Clinical trial NCT06031987: Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
Official title: Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Daewoong Pharmaceutical Co. LTD.
First posted: 2023-09-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel, open labeled study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: \[Inclusion Criteria\]

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

Primary outcomes:
measure: 63-140 mg/dL Time in Range
timeFrame: at visit 4(gestational age 36weeks)
Secondary outcomes:
measure: AbA1C (%)
timeFrame: at visit 4(gestational age 36weeks)
measure: Glycated Albumin(g/dL)
timeFrame: at visit 4(gestational age 36weeks)
measure: >180 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: >140 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: >120 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: <63mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: <54mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: 63-120mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Overall average blood glucose level
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Overall average Night time Blood glucose (0AM-6AM) level
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Overall average During the day time blood glucose (6AM-12PM) level
timeFrame: 1 week before Visit4 (gestational age 36weeks)
measure: Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)
timeFrame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)
measure: glucose variability
timeFrame: 1 week before Visit4(gestational age 36weeks)
measure: rate of insulin treatment
timeFrame: From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week)
measure: Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit
timeFrame: 1 week before Visit4(Gestational age 36 week)
measure: Total daily insulin requirements (evaluated at every visit)
timeFrame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)
measure: Satisfaction Questionnaire
timeFrame: Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)
measure: C-section rate
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: preeclampsia rate
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: preeclampsia or gestational hypertension rate
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: the rate of preterm birth
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: Weight gain during the study period
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: Average daily blood glucose measurements during the study period
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: Changes in Microbiome
timeFrame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)
measure: Rate of transition to type 2 diabetes
timeFrame: at post partum (6-12 weeks after delivery)
measure: Rate of transition to Glucose intolerance (prediabetes and/or diabetes)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Rate of transition to Impaired fasting glucose (IFG) and/or diabetes
timeFrame: at post partum (6-12 weeks after delivery)
measure: Rate of transition to Impaired fasting glucose (IGT) and/or diabetes
timeFrame: at post partum (6-12 weeks after delivery)
measure: 75g OGTT hourly blood glucose
timeFrame: at post partum (6-12 weeks after delivery)
measure: hemoglobinA1C
timeFrame: at post partum (6-12 weeks after delivery)
measure: glycated albumin
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin resistance index (HOMA-IR)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin resistance index (Matsuda index)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin secretion ability index (HOMA-beta)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin secretion ability index (Insulinogenic index)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin Composite index(Oral disposition index)
timeFrame: at post partum (6-12 weeks after delivery)
measure: Insulin Composite index(disposition index)
timeFrame: at post partum (6-12 weeks after delivery)
measure: weight change
timeFrame: at post partum (6-12 weeks after delivery)
measure: Change in Bioelectric impedance analysis (BIA)
timeFrame: at post partum (6-12 weeks after delivery)
measure: fetal: childbirth weight
timeFrame: at Delivery
measure: fetal: Macrosomia ( > 4000 g)
timeFrame: at Delivery
measure: fetal:Large for gestational age ( > 90th percentile for age)
timeFrame: at Delivery
measure: fetal:Small for gestational age ( < 10th percentile for age)
timeFrame: at Delivery
measure: fetal:Neonatal glucose level
timeFrame: at Delivery
measure: fetal:NICU admission
timeFrame: at Delivery
measure: fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)
timeFrame: at Delivery
measure: fetal:Pre-term birth
timeFrame: at Delivery
measure: fetal:Apgar score
timeFrame: at Delivery
measure: fetal:Meconium aspiration
timeFrame: at Delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung hospital
Study officials:
affiliation: KangbukSamsung Hospital
name: Cheol-Young Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.