diabetes
Conditions
Interventions
experiment group:Insulin was injected subcutaneously with the experimental needle-free injection system
control group:Control needle - free injection system was used with hypodermic injection of insulin
Sponsors
Jiangxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with diabetes requiring subcutaneous insulin injection. 2. Ages 18 to 75, regardless of gender. 3. 18 kg/m^2 = 8 weeks at the time of screening. 6. Voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Injection site infection. 2. Patients with severe bleeding or severe disorders of bleeding or coagulation (International Normalized Ratio (INR) > 2.5) or platelets below 50*10^9/L. 3. Patients with severe anemia and hemoglobin disorders (hemoglobin less than 60 g/L). 4. Patients with severe liver and kidney function abnormalities (for laboratory test indicators exceeding two times the upper limit of the reference range). 5. Patients who are pregnant, lactating and have recent childbirth plans. 6. Patients with severe cardiovascular diseases (unstable myocardial infarction, cerebral infarction, unstable angina pectoris, severe arrhythmias). 7. Patients with malignant tumors. 8. Patients without the ability to express themselves verbally; patients with impaired consciousness. 9. Patients with mental illness or medical history. 10. Patients who, in the opinion of the investigator, are not suitable to participate in this clinical trial. 11. Patients who participated in other clinical trials within the month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of serum insulin concentration within 3 hours after breakfast; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the blood glucose concentration curve 3 hours after breakfast;Compliance of needle-free injection systems; | — |
Countries
China
Contacts
Public ContactJiangdong Liu
Jiangxi Provincial People's Hospital
Outcome results
None listed