Long-term effects of glucose monitoring in pregnant women with diabetes
Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
This study is testing if using a continuous glucose monitor can help pregnant women with gestational diabetes manage their blood sugar better than traditional finger-prick testing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | Kangbuk Samsung Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06031987 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of a continuous glucose monitoring system (CGM) compared to traditional self-monitoring blood glucose (SMBG) in pregnant women diagnosed with gestational diabetes mellitus (GDM). Participants will be randomly assigned to either the CGM group, using the Freestyle Libre device, or the control group, performing SMBG. The study will involve regular clinic visits and glucose testing throughout the pregnancy and a follow-up after delivery to assess long-term glycemic control. The goal is to determine if CGM provides better outcomes for both mothers and their babies.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 19-40 who have been diagnosed with gestational diabetes between 24 to 28 weeks of pregnancy.
Not a fit: Patients who are not diagnosed with gestational diabetes or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and health outcomes for pregnant women with gestational diabetes and their infants.
How similar studies have performed: Previous studies have shown promising results with continuous glucose monitoring in diabetes management, suggesting potential success for this approach in gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Kangbuk Samsung hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Cheol-Young Park, MD — KangbukSamsung Hospital
- Study coordinator: Cheol-Young Park, MD
- Email: cydoctor68@gmail.com
- Phone: 82-010-3397-6107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.