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

Launched by KANGBUK SAMSUNG HOSPITAL · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of using a continuous glucose monitoring system (CGM), specifically the Freestyle Libre, in women with gestational diabetes. This type of diabetes occurs during pregnancy and can affect both the mother and the baby. The trial aims to see how well this monitoring system helps control blood sugar levels compared to traditional methods of checking blood sugar with a finger prick, known as self-monitoring blood glucose (SMBG). The researchers will look at both the health of the mother and the baby over time.

To participate in this study, women must be between 19 and 40 years old and have been diagnosed with gestational diabetes during their pregnancy, typically between 24 and 28 weeks. They should also be having a single baby (singleton pregnancy). Participants will regularly use the CGM to track their blood sugar levels and will be monitored to ensure their safety and the health of their baby throughout the trial. If you or someone you know meets these criteria, this study could provide important insights into managing gestational diabetes.

Gender

FEMALE

Eligibility criteria

• • \[Inclusion Criteria\]
• • 1. 19-40 aged female
• • 2. 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
• • 1. Fasting blood glucose 95mg/dL or higher
• • 2. Blood glucose 180mg/dL or higher 1 hour after glucose loading
• • 3. Blood glucose of 155 mg/dL or higher 2 hours after glucose loading
• • 4. Blood glucose of 140 mg/dL or higher 3 hours after glucose loading
• • 3. Singleton Pregnancy
• • \[Exclusion Criteria\]
• • - pregestational diabetes (Overt diabetes)
• • 1. Diabetes Before Pregnancy
• • 2. 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