China Monogenic Diabetes Registry (CMDR)

March 19, 2026 updated by: Hua Shu, Tianjin Medical University General Hospital

This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to:

Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution

Participants will:

  • Enroll in the monogenic diabetes registry via mobile application or web-based platform
  • Undergo molecular genetic testing to establish a definitive diagnosis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will include the subjects of a series of studies on monogenic diabetes conducted by our team, including neonatal diabetes, maturity-onset diabetes of the young, maternally inherited diabetes and deafness, and other monogenic diabetes caused by different causative genes, and establish a large sample database and specimen bank through follow-up and omics analysis.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diabetes patients who completed gene test and necessary further tests and voluntary to be followed up will be included.

Description

Inclusion Criteria:

  1. Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age
  2. Body mass index (BMI) at diagnosis 28 kg/m²
  3. Negative glutamic acid decarboxylase antibody (GAD-Ab)

Exclusion Criteria:

  1. Secondary diabetes
  2. Active malignancy or history of malignant tumor within the past 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Monogenic Diabetes
Other: No Interventions
No Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screened and confirmed monogenic diabetes
Time Frame: 6 months
Screened and confirmed through genetic testing according to established diagnostic criteria for monogenic forms of diabetes (including MODY, neonatal diabetes, and other monogenic subtypes)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2021

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2022-YX-164-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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