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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
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.
Nanfang Hospital, southern medical university
Guangzhou, Guangdong, China
RECRUITINGChange from baseline in Blood Glucose Indicators to 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).
Time frame: Baseline, week 2, week 4
Change from baseline in Plasma insulin concentrations to 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).
Time frame: Baseline, week 2, week 4
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