NCT06031987

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DEVICE	CareSens N (iSENS)	Control group is asked to perform SMBG (4 times or more per day).
DEVICE	Freestyle Libre (Abbott)	CGM group is asked to scan CGM (4 times or more per day).

Timeline

• Start date: 2022-01-26
• Primary completion: 2024-01-26
• Completion: 2024-12-30
• First posted: 2023-09-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study