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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Injection; Gestational Diabetes; Blood Glucose, High; Glycemic Control
• Intervention / Treatment: Device: Needle-free injection device, Then traditional insulin pen; Device: Traditional insulin pen , Then Needle-free injection device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: cuihua Xie; Phone Number: (+86)020-61641633; Email: xch71@126.com
• Study Contact Backup: Name: jimin Li; Phone Number: (+86)020-61641637; Email: lijimin770815@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: jimin Li; Phone Number: (+86)020-61641637; Email: lijimin770815@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Needle-free injection first group; Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks.	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.
Other: Traditional insulin pen first group; Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: yaoming Xue, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: NFEC-2019-257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No