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临床试验/NCT04833413
NCT04833413招募中不适用

Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes

Shanghai Zhongshan Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年4月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
2
主要终点
Change in HbA1c

研究概览

简要总结

Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment.

详细描述

Selecting initial insulin intensive therapy during the period of hospitalization in patients with type 2 diabetes, collect the basic information and biochemical information collection, including gender, age, duration of diabetes, intensive glucose-lowering treatment plan before treatment, diabetes complications, merger disease, smoking, drinking, height, weight, blood pressure, fasting glucose, glycosylated hemoglobin and glycosylated serum protein, insulin, c-peptide, liver and kidney function, blood lipid, blood routine, hypoglycemia is happening almost 1 month. Follow-up was conducted in January, March and June. Endocrinologists decide whether to continue the original hypoglycemic regimen or adjust it according to the glycemic control goals, islet β-cell function, diabetes complications, complications, hypoglycemia and other combination drugs, as well as patients' treatment willingness and compliance. To compare the timing of conversion of treatment regimens, the proportion of conversion to each regimen and the situation of reaching the standard, and to further analyze and compare the characteristics of people who switched to different regimens, in order to establish the basis for the selection of adjustment regimens after insulin treatment.

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;
  • Patients who started intensive insulin therapy during hospitalization
  • Age ≥18 years old

排除标准

  • Type 1 diabetes, special type diabetes
  • Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity)
  • Severe infection
  • pregnancy or planned pregnancy
  • Participating in other clinical studies or trials

研究组 & 干预措施

Continue intensive treatment group

Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge

干预措施: Continuous intensive insulin therapy (Drug)

Premixed insulin treatment group

Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge

干预措施: Continuous intensive insulin therapy (Drug)

Basic insulin treatment group

Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge

干预措施: Continuous intensive insulin therapy (Drug)

结局指标

主要结局

Change in HbA1c

时间窗: 1,3,6 months

HbA1c in different conversion regimens

次要结局

  • Impact on body weight(1,3,6 months)
  • The average blood glucose(1,3,6 months)
  • Fasting blood glucose(1,3,6 months)
  • Incidence of hypoglycemia(1,3,6 months)
  • Postprandial blood glucose(1,3,6 months)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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