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Gestational Diabetes Mellitus in PregnancyGDMLIBRENCT06031987

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

A study testing CareSens N (iSENS) and Freestyle Libre (Abbott) in people with Gestational Diabetes Mellitus in Pregnancy, run by Kangbuk Samsung Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 19 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
CareSens N (iSENS) and Freestyle Libre (Abbott)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
26 Jan 2022to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

[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
  5. 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

Trial locations and contacts

1 site in 1 country.

Cheol-Young Park, MD contact

82-010-3397-6107

cydoctor68@gmail.com

SunJoon Moon, MD contact

ipleat.m@gmail.com

South Korea1 site, 1 recruiting

  • Kangbuk Samsung hospital

    Seoul

    Cheol-Young Park, MD, 82-010-3397-6107, cydoctor68@gmail.com

    Recruiting

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
CareSens N (iSENS), Freestyle Libre (Abbott)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CareSens N (iSENS)Device

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

  • Freestyle Libre (Abbott)Device

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

Study groups in NCT06031987
Study groupRoleWhat they receive
SMBG armActive comparatorSelf Monitoring of Blood Glucose group
Receives: Device: CareSens N (iSENS)
CGMS armExperimentalContinuous glucose monitoring system, CGM
Receives: Device: Freestyle Libre (Abbott)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 63-140 mg/dL Time in Range

    63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit

    Measured: at visit 4(gestational age 36weeks)

Secondary outcomes (53)

  1. AbA1C (%)

    HbA1C evaluated at visit 4

    Measured: at visit 4(gestational age 36weeks)

  2. Glycated Albumin(g/dL)

    Glycated Albumin evaluated at visit 4

    Measured: at visit 4(gestational age 36weeks)

  3. >180 mg/dL Time in Range

    >180 mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  4. >140 mg/dL Time in Range

    >140 mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  5. >120 mg/dL Time in Range

    >120 mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  6. <63mg/dL Time in Range

    <63mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  7. <54mg/dL Time in Range

    <54mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  8. 63-120mg/dL Time in Range

    63-120mg/dL Time in Range evaluated for 1 week before Visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  9. 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

    Measured: 1 week before Visit4 (gestational age 36weeks)

  10. 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

    Measured: 1 week before Visit4 (gestational age 36weeks)

  11. 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

    Measured: 1 week before Visit4 (gestational age 36weeks)

  12. 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

    Measured: 1 week before Visit4 (gestational age 36weeks)

  13. Overall average blood glucose level

    Overall average blood glucose level evaluated for 1week before visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  14. Overall average Night time Blood glucose (0AM-6AM) level

    Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4

    Measured: 1 week before Visit4 (gestational age 36weeks)

  15. 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

    Measured: 1 week before Visit4 (gestational age 36weeks)

  16. Frequency of severe hypoglycemia(Hypoglycemia requiring help from others)

    Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)

    Measured: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)

  17. glucose variability

    glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)

    Measured: 1 week before Visit4(gestational age 36weeks)

  18. rate of insulin treatment

    rate of insulin treatment

    Measured: From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week)

  19. 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

    Measured: 1 week before Visit4(Gestational age 36 week)

  20. Total daily insulin requirements (evaluated at every visit)

    Total daily insulin requirements (evaluated at every visit)

    Measured: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week)

  21. Satisfaction Questionnaire

    Satisfaction Questionnaire(DTSQ) ,Score: min0 ~max 48, higher scores mean a better outcome

    Measured: Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week)

  22. C-section rate

    C-section rate

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  23. preeclampsia rate

    preeclampsia rate

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  24. preeclampsia or gestational hypertension rate

    preeclampsia or gestational hypertension rate

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  25. the rate of preterm birth

    the rate of preterm birth

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  26. Weight gain during the study period

    Weight gain during the study period

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  27. Average daily blood glucose measurements during the study period

    Freestyle Libre scans, SMBG

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  28. Changes in Microbiome

    Changes in Microbiome

    Measured: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks)

  29. Rate of transition to type 2 diabetes

    Rate of transition to type 2 diabetes

    Measured: at post partum (6-12 weeks after delivery)

  30. Rate of transition to Glucose intolerance (prediabetes and/or diabetes)

    Rate of transition to Glucose intolerance (prediabetes and/or diabetes)

