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NCT Number: NCT07492004

China Monogenic Diabetes Registry

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

Recruiting

Interested in participating?

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Key information

Conditions

Neonatal Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Maturity Onset Diabetes of the Young Metabolic Diseases Monogenic Diabetes Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Body mass index (BMI) at diagnosis 28 kg/m²
  • Negative glutamic acid decarboxylase antibody (GAD-Ab)

Exclusion criteria

  • Secondary diabetes
  • Active malignancy or history of malignant tumor within the past 5 years

Treatment and study plan

No interventions

Other

No Interventions

Primary outcomes

  1. 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)

Study contacts

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

Hua Shu

CONTACT

[email protected]

+86 15010106182

Ming Liu

CONTACT

[email protected]

+86 022-27813550

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Acronym: CMDR

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

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.

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