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

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

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.

Inclusion Criteria:

• Gender is not restricted.

• Age ranges from 14 to 50 years old.

• Diagnosis of diabetes within < 1 year:

  1. 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%.
  2. 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.