Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT03243903
Eligibility Criteria:
Inclusion Criteria:
1. have been diagnosed with type 2 diabetes; (A) have been treated with insulin (premixed or basal) subcutaneous injection therapy (without limitation or combined oral hypoglycemic agents); (B) the subjects with poor blood sugar control is taking oral hypoglycemic agents or living interventions need Initiating insulin therapy (see Appendix 1 for initiating treatment regimens);
2. adults aged 18-75 years, women of childbearing age need to take adequate contraceptive measures to reduce the pregnancy risk to the minimum;
3. injection of insulin and / or oral hypoglycemic agents ≥ 3 months before enroll the study, the insulin dose adjustment ≤ 10% within 1 month before enrolling (adjustment = (the maximum dose within a month - the minimum dose) / Final dose (dose of the day before the visit) × 100%);
4. have a HbAlc value (detected by NGSP approved method) between 7.5-11% ;
5. BMI ≤ 32kg / m2, the body weight remained relatively stable, body weight change of no more than 10% at least 3 months before screening,
6. Male subjects hemoglobin≥12g/dl (≥ 120g / L), female subjects hemoglobin ≥ 11g / dl (≥ 110g / L);
7. serum creatinine \<1.5 mg / dL for male subjects, serum creatinine \<1.4 mg / dL for female subjects;
8. have not participated in other clinical studies related diabetes treatment within 3 months ;
9. be volunteered to participate in this clinical study and signed informed consent.
Exclusion Criteria:
1. the persons who attend or perform this study;
2. women in pregnancy or lactation;
3. have frequent severe hypoglycaemia in one month; have blood glucose control adverse events like diabetic ketoacidosis or hyperosmotic diabetic coma within half a year;
4. have severe cardiovascular events in the past 6 months, such as myocardial infarction, acute coronary syndrome, cerebral infarction, cardiovascular and cerebrovascular surgery;
5. have used hormones or immunosuppressive agents, or have immunologic deficiency disease;
6. have end-stage renal disease, and are receiving dialysis treatment;
7. have of history of cancer within 5 years;
8. have history of severe mental instability;
9. have long-term alcohol abuse or drug abuse history;
10. have Skin lesions in the insulin injection site;
11. have history of anemia caused by hemoglobinopathy (such as sickle cell red blood cell anemia, thalassemia, sideroblastic anemia) or any other course;
12. have critically ill, or life expectancy is less than one year;
13. difficult to evaluate the effectiveness and safety of the device intervention;
14. have a clear infection history within a month, such as pneumonia;
15. have active liver disease (AST\> 3 times of normal upper limit or ALT\> 3 times of normal upper limit);
16. have history of acute pancreatitis within a month;
17. have history of insulin allergy;
18. have been expected to have poor compliance and can not be treated according to the research protocol;
19. other cases that investigators believe that the subject may fail to complete the study or may have a significant impact.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03243903
Study Brief:
Protocol Section:
NCT03243903