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

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

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Overview

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

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.

Study details
    Monogenic Diabetes

NCT06746610

Tianjin Medical University General Hospital

5 September 2025

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