Status:
UNKNOWN
Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
Lead Sponsor:
Kangbuk Samsung Hospital
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
19-40 years
Phase:
NA
Brief 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) \[Freestyle Libre\]...
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 th...
Eligibility Criteria
Inclusion
- \[Inclusion Criteria\]
- 19-40 aged female
- Gestational diabetes diagnosed at 24 to 28 weeks of pregnancy screening (stage 1 or stage 2 approach)
- 2-1.Screening one-step approach (75g oral glucose tolerance test, diagnosed when one or more of the following)
- Fasting blood glucose 92 mg/dL or higher
- Blood glucose 180 mg/dL or higher 1 hour after glucose loading
- Blood glucose of 153 mg/dL or higher 2 hours after glucose loading
- 2-2. Screening two-step approach (50 g oral glucose tolerance test then,100g oral glucose tolerance test)
- If the blood glucose level is 140 mg/dL or higher for 1 hour after the 50g oral glucose tolerance test,
- 100g oral glucose tolerance test 2 or more of the following
- Fasting blood glucose 95mg/dL or higher
- Blood glucose 180mg/dL or higher 1 hour after glucose loading
- Blood glucose of 155 mg/dL or higher 2 hours after glucose loading
- Blood glucose of 140 mg/dL or higher 3 hours after glucose loading
- Singleton Pregnancy
- \[Exclusion Criteria\]
- \- pregestational diabetes (Overt diabetes)
- Diabetes Before Pregnancy
- At least one of the following at the first prenatal visit
- Fasting blood glucose 126mg/dL or higher
- Random blood glucose 200mg/dL or higher
Exclusion
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06031987
Start Date
January 26 2022
End Date
December 30 2024
Last Update
September 11 2023
Active Locations (1)
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1
Kangbuk Samsung hospital
Seoul, South Korea