The Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

Not yet recruiting

• Conditions: Type1 Diabetes Mellitus

• Registration Number: NCT06606509
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2024-11-07
• Primary Completion: 2026-10-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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.

Exclusion Criteria

• Other types of diabetes.
• Patients who cannot cooperate with the use of continuous glucose monitoring, clinical data collection, and questionnaire completion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current status of blood sugar control in Chinese patients with type 1 diabetes	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Current treatment status of Chinese patients with type 1 diabetes	3 years	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	3 years	Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes

Trial Locations

Locations (101)

Anqing Municipal Hospital; 🇨🇳 Anqing, Anhui, China

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, Anhui, China

Hefei First People's Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of USTC,; 🇨🇳 Hefei, Anhui, China

The second People's Hospital,wuhu; 🇨🇳 Wuhu, Anhui, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shenzhen Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Shougang Hospital; 🇨🇳 Beijing, Beijing, China

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