Physician-Nurse Intervention With An Intelligent System for Hypoglycemia in Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,255
- 试验地点
- 1
- 主要终点
- Incidence of Hypoglycemia
研究概览
简要总结
The goal of this clinical study is to learn whether a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System can reduce hypoglycemia and improve glycemic control in hospitalized adults with type 2 diabetes receiving intensive insulin pump therapy. The study also aims to understand how risk-stratified management influences the time needed to reach glycemic targets.
The main questions this study aims to answer are:
- Does the physician-nurse collaborative intervention reduce the incidence of hypoglycemia, particularly level 2 and symptomatic hypoglycemia?
- Does this intervention help patients reach their glycemic targets sooner during intensive insulin pump therapy?
- What differences in outcomes are observed between patients classified as high-risk and low-risk by the Intelligent Hypoglycemia Risk Early-Warning System?
Participants will:
- Receive either standard insulin pump therapy alone or insulin pump therapy combined with the physician-nurse collaborative intervention
- Undergo hypoglycemia risk assessment using the Intelligent Early-Warning System
- Receive individualized insulin dose adjustments, intensified glucose monitoring, and tailored hypoglycemia education based on their risk category
- Be monitored for hypoglycemic events and time to achieve glycemic targets during hospitalization This study will compare the collaborative intervention with standard care to evaluate its effectiveness in preventing hypoglycemia and accelerating glycemic stabilization among hospitalized patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus.
- •Age 18 years or older.
- •Hospitalized for 3 days or longer.
- •Receiving continuous subcutaneous insulin infusion (CSII) therapy during hospitalization.
排除标准
- •Acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state).
- •Severe cardiovascular or cerebrovascular disease, hepatic dysfunction, or renal dysfunction.
- •Malignant tumors.
- •Severe cognitive impairment or psychiatric disorders that prevent cooperation.
- •Premature discontinuation of CSII therapy due to non-glycemic reasons.
结局指标
主要结局
Incidence of Hypoglycemia
时间窗: From the date of randomization until hospital discharge, assessed up to 14 days.
The proportion of participants experiencing hypoglycemia, defined as blood glucose \< 3.9 mmol/L. Hypoglycemia will be further classified into level 1, level 2, level 3, symptomatic, and asymptomatic categories based on international clinical criteria.
次要结局
- Time to Glycemic Target(From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.)
研究者
Xiling Hu
Chief Nurse
Third Affiliated Hospital, Sun Yat-Sen University