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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Device: CareSens N (iSENS); Device: Freestyle Libre (Abbott)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheol-Young Park, MD; Phone Number: 82-010-3397-6107; Email: cydoctor68@gmail.com
• Study Contact Backup: Name: SunJoon Moon, MD; Email: ipleat.m@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: Cheol-Young Park, MD; Phone Number: 82-010-3397-6107; Email: cydoctor68@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

[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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMBG arm; Self Monitoring of Blood Glucose group	Device: CareSens N (iSENS); Control group is asked to perform SMBG (4 times or more per day).
Experimental: CGMS arm; Continuous glucose monitoring system, CGM	Device: Freestyle Libre (Abbott); CGM group is asked to scan CGM (4 times or more per day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
63-140 mg/dL Time in Range	63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit	at visit 4(gestational age 36weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AbA1C (%)	HbA1C evaluated at visit 4	at visit 4(gestational age 36weeks)
Glycated Albumin(g/dL)	Glycated Albumin evaluated at visit 4	at visit 4(gestational age 36weeks)
>180 mg/dL Time in Range	>180 mg/dL Time in Range evaluated for 1 week before Visit4	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	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	1 week before Visit4 (gestational age 36weeks)
<63mg/dL Time in Range	<63mg/dL Time in Range evaluated for 1 week before Visit4	1 week before Visit4 (gestational age 36weeks)
<54mg/dL Time in Range	<54mg/dL Time in Range evaluated for 1 week before Visit4	1 week before Visit4 (gestational age 36weeks)
63-120mg/dL Time in Range	63-120mg/dL Time in Range evaluated for 1 week before Visit4	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	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	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	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	1 week before Visit4 (gestational age 36weeks)
Overall average blood glucose level	Overall average blood glucose level evaluated for 1week before visit4	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	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	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)	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)	1 week before Visit4(gestational age 36weeks)
rate of insulin treatment	rate of insulin treatment	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	Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit	1 week before Visit4(Gestational age 36 week)
Total daily insulin requirements (evaluated at every 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)
Satisfaction Questionnaire	Satisfaction Questionnaire(DTSQ) ,Score: min0 ~max 48, higher scores mean a better outcome	Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)
C-section rate	C-section rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
preeclampsia rate	preeclampsia rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
preeclampsia or gestational hypertension rate	preeclampsia or gestational hypertension rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
the rate of preterm birth	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	Weight gain during the study period	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	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Changes in Microbiome	Changes in Microbiome	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Rate of transition to type 2 diabetes	Rate of transition to type 2 diabetes	at post partum (6-12 weeks after delivery)
Rate of transition to Glucose intolerance (prediabetes and/or diabetes)	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	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 (IGT) and/or diabetes	Rate of transition to Impaired fasting glucose (IGT) and/or diabetes	at post partum (6-12 weeks after delivery)
75g OGTT hourly blood glucose	75g OGTT hourly blood glucose	at post partum (6-12 weeks after delivery)
hemoglobinA1C	hemoglobinA1C	at post partum (6-12 weeks after delivery)
glycated albumin	glycated albumin	at post partum (6-12 weeks after delivery)
Insulin resistance index (HOMA-IR)	HOMA-IR (no unit, higher score means a worse outcome)	at post partum (6-12 weeks after delivery)
Insulin resistance index (Matsuda index)	Matsuda index (no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Insulin secretion ability index (HOMA-beta)	HOMA-beta(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Insulin secretion ability index (Insulinogenic index)	Insulinogenic index(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Insulin Composite index(Oral disposition index)	Oral disposition index(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Insulin Composite index(disposition index)	disposition index(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
weight change	weight change	at post partum (6-12 weeks after delivery)
Change in Bioelectric impedance analysis (BIA)	Change in Bioelectric impedance analysis (BIA)	at post partum (6-12 weeks after delivery)
fetal: childbirth weight	fetal: childbirth weight	at Delivery
fetal: Macrosomia ( > 4000 g)	fetal: Macrosomia ( > 4000 g)	at Delivery
fetal:Large for gestational age ( > 90th percentile for age)	fetal:Large for gestational age ( > 90th percentile for age)	at Delivery
fetal:Small for gestational age ( < 10th percentile for age)	fetal:Small for gestational age ( < 10th percentile for age)	at Delivery
fetal:Neonatal glucose level	fetal:Neonatal glucose level	at Delivery
fetal:NICU admission	fetal:NICU admission	at Delivery
fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)	fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)	at Delivery
fetal:Pre-term birth	fetal:Pre-term birth	at Delivery
fetal:Apgar score	score: min 0 ~ max 10, higher scores mean a better outcome	at Delivery
fetal:Meconium aspiration	fetal:Meconium aspiration	at Delivery

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Cheol-Young Park, MD, Kangbuksamsung Hospital

Publications and helpful links

General Publications

• Cespedes EM, Hu FB, Tinker L, Rosner B, Redline S, Garcia L, Hingle M, Van Horn L, Howard BV, Levitan EB, Li W, Manson JE, Phillips LS, Rhee JJ, Waring ME, Neuhouser ML. Multiple Healthful Dietary Patterns and Type 2 Diabetes in the Women's Health Initiative. Am J Epidemiol. 2016 Apr 1;183(7):622-33. doi: 10.1093/aje/kwv241. Epub 2016 Mar 2.
• Guariguata L, Linnenkamp U, Beagley J, Whiting DR, Cho NH. Global estimates of the prevalence of hyperglycaemia in pregnancy. Diabetes Res Clin Pract. 2014 Feb;103(2):176-85. doi: 10.1016/j.diabres.2013.11.003. Epub 2013 Dec 1.
• Kim KS. The importance of treating mild hyperglycemia in pregnant women with diabetes. Korean J Intern Med. 2018 Nov;33(6):1079-1080. doi: 10.3904/kjim.2018.351. Epub 2018 Oct 30. No abstract available.
• Koo BK, Lee JH, Kim J, Jang EJ, Lee CH. Prevalence of Gestational Diabetes Mellitus in Korea: A National Health Insurance Database Study. PLoS One. 2016 Apr 5;11(4):e0153107. doi: 10.1371/journal.pone.0153107. eCollection 2016. Erratum In: PLoS One. 2016 Oct 20;11(10 ):e0165445.
• DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
• McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.

Helpful Links

• Hasain Z, Mokhtar NM , Kamaruddin NA, Mohamed Ismail NA, Razalli NH, Gnanou JV, et al. Gut Microbiota and Gestational Diabetes Mellitus: A Review of Host Gut Microbiota Interactions and Their Therapeutic Potential. Front Cell Infect Microbiol [Internet].

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Estimated): January 26, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: GDMLIBRE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes