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

NCT05394727 | Unknown

• 1 other identifier: NFEC-2019-257
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection; Blood Glucose, High; Glycemic Control; Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Device: Needle-free injection device, Then traditional insulin pen

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.

Device: Traditional insulin pen , Then Needle-free injection device

Interventions

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.

Needle-free injection first group

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.

Traditional insulin pen first group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• yaoming Xue

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cuihua Xie

CONTACT

(+86)020-61641633; xch71@126.com

jimin Li

CONTACT

(+86)020-61641637; lijimin770815@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 27, 2022
• Study Start: April 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)