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临床试验/NCT06117449
NCT06117449尚未招募不适用

Effectiveness and Satisfaction of Insulin Therapy in Type 2 Diabetic Patients (Real Life Study)

Assiut University0 个研究点目标入组 100 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
blood glucose level

研究概览

简要总结

Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both.

A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity.

Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with type 2 diabetes mellitus aged ≥18 years.
  • Patients going on insulin therapy versus patients going on oral antidiabetic drugs.
  • patients included if they met the following
  • previous diagnosis of diabetes mellitus or on medical therapy of DM.
  • no prescription fills for a basal insulin containing product in the 1-year pre index date period; and no prescription fills for bolus insulin or mixed insulin products on index date or in the 1-year pre-index date periods.

排除标准

  • Patients had type 1 diabetes mellitus.
  • Pregnant patients.
  • Incapable of completing the study questionnaires.
  • were pregnant at any time during the pre-or post-index periods; or
  • were diagnosed with any other type of diabetes during the study period, including, gestational diabetes , secondary diabetes , or other abnormal glu-cose conditions .
  • Patients who were con-comitantly participating in another trial or receiving insulin treatment for reasons other than T2DM.

结局指标

主要结局

blood glucose level

时间窗: baseline

comparison of blood glucose level on patients who going on insulin therapy with patient going on oral antidiabetic

HbA1C level

时间窗: baseline

comparison of HbA1C level on patients who going on insulin therapy with patient going on oral antidiabetic

次要结局

未报告次要终点

研究者

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

Esraa Ashraf Mohamed Hussein

doctor

Assiut University

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