Gestational Diabetes Mellitus in Pregnancy
Conditions
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.
Interventions
DEVICECareSens N (iSENS)
Control group is asked to perform SMBG (4 times or more per day).
DEVICEFreestyle Libre (Abbott)
CGM group is asked to scan CGM (4 times or more per day).
Sponsors
Daewoong Pharmaceutical Co. LTD.
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Open label
Intervention model description
randomized, parallel, open labeled study
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Glycated Albumin(g/dL) | at visit 4(gestational age 36weeks) | Glycated Albumin evaluated at visit 4 |
| >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 |
| >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 |
| <63mg/dL Time in Range | 1 week before Visit4 (gestational age 36weeks) | \<63mg/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 |
| 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) ≥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 |
| 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 |
| Overall average blood glucose level | 1 week before Visit4 (gestational age 36weeks) | Overall average blood glucose level evaluated for 1week 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 |
| 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) |
| glucose variability | 1 week before Visit4(gestational age 36weeks) | glucose variability evaluated for 1week before visit4 (MAGE,SD,CV) |
| rate of insulin treatment | From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week) | rate of insulin treatment |
| 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 |
| 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) |
| 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 |
| C-section rate | during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) | C-section rate |
| preeclampsia rate | during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) | preeclampsia rate |
| preeclampsia or gestational hypertension rate | during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) | preeclampsia or gestational hypertension rate |
| the rate of preterm birth | during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) | the rate of preterm birth |
| 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 |
| 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 |
| Changes in Microbiome | during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) | Changes in Microbiome |
| Rate of transition to type 2 diabetes | at post partum (6-12 weeks after delivery) | Rate of transition to type 2 diabetes |
| 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 |
| 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 |
| 75g OGTT hourly blood glucose | at post partum (6-12 weeks after delivery) | 75g OGTT hourly blood glucose |
| hemoglobinA1C | at post partum (6-12 weeks after delivery) | hemoglobinA1C |
| glycated albumin | at post partum (6-12 weeks after delivery) | glycated albumin |
| Insulin resistance index (HOMA-IR) | at post partum (6-12 weeks after delivery) | HOMA-IR (no unit, higher score means a worse outcome) |
| Insulin resistance index (Matsuda index) | at post partum (6-12 weeks after delivery) | Matsuda 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 secretion ability index (Insulinogenic index) | at post partum (6-12 weeks after delivery) | Insulinogenic index(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) |
| Insulin Composite index(disposition index) | at post partum (6-12 weeks after delivery) | disposition index(no unit, higher score means a better outcome) |
| weight change | at post partum (6-12 weeks after delivery) | weight change |
| Change in Bioelectric impedance analysis (BIA) | at post partum (6-12 weeks after delivery) | Change in Bioelectric impedance analysis (BIA) |
| fetal: childbirth weight | at Delivery | fetal: childbirth weight |
| fetal: Macrosomia ( > 4000 g) | at Delivery | fetal: Macrosomia ( \> 4000 g) |
| 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) |
| AbA1C (%) | at visit 4(gestational age 36weeks) | HbA1C evaluated at visit 4 |
| fetal:NICU admission | at Delivery | fetal:NICU admission |
| 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: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 |
| fetal:Meconium aspiration | at Delivery | fetal:Meconium aspiration |
| fetal:Neonatal glucose level | at Delivery | fetal:Neonatal glucose level |
Countries
South Korea
Contacts
Primary ContactCheol-Young Park, MD
Backup ContactSunJoon Moon, MD
Outcome results
None listed