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

NCT06031987 | Unknown FDA Device

• 1 other identifier: GDMLIBRE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (53)

• AbA1C (%)

  at visit 4(gestational age 36weeks)

• Glycated Albumin(g/dL)

  at visit 4(gestational age 36weeks)

• >180 mg/dL Time in Range

  1 week before Visit4 (gestational age 36weeks)

• >140 mg/dL Time in Range

  1 week before Visit4 (gestational age 36weeks)

• >120 mg/dL Time in Range

  1 week before Visit4 (gestational age 36weeks)

Study Arms (2)

SMBG arm

ACTIVE COMPARATOR

Self Monitoring of Blood Glucose group

Device: CareSens N (iSENS)

CGMS arm

EXPERIMENTAL

Continuous glucose monitoring system, CGM

Device: Freestyle Libre (Abbott)

Interventions

CareSens N (iSENS) DEVICE

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

SMBG arm

Freestyle Libre (Abbott) DEVICE

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

CGMS arm

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: Gestational Diabetes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged female
• Gestational diabetes diagnosed at 24 to 28 weeks of pregnancy screening (stage 1 or stage 2 approach)
• 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
• 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,
• g oral glucose tolerance test 2 or more of the following
• Fasting blood glucose 95mg/dL or higher
• Blood glucose 180mg/dL or higher 1 hour after glucose loading
• Blood glucose of 155 mg/dL or higher 2 hours after glucose loading
• Blood glucose of 140 mg/dL or higher 3 hours after glucose loading
• Singleton Pregnancy

You may not qualify if:

• \- pregestational diabetes (Overt diabetes)
• Diabetes Before Pregnancy
• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Kangbuk Samsung hospital

Seoul, South Korea

RECRUITING

Related 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 Initiative. Am J Epidemiol. 2016 Apr 1;183(7):622-33. doi: 10.1093/aje/kwv241. Epub 2016 Mar 2.

  PMID: 26940115 RESULT

• 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.

  PMID: 24300020 RESULT

• 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.

  PMID: 30396252 RESULT

• 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.

  PMID: 27046149 RESULT

• 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.

  PMID: 24945238 RESULT

• 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.

  PMID: 31296866 RESULT

Related 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 Officials

• Cheol-Young Park, MD

  KangbukSamsung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheol-Young Park, MD

CONTACT

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

SunJoon Moon, MD

CONTACT

ipleat.m@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, parallel, open labeled study

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: September 11, 2023
• Study Start: January 26, 2022
• Primary Completion: January 26, 2024
• Study Completion: December 30, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

KR (1)