Diabetes Mellitus, Type 2
Conditions
Keywords
Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring
Brief summary
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen
Detailed description
Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile of CGMS and safety in type 2 diabetic patients.
Interventions
Continuous insulin therapy for 9 days
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months. * No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. * Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Exclusion criteria
* Patients with insulin allergy. * Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal. * Drug abuse and alcohol dependence in the past 5 years. * Systemic hormone therapy was used in the last three months. * Patients with poor compliance and irregular diet and exercise. * Patients with pregnancy, lactation or pregnancy intention. * Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose profile | 9 days | changes of blood glucose profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity Questionnaire of Patients | 9 days | changes of Sensitivity Questionnaire of Patients |
Contacts
Primary ContactJianhua Ma
Outcome results
None listed