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

• ClinicalTrials.gov Identifier: NCT06031987
• Recruitment Status: Recruiting
• First Posted: September 11, 2023
• Last Update Posted: September 11, 2023
• Sponsor: Kangbuk Samsung Hospital
• Collaborator: Daewoong Pharmaceutical Co. LTD.
• Information provided by (Responsible Party): Cheol-Young Park, Kangbuk Samsung Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes Mellitus in Pregnancy	Device: CareSens N (iSENS); Device: Freestyle Libre (Abbott)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, parallel, open labeled study
• Masking: None (Open Label)
• Masking Description: Open label
• Primary Purpose: Supportive Care
• Official Title: Long-term Effects of Flash Glucose Monitoring System in Patients With Gestational Diabetes
• Actual Study Start Date: January 26, 2022
• Estimated Primary Completion Date: January 26, 2024
• Estimated Study Completion Date: December 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: SMBG arm; Self Monitoring of Blood Glucose group	Device: CareSens N (iSENS); Control group is asked to perform SMBG (4 times or more per day).
Experimental: CGMS arm; Continuous glucose monitoring system, CGM	Device: Freestyle Libre (Abbott); CGM group is asked to scan CGM (4 times or more per day).

Outcome Measures

Primary Outcome Measures :

1. 63-140 mg/dL Time in Range [ Time Frame: at visit 4(gestational age 36weeks) ]
   63-140 mg/dL Time in Range evaluated for 1 week before Visit4 visit

Secondary Outcome Measures :

