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一项关于胰岛素治疗的I型和II型糖尿病患者低血糖情况的国际调查:非干预性IO HAT研究的土耳其队列

An international survey on hypoglycemia among insulin-treated type I and type II diabetes patients: Turkey cohort of the non-interventional IO HAT study.

作者信息

Emral Rıfat, Tetiker Tamer, Sahin Ibrahim, Sari Ramazan, Kaya Ahmet, Yetkin İlhan, Cil Sefika Uslu, Tütüncü Neslihan Başcıl

机构信息

Department of Endocrinology and Metabolic Diseases, Ankara University, Faculty of Medicine, İbn-i Sina Hospital, Academic Region M1/09, Samanpazarı, 06100, Ankara, Turkey.

Faculty of Medicine, Department of Endocrinology and Metabolic Diseases, Çukurova University, Adana, Turkey.

出版信息

BMC Endocr Disord. 2018 Feb 13;18(1):9. doi: 10.1186/s12902-018-0238-2.

DOI:10.1186/s12902-018-0238-2
PMID:29433560
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5809967/
Abstract

BACKGROUND

Limited real-world data are currently available on hypoglycemia in diabetes patients. The International Operations Hypoglycemia Assessment Tool (IO HAT) study was designed to estimate hypoglycemia in insulin-treated type I (T1DM) and type II (T2DM) diabetes mellitus patients from 9 countries. The data from Turkey cohort are presented here.

METHODS

A non-interventional study to determine the hypoglycemia incidence, retrospectively and prospectively, in Turkish T1DM and T2DM patients using a 2-part self-assessment questionnaire.

RESULTS

Overall, 2348 patients were enrolled in the Turkey cohort (T1DM = 306 patients, T2DM = 2042 patients). In T1DM patients, 96.8% patients reported hypoglycemic events (Incidence rate [IR]: 68.6 events per patient-year [ppy]), prospectively, while 74.0% patients reported hypoglycemic events (IR: 51.7 events ppy), retrospectively. In T2DM patients, 95.9% patients (IR: 28.3 events ppy) reported hypoglycemic events, prospectively, while 53.6% patients (IR: 23.0 events ppy) reported hypoglycemic events, retrospectively. Nearly all patients reported hypoglycemia during the prospective period.

CONCLUSIONS

This is a first patient-reported dataset on hypoglycemia in Turkish, insulin-treated diabetes patients. A high incidence of patient-reported hypoglycemia confirms that hypoglycemia remains under-estimated. Hypoglycemia increased healthcare utilization impacting patients' quality of life. Hypoglycemia remains a common side effect with insulin-treatment and strategies to optimize therapy and reduce hypoglycemia occurrence in diabetes patients are required.

TRIAL REGISTRATION

Clinicaltrials.gov, NCT02306681 (Date of registration: 12 Nov 2014; retrospectively registered).

摘要

背景

目前关于糖尿病患者低血糖的真实世界数据有限。国际行动低血糖评估工具(IO HAT)研究旨在估计来自9个国家的接受胰岛素治疗的I型(T1DM)和II型(T2DM)糖尿病患者的低血糖情况。本文展示了土耳其队列的数据。

方法

一项非干预性研究,通过两部分的自我评估问卷,回顾性和前瞻性地确定土耳其T1DM和T2DM患者的低血糖发生率。

结果

总体而言,2348名患者纳入了土耳其队列(T1DM = 306例患者,T2DM = 2042例患者)。前瞻性研究中,T1DM患者有96.8%报告了低血糖事件(发生率[IR]:68.6次事件/患者年[ppy]),回顾性研究中则有74.0%的患者报告了低血糖事件(IR:51.7次事件/ppy)。前瞻性研究中,T2DM患者有95.9%(IR:28.3次事件/ppy)报告了低血糖事件,回顾性研究中则有53.6%的患者(IR:23.0次事件/ppy)报告了低血糖事件。几乎所有患者在前瞻性研究期间都报告了低血糖。

结论

这是首个关于土耳其接受胰岛素治疗的糖尿病患者低血糖情况的患者报告数据集。患者报告的低血糖高发生率证实了低血糖仍被低估。低血糖增加了医疗保健利用率,影响患者生活质量。低血糖仍然是胰岛素治疗的常见副作用,需要采取策略优化治疗并减少糖尿病患者低血糖的发生。

试验注册

Clinicaltrials.gov,NCT02306681(注册日期:2014年11月12日;回顾性注册)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/6e468afca0aa/12902_2018_238_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/0ee6b37ecce1/12902_2018_238_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/453e962695b3/12902_2018_238_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/f1d337ca9f3a/12902_2018_238_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/8b7b41a49215/12902_2018_238_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/4f55d9388b36/12902_2018_238_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/58dbff9b052e/12902_2018_238_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/6e468afca0aa/12902_2018_238_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/0ee6b37ecce1/12902_2018_238_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/453e962695b3/12902_2018_238_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/331e9f0a604e/12902_2018_238_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/f1d337ca9f3a/12902_2018_238_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/8b7b41a49215/12902_2018_238_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/4f55d9388b36/12902_2018_238_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/58dbff9b052e/12902_2018_238_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec3d/5809967/6e468afca0aa/12902_2018_238_Fig8_HTML.jpg

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