Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Device: Freestyle Libre (Abbott)Device: CareSens N (iSENS)
- Registration Number
- NCT06031987
- Lead Sponsor
- Kangbuk Samsung Hospital
- 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) \[Freestyle Libre\] for a long period of time compared to self monitoring blood glucose(SMBG) in gestational diabetes patients.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CGMS arm Freestyle Libre (Abbott) Continuous glucose monitoring system, CGM SMBG arm CareSens N (iSENS) Self Monitoring of Blood Glucose group
- Primary Outcome Measures
Name Time Method 63-140 mg/dL Time in Range at visit 4(gestational age 36weeks) 63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit
- Secondary Outcome Measures
Name Time Method glucose variability 1 week before Visit4(gestational age 36weeks) glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)
Insulin Composite index(disposition index) at post partum (6-12 weeks after delivery) disposition index(no unit, higher score means a better outcome)
Insulin secretion ability index (HOMA-beta) at post partum (6-12 weeks after delivery) HOMA-beta(no unit, higher score means a better outcome)
Insulin Composite index(Oral disposition index) at post partum (6-12 weeks after delivery) Oral disposition index(no unit, higher score means a better outcome)
>180 mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) \>180 mg/dL Time in Range evaluated for 1 week before Visit4
Insulin resistance index (HOMA-IR) at post partum (6-12 weeks after delivery) HOMA-IR (no unit, higher score means a worse outcome)
weight change at post partum (6-12 weeks after delivery) weight change
fetal: Macrosomia ( > 4000 g) at Delivery fetal: Macrosomia ( \> 4000 g)
63-120mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) 63-120mg/dL Time in Range evaluated for 1 week before Visit4
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) 63-94 mg/dL Time in Range evaluated for 1 week before Visit4
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) \<63 mg/dL Time in Range evaluated for 1 week before Visit4
Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) Night time Blood glucose (0AM-6AM) \<54 mg/dL Time in Range evaluated for 1 week before Visit4
<63mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) \<63mg/dL Time in Range evaluated for 1 week before Visit4
Overall average blood glucose level 1 week before Visit4 (gestational age 36weeks) Overall average blood glucose level evaluated for 1week before visit4
rate of insulin treatment From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week) rate of insulin treatment
the rate of preterm birth during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) the rate of preterm birth
C-section rate during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) C-section rate
Weight gain during the study period during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) Weight gain during the study period
Rate of transition to type 2 diabetes at post partum (6-12 weeks after delivery) Rate of transition to type 2 diabetes
AbA1C (%) at visit 4(gestational age 36weeks) HbA1C evaluated at visit 4
Glycated Albumin(g/dL) at visit 4(gestational age 36weeks) Glycated Albumin evaluated at visit 4
>140 mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) \>140 mg/dL Time in Range evaluated for 1 week before Visit4
>120 mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) \>120 mg/dL Time in Range evaluated for 1 week before Visit4
<54mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) \<54mg/dL Time in Range evaluated for 1 week before Visit4
preeclampsia rate during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) preeclampsia rate
Rate of transition to Impaired fasting glucose (IGT) and/or diabetes at post partum (6-12 weeks after delivery) Rate of transition to Impaired fasting glucose (IGT) and/or diabetes
hemoglobinA1C at post partum (6-12 weeks after delivery) hemoglobinA1C
Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range 1 week before Visit4 (gestational age 36weeks) Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range evaluated for 1 week before Visit4
Overall average Night time Blood glucose (0AM-6AM) level 1 week before Visit4 (gestational age 36weeks) Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4
Overall average During the day time blood glucose (6AM-12PM) level 1 week before Visit4 (gestational age 36weeks) Overall average During the day time blood glucose (6AM-12PM) level evaluated for 1week before visit4
Satisfaction Questionnaire Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week) Satisfaction Questionnaire(DTSQ) ,Score: min0 \~max 48, higher scores mean a better outcome
Average daily blood glucose measurements during the study period during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) Freestyle Libre scans, SMBG
Rate of transition to Glucose intolerance (prediabetes and/or diabetes) at post partum (6-12 weeks after delivery) Rate of transition to Glucose intolerance (prediabetes and/or diabetes)
Rate of transition to Impaired fasting glucose (IFG) and/or diabetes at post partum (6-12 weeks after delivery) Rate of transition to Impaired fasting glucose (IFG) and/or diabetes
Insulin resistance index (Matsuda index) at post partum (6-12 weeks after delivery) Matsuda index (no unit, higher score means a better outcome)
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) Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)
Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit 1 week before Visit4(Gestational age 36 week) Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit
preeclampsia or gestational hypertension rate during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) preeclampsia or gestational hypertension rate
75g OGTT hourly blood glucose at post partum (6-12 weeks after delivery) 75g OGTT hourly blood glucose
fetal:Large for gestational age ( > 90th percentile for age) at Delivery fetal:Large for gestational age ( \> 90th percentile for age)
fetal:Small for gestational age ( < 10th percentile for age) at Delivery fetal:Small for gestational age ( \< 10th percentile for age)
fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy) at Delivery fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)
fetal:Meconium aspiration at Delivery fetal:Meconium aspiration
Total daily insulin requirements (evaluated at every visit) From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week) Total daily insulin requirements (evaluated at every visit)
Changes in Microbiome during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) Changes in Microbiome
glycated albumin at post partum (6-12 weeks after delivery) glycated albumin
Insulin secretion ability index (Insulinogenic index) at post partum (6-12 weeks after delivery) Insulinogenic index(no unit, higher score means a better outcome)
fetal: childbirth weight at Delivery fetal: childbirth weight
fetal:NICU admission at Delivery fetal:NICU admission
Change in Bioelectric impedance analysis (BIA) at post partum (6-12 weeks after delivery) Change in Bioelectric impedance analysis (BIA)
fetal:Neonatal glucose level at Delivery fetal:Neonatal glucose level
fetal:Pre-term birth at Delivery fetal:Pre-term birth
fetal:Apgar score at Delivery score: min 0 \~ max 10, higher scores mean a better outcome
Trial Locations
- Locations (1)
Kangbuk Samsung hospital
🇰🇷Seoul, Korea, Republic of