1. AbA1C (%) [ Time Frame: at visit 4(gestational age 36weeks) ]
   HbA1C evaluated at visit 4
2. Glycated Albumin(g/dL) [ Time Frame: at visit 4(gestational age 36weeks) ]
   Glycated Albumin evaluated at visit 4
3. >180 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   >180 mg/dL Time in Range evaluated for 1 week before Visit4
4. >140 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   >140 mg/dL Time in Range evaluated for 1 week before Visit4
5. >120 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   >120 mg/dL Time in Range evaluated for 1 week before Visit4
6. <63mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   <63mg/dL Time in Range evaluated for 1 week before Visit4
7. <54mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   <54mg/dL Time in Range evaluated for 1 week before Visit4
8. 63-120mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   63-120mg/dL Time in Range evaluated for 1 week before Visit4
9. Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
   Night time Blood glucose (0AM-6AM) 63-94 mg/dL Time in Range evaluated for 1 week before Visit4
10. Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Night time Blood glucose (0AM-6AM) ≥95 mg/dL Time in Range evaluated for 1 week before Visit4
11. Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Night time Blood glucose (0AM-6AM) <63 mg/dL Time in Range evaluated for 1 week before Visit4
12. Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Night time Blood glucose (0AM-6AM) <54 mg/dL Time in Range evaluated for 1 week before Visit4
13. Overall average blood glucose level [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Overall average blood glucose level evaluated for 1week before visit4
14. Overall average Night time Blood glucose (0AM-6AM) level [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Overall average Night time Blood glucose (0AM-6AM) level evaluated for 1week before visit4
15. Overall average During the day time blood glucose (6AM-12PM) level [ Time Frame: 1 week before Visit4 (gestational age 36weeks) ]
    Overall average During the day time blood glucose (6AM-12PM) level evaluated for 1week before visit4
16. Frequency of severe hypoglycemia(Hypoglycemia requiring help from others) [ Time Frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week) ]
    Frequency of severe hypoglycemia during the study period hyperglycemia requiring help from others)
17. glucose variability [ Time Frame: 1 week before Visit4(gestational age 36weeks) ]
    glucose variability evaluated for 1week before visit4 (MAGE,SD,CV)
18. rate of insulin treatment [ Time Frame: From visit 1 to visit 4 (Gestational age 25-31 weeks to Gestational age 36 week) ]
    rate of insulin treatment
19. Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit [ Time Frame: 1 week before Visit4(Gestational age 36 week) ]
    Estimation A1c of continuous blood glucose measurement for 1 week before Visit4 visit
20. Total daily insulin requirements (evaluated at every visit) [ Time Frame: From visit 1 to visit 4(Gestational age 25-31 weeks to Gestational age 36 week) ]
    Total daily insulin requirements (evaluated at every visit)
21. Satisfaction Questionnaire [ Time Frame: Visit 1 (Gestational age 25-31 weeks) , Visit 4 (Gestational age 36 week) ]
    Satisfaction Questionnaire(DTSQ) ,Score: min0 ~max 48, higher scores mean a better outcome
22. C-section rate [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    C-section rate
23. preeclampsia rate [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    preeclampsia rate
24. preeclampsia or gestational hypertension rate [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    preeclampsia or gestational hypertension rate
25. the rate of preterm birth [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    the rate of preterm birth
26. Weight gain during the study period [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    Weight gain during the study period
27. Average daily blood glucose measurements during the study period [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    Freestyle Libre scans, SMBG
28. Changes in Microbiome [ Time Frame: during the study period (Gestational age 25-31 weeks to Pospartum 6-12 weeks) ]
    Changes in Microbiome
29. Rate of transition to type 2 diabetes [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Rate of transition to type 2 diabetes
30. Rate of transition to Glucose intolerance (prediabetes and/or diabetes) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Rate of transition to Glucose intolerance (prediabetes and/or diabetes)
31. Rate of transition to Impaired fasting glucose (IFG) and/or diabetes [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Rate of transition to Impaired fasting glucose (IFG) and/or diabetes
32. Rate of transition to Impaired fasting glucose (IGT) and/or diabetes [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Rate of transition to Impaired fasting glucose (IGT) and/or diabetes
33. 75g OGTT hourly blood glucose [ Time Frame: at post partum (6-12 weeks after delivery) ]
    75g OGTT hourly blood glucose
34. hemoglobinA1C [ Time Frame: at post partum (6-12 weeks after delivery) ]
    hemoglobinA1C
35. glycated albumin [ Time Frame: at post partum (6-12 weeks after delivery) ]
    glycated albumin
36. Insulin resistance index (HOMA-IR) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    HOMA-IR (no unit, higher score means a worse outcome)
37. Insulin resistance index (Matsuda index) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Matsuda index (no unit, higher score means a better outcome)
38. Insulin secretion ability index (HOMA-beta) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    HOMA-beta(no unit, higher score means a better outcome)
39. Insulin secretion ability index (Insulinogenic index) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Insulinogenic index(no unit, higher score means a better outcome)
40. Insulin Composite index(Oral disposition index) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Oral disposition index(no unit, higher score means a better outcome)
41. Insulin Composite index(disposition index) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    disposition index(no unit, higher score means a better outcome)
42. weight change [ Time Frame: at post partum (6-12 weeks after delivery) ]
    weight change
43. Change in Bioelectric impedance analysis (BIA) [ Time Frame: at post partum (6-12 weeks after delivery) ]
    Change in Bioelectric impedance analysis (BIA)
44. fetal: childbirth weight [ Time Frame: at Delivery ]
    fetal: childbirth weight
45. fetal: Macrosomia ( > 4000 g) [ Time Frame: at Delivery ]
    fetal: Macrosomia ( > 4000 g)
46. fetal:Large for gestational age ( > 90th percentile for age) [ Time Frame: at Delivery ]
    fetal:Large for gestational age ( > 90th percentile for age)
47. fetal:Small for gestational age ( < 10th percentile for age) [ Time Frame: at Delivery ]
    fetal:Small for gestational age ( < 10th percentile for age)
48. fetal:Neonatal glucose level [ Time Frame: at Delivery ]
    fetal:Neonatal glucose level
49. fetal:NICU admission [ Time Frame: at Delivery ]
    fetal:NICU admission
50. fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy) [ Time Frame: at Delivery ]
    fetal:birth trauma (including shoulderdystocia, clavicle fracture or Erb's palsy)
51. fetal:Pre-term birth [ Time Frame: at Delivery ]
    fetal:Pre-term birth
52. fetal:Apgar score [ Time Frame: at Delivery ]
    score: min 0 ~ max 10, higher scores mean a better outcome
53. fetal:Meconium aspiration [ Time Frame: at Delivery ]
    fetal:Meconium aspiration

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Gestational Diabetes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

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

Contact: SunJoon Moon, MD; ipleat.m@gmail.com

Locations

Korea, Republic of

Kangbuk Samsung hospital; Recruiting

Seoul, Korea, Republic of

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

Sponsors and Collaborators

Kangbuk Samsung Hospital

Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Cheol-Young Park, MD; KangbukSamsung Hospital

More Information

Additional Information:

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]. 

Publications of Results:

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. Erratum In: PLoS One. 2016 Oct 20;11(10 ):e0165445.

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.

• Responsible Party: Cheol-Young Park, Professor, Kangbuk Samsung Hospital
• ClinicalTrials.gov Identifier: NCT06031987
• Other Study ID Numbers: GDMLIBRE
• First Posted: September 11, 2023
• Last Update Posted: September 11, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases