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

Primary Purpose

Injection, Blood Glucose, High, Glycemic Control

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Needle-free injection device, Then traditional insulin pen

Traditional insulin pen , Then Needle-free injection device

About this trial

This is an interventional other trial for Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Nanfang Hospital, southern medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Needle-free injection first group

Traditional insulin pen first group

Arm Description

Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks.

Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks.

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05394727

First Posted

May 17, 2022

Last Updated

March 28, 2023

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05394727

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Needle-free injection first group

Arm Type

Experimental

Arm Description

Use needle-free syringe for insulin injection in patients for 2 weeks, then replace it with conventional insulin pen injection for another 2 weeks.

Arm Title

Traditional insulin pen first group

Arm Type

Other

Arm Description

Use conventional insulin pen for insulin injection in patients for 2 weeks, then replace it with needle-free syringe injection for another 2 weeks.

Intervention Type

Device

Intervention Name(s)

Needle-free injection device, Then traditional insulin pen

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Traditional insulin pen , Then Needle-free injection device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in Blood Glucose Indicators to week 4

Description

Time Frame

Baseline, week 2, week 4

Title

Change from baseline in Plasma insulin concentrations to week 4

Description

Time Frame

Baseline, week 2, week 4

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

cuihua Xie

Phone

(+86)020-61641633

xch71@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

jimin Li

Phone

(+86)020-61641637

lijimin770815@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yaoming Xue

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanfang Hospital, southern medical university

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jimin Li

Phone

(+86)020-61641637

lijimin770815@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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