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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle-free injection first group | Experimental | Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks. |
|
| Traditional insulin pen first group | Other | Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle-free injection device, Then traditional insulin pen | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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). | 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). | Baseline, week 2, week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cuihua Xie | Contact | (+86)020-61641633 | xch71@126.com | |
| jimin Li | Contact | (+86)020-61641637 | lijimin770815@126.com |
| Name | Affiliation | Role |
|---|---|---|
| yaoming Xue | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, southern medical university | Recruiting | Guangzhou | Guangdong | 510515 | China |
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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.
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|
| Traditional insulin pen , Then Needle-free injection device | 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. |
|
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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