Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Genetic Screening for Monogenic Diabetes.
- Who it may be relevant to
- Registry conditions: Monogenic Diabetes. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Interventions
- Diagnostic test Genetic Screening for Monogenic Diabetes
This intervention involves genetic testing for monogenic diabetes (MDM) in recruited participants. The testing includes either a panel test specifically targeting genes associated with monogenic diabetes or whole exome sequencing (WES) to comprehensively identify genetic variants linked to MDM. Precise diagnosis and treatmen： 1. The clinical trial of individualized treatment was carried out for the individuals with diabetes with HNF1A mutation. 2. The research team will closely follow up indiv
Primary outcome measures
- Genetic landscape of monogenic diabetes mellitus in China [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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;
- Body mass index (BMI) at diagnosis < 28 kg/m2;
- Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;
Exclusion criteria
- Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
- Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
- Patients with malignant tumors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT06746610 · IRB2022-YX-164-01