The Chinese Clinical Research Plan for the Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 101
- 主要终点
- Current status of blood sugar control in Chinese patients with type 1 diabetes
研究概览
简要总结
This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). By reviewing clinical data, physical examinations, questionnaires, continuous glucose monitoring, and subcutaneous fat ultrasound, we aim to understand the current status of treatment and metabolism in Chinese T1DM patients and analyze the potential factors that may affect their blood sugar control and metabolic indicators. A cost-effectiveness analysis will be conducted on Chinese T1DM patients using continuous glucose monitoring systems to identify the groups that benefit most from these systems.
详细描述
This study is a multicenter cross-sectional research project, planning to enroll 1000 patients with Type 1 Diabetes Mellitus (T1DM). This study will collect multicenter data on T1DM patients, including sociodemographic information, anthropometric measurements, glycemic indices (glycated hemoglobin, fasting blood glucose, postprandial blood glucose), acute and chronic complications, other important metabolic indicators (blood lipids, vitamin D), insulin treatment methods, blood glucose monitoring status, diabetes education, diet and exercise, social and psychological support, and extra-pancreatic autoimmune diseases. The aims are: 1. To understand the current state of treatment and glycemic metabolism in Chinese T1DM patients and to analyze the potential factors that may affect their glycemic indices. 2. To understand the current status of continuous glucose monitoring (CGM) usage in Chinese T1DM patients and to analyze the impact of CGM on blood glucose control, acute and chronic complications, and quality of life in T1DM patients. 3. Through cost-benefit analysis, to identify potential beneficiary groups for CGM, providing objective evidence for the demand of this technology to healthcare professionals and diabetes patients; to provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate and be able to sign informed consent
- •Patients with type 1 diabetes
- •At least one of the following three clinical characteristics must be met: The disease presents initially with diabetic ketoacidosis (DKA) or ketonuria; The presence of islet-related autoantibodies, such as islet cell antibodies, tyrosine phosphatase antibodies, or glutamic acid decarboxylase (GAD) antibodies, is detected positively; Both fasting and postprandial C-peptide levels are ≤0.6 ng/mL.
排除标准
- •Other types of diabetes.
- •Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.
结局指标
主要结局
Current status of blood sugar control in Chinese patients with type 1 diabetes
时间窗: 3 years
Using continuous glucose monitoring systems to understand the current status of blood sugar control in Chinese patients with type 1 diabetes; analyzing the possible factors that may affect the glycometabolic indicators of Chinese patients with type 1 diabetes.
Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes
时间窗: 3 years
Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes, and analyze its impact on blood sugar control, acute and chronic complications, and quality of life for patients with type 1 diabetes
Potential beneficiary groups of continuous glucose monitoring
时间窗: 3 years
Through cost-effectiveness analysis, identify the potential beneficiary groups of continuous glucose monitoring to provide objective evidence for the demand for this technology by healthcare professionals and diabetes patients; provide effective information for the formulation of medical insurance reimbursement policies for continuous glucose monitoring.
次要结局
- Current treatment status of Chinese patients with type 1 diabetes(3 years)
- Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes(3 years)