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临床试验/NCT02068300
NCT02068300已完成不适用

1,5-Anhydro-D-Glucitol Can Reflect Hypoglycemia in Patients With Well Controlled Type 2 Diabetes

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score

研究概览

简要总结

The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol (1,5-AG) as a novel surrogate marker of hypoglycemia

详细描述

We enrolled well controlled diabetes patients who had hypoglycemic event at least one time more. All patients assess the risk of severe hypoglycemia and hypoglycemic unawareness using hypoglycemic awareness questionnaires (HYPO score). The patients who are treated with insulin agent were inserted sensor of continuous glucose monitoring systems under the skin during three days. We were analysed the correlation between 1,5-anhydro-D-glucitol and HYPO score.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • patients attending outpatients of department of endocrinology and metabolism, seoul national university hospital .(HbA1C <8%)
  • The patients who treated with insulin or sulfonylureas at least 3month period
  • In case fo sulfonylurea user, HbA1c was restricted under 8%
  • The patients who had hypoglycemic event at least 3 months
  • who has can be survey questionnaire
  • who can insert continuous glucose monitoring system

排除标准

  • renal dysfunction patients
  • hepatic dysfunction patients
  • who has any kind of diseases, operations, medical treatments that can affect glucose levels

结局指标

主要结局

The correlation between 1,5-anhydro-D-glucitol and Modified Hypoglycemic score

时间窗: within the least 3 months

Modified hypoglycemic score was calculated by modified Clarke et al. questionnaire.

次要结局

  • The relation between glycemic variability indices such as MAGE of continuous glucose monitoring system and 1,5-AG in insulin using patients.(within at least 3months)
  • The correlation between hypoglycemic percent of Continuous glucose monitoring system and modified hypoglycemic score in insulin using patients.(within at leat 3months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hye Seung Jung

associate professor

Seoul National University Hospital

研究点 (1)

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