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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

— GDMLIBRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031987
• Other study ID #: GDMLIBRE
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Kangbuk Samsung Hospital
• Contact: Cheol-Young Park, MD
• Phone: 82-010-3397-6107
• Email: cydoctor68[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

[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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Device:
• CareSens N (iSENS)
Control group is asked to perform SMBG (4 times or more per day).
• Freestyle Libre (Abbott)
CGM group is asked to scan CGM (4 times or more per day).

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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 Initiat — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AbA1C (%)	HbA1C evaluated at visit 4	at visit 4(gestational age 36weeks)
Secondary	Glycated Albumin(g/dL)	Glycated Albumin evaluated at visit 4	at visit 4(gestational age 36weeks)
Secondary	>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)
Secondary	>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)
Secondary	>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)
Secondary	<63mg/dL Time in Range	<63mg/dL Time in Range evaluated for 1 week before Visit4	1 week before Visit4 (gestational age 36weeks)
Secondary	<54mg/dL Time in Range	<54mg/dL Time in Range evaluated for 1 week before Visit4	1 week before Visit4 (gestational age 36weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Overall average blood glucose level	Overall average blood glucose level evaluated for 1week before visit4	1 week before Visit4 (gestational age 36weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	glucose variability	glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)	1 week before Visit4(gestational age 36weeks)
Secondary	rate of insulin treatment	rate of insulin treatment	From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	C-section rate	C-section rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Secondary	preeclampsia rate	preeclampsia rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Secondary	preeclampsia or gestational hypertension rate	preeclampsia or gestational hypertension rate	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Secondary	the rate of preterm birth	the rate of preterm birth	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Secondary	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)
Secondary	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)
Secondary	Changes in Microbiome	Changes in Microbiome	during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
Secondary	Rate of transition to type 2 diabetes	Rate of transition to type 2 diabetes	at post partum (6-12 weeks after delivery)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	75g OGTT hourly blood glucose	75g OGTT hourly blood glucose	at post partum (6-12 weeks after delivery)
Secondary	hemoglobinA1C	hemoglobinA1C	at post partum (6-12 weeks after delivery)
Secondary	glycated albumin	glycated albumin	at post partum (6-12 weeks after delivery)
Secondary	Insulin resistance index (HOMA-IR)	HOMA-IR (no unit, higher score means a worse outcome)	at post partum (6-12 weeks after delivery)
Secondary	Insulin resistance index (Matsuda index)	Matsuda index (no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Secondary	Insulin secretion ability index (HOMA-beta)	HOMA-beta(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Secondary	Insulin secretion ability index (Insulinogenic index)	Insulinogenic index(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Secondary	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)
Secondary	Insulin Composite index(disposition index)	disposition index(no unit, higher score means a better outcome)	at post partum (6-12 weeks after delivery)
Secondary	weight change	weight change	at post partum (6-12 weeks after delivery)
Secondary	Change in Bioelectric impedance analysis (BIA)	Change in Bioelectric impedance analysis (BIA)	at post partum (6-12 weeks after delivery)
Secondary	fetal: childbirth weight	fetal: childbirth weight	at Delivery
Secondary	fetal: Macrosomia ( > 4000 g)	fetal: Macrosomia ( > 4000 g)	at Delivery
Secondary	fetal:Large for gestational age ( > 90th percentile for age)	fetal:Large for gestational age ( > 90th percentile for age)	at Delivery
Secondary	fetal:Small for gestational age ( < 10th percentile for age)	fetal:Small for gestational age ( < 10th percentile for age)	at Delivery
Secondary	fetal:Neonatal glucose level	fetal:Neonatal glucose level	at Delivery
Secondary	fetal:NICU admission	fetal:NICU admission	at Delivery
Secondary	fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)	fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)	at Delivery
Secondary	fetal:Pre-term birth	fetal:Pre-term birth	at Delivery
Secondary	fetal:Apgar score	score: min 0 ~ max 10, higher scores mean a better outcome	at Delivery
Secondary	fetal:Meconium aspiration	fetal:Meconium aspiration	at Delivery

External 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].