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

Summary

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.

Eligibility

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.

Conditions3

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