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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006454
Enrollment
100
Registered
2021-08-17
Start date
2021-08-31
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 1. Subjects allocated to Freestyle Libre group - Training on how to apply and how to use the application. - If you have hyperglycemia or hypoglycemia, but there is a difference from F

Sponsors

Kangbuk Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ?Woman 19–40 years old ?Pregnancy diabetes diagnosed in 24-28 weeks of pregnancy screening (step 1 or 2 approach). -Selection Inspection Phase 1 Approach (75g Oral Burden Inspection, diagnosis of one or more of the following) 92 mg/dL or more of empty blood sugar Blood sugar greater than 180 mg/dL for 1 hour after application Blood sugar at least 153 mg/dL for 2 hours after application -Selection inspection stage 2 approach (50 g oral load inspection g 100 g oral glucose inspection) 50 g oral pressure test and blood sugar is 140 mg/dL or more for 1 hour. 100 g oral load test (2 or more of the following) 95 mg/dL or more of empty blood sugar Blood sugar greater than 180 mg/dL for 1 hour after application Blood sugar is 155 mg/dL or more for 2 hours after application. Blood sugar is 140 mg/dL or more for 3 hours after application. ?single pregnancy

Exclusion criteria

Exclusion criteria: ?pre-existing diagnosis of pre-pregnancy diabetes ?Satisfaction with one of the following during the first prenatal visit: Hunger blood sugar above 126 mg/dL Random blood sugar above 200 mg/dL 6.5% or more glycated hemoglobin ?30 weeks of gestation + 6 days of age (at the time of screening) ?multiple pregnancy ?fetal deformity ?If you have a history of stillbirth (delivery of a fetus that died after 20 weeks of pregnancy) ?If you smoke within six months, ?Chronic kidney disease, cirrhosis, cancer (if thyroid cancer is stable, it can be registered by researchers), heart failure, hypertension (including pregnancy hypertension and electromagnetic liver disease), autoimmune disease (SLE), unregulated hyperthyroidism and hypothyroidism (regulated). ?chronically ill people who are judged to have hindered the performance of research by researchers ?If you have a mental illness that requires hospitalization within six months, ?If you have a history of taking fetal-deformity drugs during pregnancy ?A person who uses a continuous blood glucose meter during pregnancy until research registration.

Design outcomes

Primary

MeasureTime frame
63-140 mg/dL target time evaluated by continuous blood glucose measurement for a week before Visit 4 visit

Secondary

MeasureTime frame
HbA1c during Visit4 ;Glycated Albumin during Visit4 ;TIR evaluated by continuous blood glucose measurement for a week before Visit4.;Frequency of severe hypoglycemia during the study.;Glucose variability for a week before the visit4;Estimated A1c for a week before the visit4;Insulin Treatment Rate;Total insulin requirements per day

Countries

Korea, Republic of

Contacts

Public ContactCheol Young Park

Kangbuk Samsung Medical Center

cydoctor@chol.com+82-2-2001-1555

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026