Blood Glucose, High, Gestational Diabetes, Glycemic Control, Injection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICENeedle-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.
DEVICETraditional 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Test group: use needle-free syringe for insulin injection and replace it with conventional insulin pen injection after 2 weeks. Control group: use traditional insulin pen injection and replace it with needle-free syringe after 2 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Blood Glucose Indicators to week 4 | 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 | 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). |
Countries
China
Contacts
Primary Contactcuihua Xie
Backup Contactjimin Li
Outcome results
None listed