Comparison of Safety and Efficacy of QS-M Needle- Free Injector and Insulin Pen in Controlling T2DM Patient's Glucose

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.