Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Blood glucose profile
研究概览
简要总结
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A
The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days
干预措施: The needle-free jet injector (Device)
Group B
The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days
干预措施: The needle-free jet injector (Device)
结局指标
主要结局
Blood glucose profile
时间窗: 9 days
changes of blood glucose profile
次要结局
- Sensitivity Questionnaire of Patients(9 days)