Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06606509

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Type1 Diabetes Mellitus

Sex eligibility

All sexes

Study type

Observational

Primary location

Anqing Municipal Hospital, Anqing, Anhui, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Glucose Monitoring System (GX-01S)

Device

Patients with Type 1 Diabetes Mellitus (T1DM) will receive Continuous Glucose Monitoring System (GX-01S) for seven days.

Primary outcomes

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

    Time frame: 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.

  2. Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes

    Time frame: 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

  3. Potential beneficiary groups of continuous glucose monitoring

    Time frame: 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 outcomes

  1. Current treatment status of Chinese patients with type 1 diabetes

    Time frame: 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.

  2. Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes

    Time frame: 3 years

    Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhua Ma, Doctor

CONTACT

[email protected]

18951670116 ext. +8618951670116

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

The Chinese Clinical Research Plan for the Survey of Treatment and Metabolic Status of Type 1 Diabetes Mellitus (T1DM).

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.