Diabetes
Conditions
Interventions
Initial insulin treatment group:Insulin
Routine treatment group:Guidelines recommended hypoglycemic treatment
Sponsors
PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of diabetes mellitus (diagnosis based on WHO[1999] diabetes diagnostic criteria); 2. Aged 18-40 years (inclusive); 3. The cluster classification was severe insulin deficiency diabetes(SIDD); 4. The duration of diabetes is less than 6 months; 5. Treatment with any hypoglycemic drug shall not exceed 1 month; 6. HbA1c >= 7%; 7. eGFR >= 45ml/min/1.73m^2.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or pregnancy plan in the next two years; 2. Breastfeeding or have a breastfeeding plan in the next two years; 3. Patients with the following medical history: (1) Diabetes is caused by pancreatic injury or secondary diabetes, such as Cushing syndrome or acromegaly; (2) Acute diabetic complications: a history of ketoacidosis or hyperosmolar non ketonic coma occurred in the past 6 months; (3) Systemic glucocorticoid (oral or intravenous) treatment for 7 consecutive days in the past 6 months; 4. Recurrent spontaneous diabetic ketosis or acute diabetes complications that have not been corrected; 5. Patients with significant clinical liver disease have any of the following characteristics: (1) Within four weeks before screening, abnormal liver function was measured twice continuously. Alanine aminotransferase and aspartate aminotransferase were three times of the upper limit of normal; (2) Excretory disorders (such as hyperbilirubinemia) and/or synthetic dysfunction, or decompensated liver diseases with other symptoms, such as coagulation disease, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal variceal bleeding; (3) Acute viral or active autoimmune, alcohol or other types of hepatitis; 6. Within 4 weeks before screening or examination, patients with moderate/severe renal injury or end-stage renal disease (creatinine > 194.5 umol/L or K + > 5.5 mmol/l); 7. New York Heart Association (NYHA) grade III or IV congestive heart failure with major cardiovascular history in the past 3 months is defined as: myocardial infarction, coronary angioplasty or bypass surgery, valve disease or repair, unstable angina pectoris, transient ischemic attack or cerebrovascular accident; 8. It has been diagnosed as malignant tumor or under treatment in the past 5 years; 9. History of organ transplantation or acquired immunodeficiency syndrome (AIDS); 10. History of alcohol or drug abuse in the past 12 months; 11. Potentially unreliable patients, and those who the researchers believe are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinopathy staging;Urinary albumin to creatinine ratio; | — |
Countries
China
Contacts
Public ContactMu Yiming
PLA General Hospital
Outcome results
None listed