Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: The needle-free jet injector

• Registration Number: NCT04093284
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-12
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18
• Primary Completion: 2019-10-20
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	The needle-free jet injector	The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days
Group B	The needle-free jet injector	The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days

Primary Outcome Measures

Name	Time	Method
Blood glucose profile	9 days	changes of blood glucose profile

Secondary Outcome Measures

Name	Time	Method
Sensitivity Questionnaire of Patients	9 days	changes of Sensitivity Questionnaire of Patients