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Recruiting NCT06746610

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

Trial Parameters

Condition Monogenic Diabetes
Sponsor Tianjin Medical University General Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2022-08-01
Completion 2027-07-31
Interventions
Genetic Screening for Monogenic Diabetes

Brief 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 Criteria

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.

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