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

NCT06031987 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

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).

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Kangbuk Samsung Hospital

    lead OTHER

Principal Investigators

  • Cheol-Young Park, MD · KangbukSamsung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2024-01-26
Completion
2024-12-30
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06031987 on ClinicalTrials.gov