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临床试验/NCT05389839
NCT05389839招募中不适用

Application of Intelligent Insulin Dose Calculation Software in Patients With Insulin Therapy:A Randomized Controlled Intervention Trial

xiaolong zhao1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
182
试验地点
1
主要终点
Subjects in both groups targeted blood glucose range (TIR) time or ratio.

研究概览

简要总结

Insulin therapy is the mainstream glucose-lowering program for hospital glucose management. Intelligent insulin dose calculation software based on fingertip glucose monitoring is born in response to the situation. A new generation of continuous blood glucose monitoring technology compared with traditional monitoring technology provides more abundant blood sugar change information.The development of the continuous glucose monitoring technology espcially in blood sugar change trend arrow information, the intelligent insulin dose adjustment sequence based on WeChat program is developed. We plan to carry out a randomized controlled study on patients receiving insulin therapy, in which the insulin dose is adjusted according to the information of four blood glucose monitoring points (before meals and before bed), and randomly divided into two groups, one group is adjusted according to the experience of clinicians, the other group is adjusted according to Wechat program, and glucose monitoring is continued for 1 week. bBood glucose control index of TIR , and the incidence of hypoglycemia and hyperglycemia, hospitalization days and cost was observed. This study ihas great clinical value.

详细描述

The problems related to blood glucose in non-endocrine departments are becoming more and more serious.Glucose control level is closely related to the prognosis and cost of inpatients. Insulin therapy is the mainstream glucose-lowering program for hospital glucose management. Intelligent insulin dose calculation software based on fingertip glucose monitoring is born in response to the situation. A new generation of continuous blood glucose monitoring technology compared with traditional monitoring technology provides more abundant blood sugar change information.The development of the continuous glucose monitoring technology espcially in blood sugar change trend arrow information, the intelligent insulin dose adjustment sequence based on WeChat program is developed. We plan to carry out a randomized controlled study on patients receiving insulin therapy, in which the insulin dose is adjusted according to the information of four blood glucose monitoring points (before meals and before bed), and randomly divided into two groups, one group is adjusted according to the experience of clinicians, the other group is adjusted according to Wechat program, and glucose monitoring is continued for 1 week. bBood glucose control index of TIR , and the incidence of hypoglycemia and hyperglycemia, hospitalization days and cost was observed. This study ihas great clinical value.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-endocrine departments;
  • Currently using intensive insulin therapy with basic meals;
  • Belong to type 1 or Type 2 diabetes
  • Hospitalized patients
  • Regular meals

排除标准

  • Unwilling to participate or unable to cooperate.
  • Myocardial infarction or cardiovascular and cerebrovascular events in the last 3 months;
  • Glomerular filtration rate < 45 ml/min / 1.73 m2;
  • Other serious concomitant diseases;
  • Liver function transaminase is 2 times higher than the upper limit of normal range;
  • Use of oral hypoglycemic drugs other than metformin
  • Asymptomatic hypoglycemia

结局指标

主要结局

Subjects in both groups targeted blood glucose range (TIR) time or ratio.

时间窗: one week

Subjects in both groups targeted blood glucose range (TIR) time or ratio.

次要结局

  • insulin dose(one week)
  • below target blood glucose range (TBR) for time or Proportion(one week)
  • Mean blood glucose(one week)
  • above target blood glucose range (TAR) for time or ratio,(one week)
  • hospitalization cost(one week)
  • hospitalization length of stay(one week)

研究者

发起方
xiaolong zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xiaolong zhao

director

Huashan Hospital

研究点 (1)

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