Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Official title:

Application of Needle-free Injection of Insulin in Pregnant Women With Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394727
• Other study ID #: NFEC-2019-257
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: cuihua Xie
• Phone: (+86)020-61641633
• Email: xch71[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Glucose, High
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Glycemic Control
• Injection

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital, southern medical university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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