    Measured: at post partum (6-12 weeks after delivery)

  31. Rate of transition to Impaired fasting glucose (IFG) and/or diabetes

    Rate of transition to Impaired fasting glucose (IFG) and/or diabetes

    Measured: at post partum (6-12 weeks after delivery)

  32. Rate of transition to Impaired fasting glucose (IGT) and/or diabetes

    Rate of transition to Impaired fasting glucose (IGT) and/or diabetes

    Measured: at post partum (6-12 weeks after delivery)

  33. 75g OGTT hourly blood glucose

    75g OGTT hourly blood glucose

    Measured: at post partum (6-12 weeks after delivery)

  34. hemoglobinA1C

    hemoglobinA1C

    Measured: at post partum (6-12 weeks after delivery)

  35. glycated albumin

    glycated albumin

    Measured: at post partum (6-12 weeks after delivery)

  36. Insulin resistance index (HOMA-IR)

    HOMA-IR (no unit, higher score means a worse outcome)

    Measured: at post partum (6-12 weeks after delivery)

  37. Insulin resistance index (Matsuda index)

    Matsuda index (no unit, higher score means a better outcome)

    Measured: at post partum (6-12 weeks after delivery)

  38. Insulin secretion ability index (HOMA-beta)

    HOMA-beta(no unit, higher score means a better outcome)

    Measured: at post partum (6-12 weeks after delivery)

  39. Insulin secretion ability index (Insulinogenic index)

    Insulinogenic index(no unit, higher score means a better outcome)

    Measured: at post partum (6-12 weeks after delivery)

  40. Insulin Composite index(Oral disposition index)

    Oral disposition index(no unit, higher score means a better outcome)

    Measured: at post partum (6-12 weeks after delivery)

  41. Insulin Composite index(disposition index)

    disposition index(no unit, higher score means a better outcome)

    Measured: at post partum (6-12 weeks after delivery)

  42. weight change

    weight change

    Measured: at post partum (6-12 weeks after delivery)

  43. Change in Bioelectric impedance analysis (BIA)

    Change in Bioelectric impedance analysis (BIA)

    Measured: at post partum (6-12 weeks after delivery)

  44. fetal: childbirth weight

    fetal: childbirth weight

    Measured: at Delivery

  45. fetal: Macrosomia ( > 4000 g)

    fetal: Macrosomia ( > 4000 g)

    Measured: at Delivery

  46. fetal:Large for gestational age ( > 90th percentile for age)

    fetal:Large for gestational age ( > 90th percentile for age)

    Measured: at Delivery

  47. fetal:Small for gestational age ( < 10th percentile for age)

    fetal:Small for gestational age ( < 10th percentile for age)

    Measured: at Delivery

  48. fetal:Neonatal glucose level

    fetal:Neonatal glucose level

    Measured: at Delivery

  49. fetal:NICU admission

    fetal:NICU admission

    Measured: at Delivery

  50. fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)

    fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)

    Measured: at Delivery

  51. fetal:Pre-term birth

    fetal:Pre-term birth

    Measured: at Delivery

  52. fetal:Apgar score

    score: min 0 ~ max 10, higher scores mean a better outcome

    Measured: at Delivery

  53. fetal:Meconium aspiration

    fetal:Meconium aspiration

    Measured: at Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start26 Jan 2022
  3. Primary completion26 Jan 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, parallel, open labeled study
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06031987
Sponsor's protocol ID
GDMLIBRE
Acronym
GDMLIBRE
Status last verified
Sep 2023
First submitted
21 Oct 2022
Last updated
11 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

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.

    PubMed 26940115

  • 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.

    PubMed 24300020

  • 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.

    PubMed 30396252

  • 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.

    PubMed 27046149

  • 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.

    PubMed 24945238

  • 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.

    PubMed 31296866

Questions about this trial

What is this clinical trial studying?

A study testing CareSens N (iSENS) and Freestyle Libre (Abbott) in people with Gestational Diabetes Mellitus in Pregnancy, run by Kangbuk Samsung Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cheol-Young Park, MD (82-010-3397-6107, cydoctor68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

63-140 mg/dL Time in Range (time frame: at visit 4(gestational age 36weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06031987, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.

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