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

N/AUnknownNCT06031987

Kangbuk Samsung Hospital100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Gestational Diabetes Mellitus in Pregnancy

Interventions

CareSens N (iSENS)DEVICE

Control group is asked to perform SMBG (4 times or more per day).

Freestyle Libre (Abbott)DEVICE

CGM group is asked to scan CGM (4 times or more per day).

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

\[Inclusion Criteria\] 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

Locations (1)

Kangbuk Samsung hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

63-140 mg/dL Time in Range

63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit

Time frame: at visit 4(gestational age 36weeks)

Secondary Outcomes

AbA1C (%)

HbA1C evaluated at visit 4

Time frame: at visit 4(gestational age 36weeks)

Glycated Albumin(g/dL)

Glycated Albumin evaluated at visit 4

Time frame: at visit 4(gestational age 36weeks)

>180 mg/dL Time in Range

\>180 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

>140 mg/dL Time in Range

\>140 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

>120 mg/dL Time in Range

\>120 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

<63mg/dL Time in Range

\<63mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

<54mg/dL Time in Range

\<54mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Central Contacts

Cheol-Young Park, MD

CONTACT

82-010-3397-6107 cydoctor68@gmail.com

SunJoon Moon, MD

CONTACT

ipleat.m@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

63-120mg/dL Time in Range

63-120mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range

Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range

Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range

Night time Blood glucose (0AM-6AM) \<63 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range

Night time Blood glucose (0AM-6AM) \<54 mg/dL Time in Range evaluated for 1 week before Visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Overall average blood glucose level

Overall average blood glucose level evaluated for 1week before visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Overall average Night time Blood glucose (0AM-6AM) level

Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Overall average During the day time blood glucose (6AM-12PM) level

Overall average During the day time blood glucose (6AM-12PM) level evaluated for 1week before visit4

Time frame: 1 week before Visit4 (gestational age 36weeks)

Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)

Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)

Time frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)

glucose variability

glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)

Time frame: 1 week before Visit4(gestational age 36weeks)

rate of insulin treatment

Time frame: 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

Time frame: 1 week before Visit4(Gestational age 36 week)

Total daily insulin requirements (evaluated at every visit)

Time frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)

Satisfaction Questionnaire

Satisfaction Questionnaire(DTSQ) ,Score: min0 \~max 48, higher scores mean a better outcome

Time frame: Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)

C-section rate

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

preeclampsia rate

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

preeclampsia or gestational hypertension rate

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

the rate of preterm birth

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

Weight gain during the study period

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

Average daily blood glucose measurements during the study period

Freestyle Libre scans, SMBG

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

Changes in Microbiome

Time frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

Rate of transition to type 2 diabetes