Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
NCT ID: NCT06031987
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-01-26
2024-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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SMBG arm
Self Monitoring of Blood Glucose group
CareSens N (iSENS)
Control group is asked to perform SMBG (4 times or more per day).
CGMS arm
Continuous glucose monitoring system, CGM
Freestyle Libre (Abbott)
CGM group is asked to scan CGM (4 times or more per day).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
40 Years
FEMALE
Yes
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Kangbuk Samsung Hospital
OTHER
Responsible Party
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Cheol-Young Park
Professor
Principal Investigators
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Cheol-Young Park, MD
Role: PRINCIPAL_INVESTIGATOR
KangbukSamsung Hospital
Locations
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Kangbuk Samsung hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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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 \[Internet\].
Other Identifiers
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GDMLIBRE
Identifier Type: -
Identifier Source: org_study_id
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