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临床试验/NCT02306681
NCT02306681已完成不适用

An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 7,315 人开始时间: 2014年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,315
试验地点
1
主要终点
The percentage of patients who experience at least 1 hypoglycaemic episode

研究概览

简要总结

This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Informed consent obtained before any trial-related activities
  • Patient with T1DM or T2DM treated with insulin for more than 12 months
  • Male or female patient at least 18 years of age at the time of inclusion in the study

排除标准

  • Previous participation in this study
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
  • Non-ambulatory patients
  • Simultaneous participation in any other clinical study with an investigational product

结局指标

主要结局

The percentage of patients who experience at least 1 hypoglycaemic episode

时间窗: During the 4-week prospective observational period

次要结局

  • Patient reported fear of hypoglycaemia(Over one day)
  • Incidence of documented symptomatic hypoglycaemic episodes(In the 4 weeks after the baseline visit (day 1))
  • Incidence of probable symptomatic hypoglycaemia(In the 4 weeks following the baseline visit (day 1))
  • Incidence of hypoglycaemic episodes requiring hospital admission(In the 6 months before and 4 weeks after the baseline (day 1))
  • Frequency of blood glucose monitoring(Over 1 day)
  • Patient reported recovery times(One day)
  • Proportion of patients increasing calorie intake(Over one day)
  • Proportion of patients avoiding physical exercise(Over one day)
  • Proportion of patients reducing or skipping insulin dose(Over one day)
  • Incidence of severe hypoglycaemic episodes(In the 6 months before and 4 weeks after the baseline (day 1))
  • Proportion of patients consulting a doctor(Over one day)
  • Incidence of any hypoglycaemic episodes(In the 4 weeks before and 4 weeks after the baseline (day 1))
  • Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms(In the 4 weeks following the baseline visit (day 1))
  • Incidence of hypoglycaemic episodes(Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1))
  • Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes(Over one day)
  • Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes(Over one day)
  • DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores(Over last 4 weeks)
  • Incidence of non-severe hypoglycaemic episodes(In the 4 weeks before and 4 weeks after the baseline (day 1))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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