About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Other types of diabetes.
Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.
Trial population
The study aims to recruit 1,000 patients with Type 1 Diabetes Mellitus (T1DM) from endocrinology departments across various centers between June 2024 and June 2025, both inpatient and outpatient.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Continuous Glucose Monitoring System (GX-01S)
DevicePatients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.
Treatment groups
Trial outcomes
Primary outcomes
Current status of blood sugar control in Chinese patients with type 1 diabetes
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
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
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.
Secondary outcomes
Current treatment status of Chinese patients with type 1 diabetes
Gain a multi-dimensional understanding of the current treatment status of Chinese patients with type 1 diabetes, including aspects such as blood glucose monitoring, education, drug treatment, nutrition, and social support.
Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes
Sponsors and contacts
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