Other Clinical Trial - Long-term Effects of Flash Glucose Monitoring

Status Recruiting

Clinical Trial Summary

The purpose of this study is to report the glycemic control effect and clinical safety and effectiveness of mother and fetus when using a continuous glucose monitoring system (CGM) [Freestyle Libre] for a long period of time compared to self monitoring blood glucose(SMBG) in gestational diabetes patients.

Clinical Trial Description

The investigators plan to conduct a randomized clinical trial among patients with Gestational Diabetes Mellitus (GDM). The intervention group will use Continuous Glucose Monitoring (CGM) throughout the study period, scanning four or more times per day. The control group will be instructed to perform Self-Monitoring Blood Glucose (SMBG), also four or more times per day. Eligible participants are those within 24 to 30 weeks of gestation (Visit 0). These subjects will undergo a 1-week run-in period, during which they will wear a retrospective CGM device and perform SMBG four or more times daily as a part of the screening process (Visit 1). Following the run-in period, subjects will be randomly assigned to either the CGM group (using the Freestyle Libre device) or the Control group (using SMBG). Members of the control group will be asked to perform SMBG four or more times daily, while those in the CGM group will be instructed to scan their CGM four or more times per day. Participants will have clinic visits at intervals ranging from 2 to 4 weeks, the frequency of which will be determined at the discretion of the attending physician (Visits 2, 2', 2'', 2''', 2'''). Upon reaching gestational age 34-35 weeks (Visit 3), members of the control group will begin to wear a retrospective CGM device until they reach gestational age 36 weeks (Visit 4). After 6-12 weeks from delivery, subjects will be asked to visit the clinic again and undergo a 75g Oral Glucose Tolerance Test (OGTT) (Visit 5). For the purposes of data analysis and outcome determination, the most recent 1-week CGM data collected at Visit 4 will be used for both groups. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus
Diabetes, Gestational
Gestational Diabetes Mellitus in Pregnancy
Pregnancy in Diabetics

Clinical Trial Details

NCT number	NCT06031987
Study type	Interventional
Source	Kangbuk Samsung Hospital
Contact	Cheol-Young Park, MD
Phone	82-010-3397-6107
Email	cydoctor68@gmail.com
Status	Recruiting
Phase	N/A
Start date	January 26, 2022
Completion date	December 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes — GDMLIBRE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms