM患者任何低血糖的发生率分别为每人每年67.5次事件和25.7次事件。在T1DM和T2DM患者中,分别有5.9%和36.4%的患者在基线时不知道什么是低血糖,研究中低血糖意识受损的患者比例也很高(分别为82.4%和62.7%)。

结论

总体而言,在前瞻性观察期内有很大比例的患者报告发生低血糖事件,这表明由于回忆偏倚,回顾期内存在报告不足的情况。因此,印度尼西亚需要开展患者教育项目,以提高糖尿病患者对低血糖的认识。

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