Application of Needle-free Injection of Insulin in Pregnant Women With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in Blood Glucose Indicators to week 4
研究概览
简要总结
This study is about the application of needle-free injection device in GDM patients in order to observe the variation of blood glucose and patients' experience compared to the traditional insulin pen injection. To provide evidence for the application of needle-free syringe injection in GDM patients.
详细描述
This study is a prospective, randomized, unblinded,crossover and controlled clinical trail. The first patient was enrolled on November 1, 2019. The follow-up visit of all enrolled patients in our center will be finished on June 30, 2021. There are two arms in our study : Test Group(IG,n=20) and Control Group(CG,n=20), 40 patients totally.
Test group: "Needle-free injection device, Then traditional insulin pen" Patients first received needle-free syringe for insulin injection 3~4 times per day for 2 weeks. After the period of 2 weeks, they then received conventional insulin pen for insulin injection 3~4 times per day for 2 weeks.
Control group: "Traditional insulin pen , Then Needle-free injection device" Patients first received conventional insulin pen for insulin injection 3~4 times per day for 2 weeks. After the period of 2 weeks, they then received needle-free syringe for insulin injection 3~4 times per day for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients'diagnostic criteria of gestational diabetes mellitus(GDM) is according to the Guidelines for the prevention and control of type 2 diabetes in China (2017 Edition).
- •fasting glucose or 2h post prandial glucose was abnormal after 3days' dietary control (fasting glucose ≥ 6.1 mmol/L, or 2h post prandial glucose ≥7.8 mmol/L).
- •Aged≥20 years, Han, singleton pregnancy.
- •Patients who gave informed consent voluntarily participated in the study, and had regular perinatal examination at our hospital and intended to deliver at our hospital.
排除标准
- •Patients with multiple pregnancy or undergoing assisted reproductive technology.
- •Patients with polycystic ovary syndrome in preconception.
- •Patients with other endocrine metabolic disorders such as gestational hypertension and hyperthyroidism.
- •Patients with severe anemia and hypoproteinemia, abnormal liver and kidney function, severe heart failure, respiratory failure and other systemic diseases.
- •Patients on long-term medications that affect glucose metabolism.
研究组 & 干预措施
Needle-free injection first group
Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks.
干预措施: Needle-free injection device, Then traditional insulin pen (Device)
Traditional insulin pen first group
Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks.
干预措施: Traditional insulin pen , Then Needle-free injection device (Device)
结局指标
主要结局
Change from baseline in Blood Glucose Indicators to week 4
时间窗: Baseline, week 2, week 4
The blood glucose indicators include fasting blood glucose and blood glucose of 0.5,1,2,3 hours post-meals. Change=(Week 4 blood glucose indicators - Week 2 blood glucose indicators - Baseline blood glucose indicators).
Change from baseline in Plasma insulin concentrations to week 4
时间窗: Baseline, week 2, week 4
The Plasma insulin concentrations include fasting plasma insulin concentration and plasma insulin concentrations of 0.5,1,2,3 hours post-meals. Change=(Week 4 plasma insulin concentrations - Week 2 plasma insulin concentrations - Baseline plasma insulin concentrations).
次要结局
未报告次要终点