Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1. Basic parameters: 14 years — 50 years · 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 evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is: 1. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency; 2. To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort. This study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who "progressed to insulin deficiency" and those who "progressed to severe insulin deficiency". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.
Primary outcome measures
- C-peptide [Time frame: "baseline"、"third year"]
Secondary outcome measures (3)
- Fasting and 2 - hour blood glucose [Time frame: "baseline"、"third year"]
- Glycosylated hemoglobin [Time frame: "baseline"、"third year"]
- Whether insulin treatment is needed [Time frame: "baseline"、"third year"]
Eligibility criteria
Inclusion criteria
- Gender is not restricted.
- Age ranges from 14 to 50 years old.
- Diagnosis of diabetes within < 1 year:
- If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol/L (200 mg/dL), or② Fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL), or③ Plasma glucose 2 hours after OGTT/post - meal ≥ 11.1 mmol/L (200 mg/dL), or④ HbA1c ≥ 6.5%.
- If there are no diabetes symptoms, another test on a different day is required for diagnosis.
- Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.
Exclusion criteria
- Peak C-peptide < 200 pmol/L;
- Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;
- Those who have been under long-term treatment with hormones or immunosuppressants;
- Pregnant or lactating women;
- Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;
- Those with an expected survival time of less than 3 years;
- Those with mental disorders or unable to cooperate with the investigation for other reasons;
- Acute phase of diabetic ketoacidosis;
- Stress conditions such as severe infection, fever, trauma, and major surgery;
- Patients lacking major clinical information;
- Those considered by the researcher as unfit to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South Universi — Changsha
Identifiers
NCT: NCT07621445 · 2025 T1DGRS LYF20250124