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Not yet recruiting NCT06606509

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

— Observational Type1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Glucose Monitoring System (GX-01S).
Who it may be relevant to
Registry conditions: Type1 Diabetes Mellitus. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Current status of blood sugar control in Chinese patients with type 1 diabetes [Time frame: 3 years]
  • Understand the current status of the use of continuous glucose monitoring in China for type 1 diabetes [Time frame: 3 years]
  • Potential beneficiary groups of continuous glucose monitoring [Time frame: 3 years]
Secondary outcome measures (2)
  • Current treatment status of Chinese patients with type 1 diabetes [Time frame: 3 years]
  • Current status of extra-pancreatic autoimmune diseases in Chinese patients with type 1 diabetes [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 101 centers
  • Anqing Municipal Hospital — Anqing
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Hefei First People's Hospital — Hefei
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • The First Affiliated Hospital of USTC, — Hefei
  • The second People's Hospital,wuhu — Wuhu
  • China-Japan Friendship Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • … and 93 more centers

Identifiers

NCT: NCT06606509 · KY20240514-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