Pathan Faruque, Goh Su-Yen, Rudijanto Achmad, Gadekar Arvind, Jain Anand, Nicodemus Nemencio
Department of Endocrinology, BIRDEM Hospital, Dhaka, Bangladesh.
Singapore General Hospital, Singapore.
J ASEAN Fed Endocr Soc. 2018;33(1):28-36. doi: 10.15605/jafes.033.01.05. Epub 2018 Apr 4.
To provide real-world data on hypoglycaemia incidence in patients with type 1 (T1D) or type 2 diabetes (T2D) from the Southeast Asian cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study.
IO HAT was a non-interventional, multicentre, 6-month retrospective and 4-week prospective study of hypoglycaemic events among insulin-treated adults with T1D or T2D, including four countries in Southeast Asia (Singapore, Philippines, Indonesia, and Bangladesh). Data were collected using a two-part self-assessment questionnaire (SAQ1 for retrospective and SAQ2 for prospective). The primary endpoint was the percentage of patients experiencing at least one hypoglycaemic event during the 4-week prospective observational period (ClinicalTrials.gov Identifier: NCT02306681).
A total of 2594 patients completed SAQ1. Nearly all patients reported experiencing any hypoglycaemic event in the 4-week prospective period (T1D, 100%; T2D, 97.3%), with all patients reporting higher rates in the prospective versus retrospective period. Severe hypoglycaemia was also reported higher prospectively (57.2% and 76.9%) than retrospectively (33.9% and 12.2%) in both T1D and T2D, respectively. Nocturnal hypoglycaemia was reported higher retrospectively than prospectively.
Incidence of any and severe hypoglycaemia in the Southeast Asian cohort of IO HAT was higher prospectively versus retrospectively, suggesting hypoglycaemia has previously been under-reported in this region.
提供来自国际低血糖评估工具(IO HAT)研究东南亚队列中1型糖尿病(T1D)或2型糖尿病(T2D)患者低血糖发生率的真实世界数据。
IO HAT是一项针对接受胰岛素治疗的T1D或T2D成年患者低血糖事件的非干预性、多中心、为期6个月的回顾性研究及为期4周的前瞻性研究,研究对象包括东南亚四个国家(新加坡、菲律宾、印度尼西亚和孟加拉国)。数据通过两部分的自我评估问卷收集(回顾性研究用SAQ1,前瞻性研究用SAQ2)。主要终点是在为期4周的前瞻性观察期内发生至少一次低血糖事件的患者百分比(ClinicalTrials.gov标识符:NCT02306681)。
共有2594名患者完成了SAQ1。几乎所有患者均报告在为期4周的前瞻性观察期内发生过任何低血糖事件(T1D患者为100%;T2D患者为97.3%),所有患者报告的前瞻性观察期内的发生率均高于回顾性研究期。在T1D和T2D患者中,严重低血糖的前瞻性报告发生率也高于回顾性研究期(分别为57.2%和76.9%对比33.9%和12.2%)。夜间低血糖的回顾性报告发生率高于前瞻性报告发生率。
IO HAT东南亚队列中任何低血糖和严重低血糖的发生率前瞻性高于回顾性,表明该地区此前低血糖报告不足。