This is a multicenter observational study that examines patients with fulminant type 1 diabetes (a very rapidly developing form of type 1 diabetes) in China and assesses genetic markers such as HLA. Patients meeting the defined diagnostic criteria, together with healthy volunteers for comparison, are included. It is a non-interventional (observational) study and is currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
patients with fulminant 1 diabetes Inclusion Criteria: 1\) diabetic ketosis or ketoacidosis occurred soon after the onset of hyperglycemic symptoms; 2) patient presented with plasma glucose ≥16.0 mmol/L and HbA1c \<8.7% at the first visit; and 3) patient had urinary C-peptide excretion \<10 µg/day,fasting serum C-peptide level \<0.10 nmol/L, or postprandial serum C-peptide \<0.17 nmol/L at onset Exclusion Criteria: Case reports of previously diagnosed with diabetes were excluded. Healthy Volunteers Inclusion Criteria: * Normal control: The inclusion criteria are as follows: (1) Oral glucose tolerance test (OGTT): fasting blood glucose (FPG) \<5.6 mmol/L and postprandial 2 h blood glucose (PPG) \<7.8 mmol/L. The participants voluntarily signed the informed consent and extracted 3ml of peripheral blood for DNA extraction. Exclusion Criteria: * The exclusion criteria were as follows: (1) with heart, brain, liver, kidney or other chronic diseases; (2) with other types of autoimmune diseases; (3) with malignant tumors; (4) with a family history of diabetes.