Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes

NCT06746610•Tianjin Medical University General Hospital

Summary

The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are: * What are the genetic mutations causing MDM in China (genetic landscape)? * How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes? Participants will: * Register in the MDM platform via mobile app or internet-based software * Undergo genetic screening for MDM diagnosis * Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
•2. Body mass index (BMI) at diagnosis \< 28 kg/m2;
•3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion Criteria

•1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
•2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
•3. Patients with malignant tumors.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, China

Key Dates

Start Date

August 1, 2022

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2027

Last Updated

December 24, 2024

Enrollment

2,000

ESTIMATED participants

Conditions

Monogenic Diabetes

Interventions

Genetic Screening for Monogenic Diabetes

DIAGNOSTIC_TEST

Contacts

Ming Liu

CONTACT

+86 183 2201 7516 mingliu@tmu.edu.cn

National Registry of Rare Kidney Diseases

NCT06065852

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View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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