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

Brief Summary

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 the study period, scanning four or more times per day. The control group will be instructed to perform Self-Monitoring Blood Glucose (SMBG), also four or more times per day. Eligible participants are those within 24 to 30 weeks of gestation (Visit 0). These subjects will undergo a 1-week run-in period, during which they will wear a retrospective CGM device and perform SMBG four or more times daily as a part of the screening process (Visit 1). Following the run-in period, subjects will be randomly assigned to either the CGM group (using the Freestyle Libre device) or the Control group (using SMBG). Members of the control group will be asked to perform SMBG four or more times daily, while those in the CGM group will be instructed to scan their CGM four or more times per day. Participants will have clinic visits at intervals ranging from 2 to 4 weeks, the frequency of which will be determined at the discretion of the attending physician (Visits 2, 2', 2'', 2''', 2'''). Upon reaching gestational age 34-35 weeks (Visit 3), members of the control group will begin to wear a retrospective CGM device until they reach gestational age 36 weeks (Visit 4). After 6-12 weeks from delivery, subjects will be asked to visit the clinic again and undergo a 75g Oral Glucose Tolerance Test (OGTT) (Visit 5). For the purposes of data analysis and outcome determination, the most recent 1-week CGM data collected at Visit 4 will be used for both groups.

Primary Outcomes

Secondary Outcomes

• weight change(at post partum (6-12 weeks after delivery))
• fetal: Macrosomia ( > 4000 g)(at Delivery)
• >180 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Insulin resistance index (HOMA-IR)(at post partum (6-12 weeks after delivery))
• Insulin secretion ability index (HOMA-beta)(at post partum (6-12 weeks after delivery))
• Insulin Composite index(Oral disposition index)(at post partum (6-12 weeks after delivery))
• 63-120mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• <63mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Overall average blood glucose level(1 week before Visit4 (gestational age 36weeks))
• rate of insulin treatment(From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week))
• AbA1C (%)(at visit 4(gestational age 36weeks))
• Glycated Albumin(g/dL)(at visit 4(gestational age 36weeks))
• >140 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• >120 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• <54mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Average daily blood glucose measurements during the study period(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• preeclampsia rate(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• the rate of preterm birth(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• Weight gain during the study period(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• Rate of transition to type 2 diabetes(at post partum (6-12 weeks after delivery))
• Rate of transition to Impaired fasting glucose (IGT) and/or diabetes(at post partum (6-12 weeks after delivery))
• hemoglobinA1C(at post partum (6-12 weeks after delivery))
• Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range(1 week before Visit4 (gestational age 36weeks))
• Overall average Night time Blood glucose (0AM-6AM) level(1 week before Visit4 (gestational age 36weeks))
• Overall average During the day time blood glucose (6AM-12PM) level(1 week before Visit4 (gestational age 36weeks))
• glucose variability(1 week before Visit4(gestational age 36weeks))
• Satisfaction Questionnaire(Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week))
• Rate of transition to Glucose intolerance (prediabetes and/or diabetes)(at post partum (6-12 weeks after delivery))
• Rate of transition to Impaired fasting glucose (IFG) and/or diabetes(at post partum (6-12 weeks after delivery))
• Insulin resistance index (Matsuda index)(at post partum (6-12 weeks after delivery))
• Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)(From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week))
• Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit(1 week before Visit4(Gestational age 36 week))
• C-section rate(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• preeclampsia or gestational hypertension rate(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• 75g OGTT hourly blood glucose(at post partum (6-12 weeks after delivery))
• fetal:Large for gestational age ( > 90th percentile for age)(at Delivery)
• fetal:Small for gestational age ( < 10th percentile for age)(at Delivery)
• fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)(at Delivery)
• fetal:Meconium aspiration(at Delivery)
• Total daily insulin requirements (evaluated at every visit)(From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week))
• Changes in Microbiome(during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks))
• glycated albumin(at post partum (6-12 weeks after delivery))
• Insulin secretion ability index (Insulinogenic index)(at post partum (6-12 weeks after delivery))
• fetal: childbirth weight(at Delivery)
• fetal:NICU admission(at Delivery)
• Insulin Composite index(disposition index)(at post partum (6-12 weeks after delivery))
• Change in Bioelectric impedance analysis (BIA)(at post partum (6-12 weeks after delivery))
• fetal:Neonatal glucose level(at Delivery)
• fetal:Pre-term birth(at Delivery)
• fetal:Apgar score(at Delivery)