Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen

Jian-hua Ma

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Device: Conventional insulin pen

Device: The needle-free jet injector

Study type

Interventional

Funder types

Other

Identifiers

NCT04074603

KY20190530-02-KS-01

Details and patient eligibility

About

To comparing the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

Full 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 and safety in type 2 diabetic patients.

Enrollment

150 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

volunteer to participate and be able to sign informed consent prior to the trial.
patients with type 2 diabetes, aged 18-80 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (4-35 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.