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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: The needle-free jet injector


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days | Device: The needle-free jet injector<br>* Continuous insulin therapy for 9 days<br>|
| Experimental: Group B<br>The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days | Device: The needle-free jet injector<br>* Continuous insulin therapy for 9 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose profile | changes of blood glucose profile | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity Questionnaire of Patients | changes of Sensitivity Questionnaire of Patients | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring