Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05394727
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2022-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes Mellitus
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
Application of Needle-free Injection of Insulin in Pregnant Women With Gestational Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: