The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes

NCT06436326 | Recruiting FDA Device

• 1 other identifier: 202311035RINC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).

Conditions

Gestational Diabetes Mellitus; Continuous Glucose Monitoring

Keywords

Gestational Diabetes Mellitus; Continuous Glucose Monitoring; Health Interventions

Outcome Measures

Primary Outcomes (10)

• Maternal Oral glucose tolerance test

  Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.

  24-32 weeks of pregnancy, 4-12 weeks postpartum

• Maternal glycated albumin

  glycated albumin

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Maternal albumin

  albumin

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Maternal fasting plasma glucose

  fasting plasma glucose

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Maternal insulin

  insulin

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Total cholesterol

  total cholesterol

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Triglycerides

  triglycerides

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• High-density lipoprotein

  high-density lipoprotein

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Low-density lipoprotein

  low-density lipoprotein

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Fetal macrosomia

  Fetal macrosomia is defined as a birth weight ≥4,000 g.

  4-12 weeks postpartum

Secondary Outcomes (15)

• Gestational weight gain

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

• Depression

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Infant growth curve

  4-12 weeks postpartum

• Maternal average fasting plasma glucose

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

• Maternal average plasma glucose, Post-cibum

  24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum

Study Arms (3)

Controlled group-Blood glucose meters (BGM) group

OTHER

The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.

Other: Blood glucose meters (BGM)

Experimental group1-Continuous glucose monitoring (CGM) group

EXPERIMENTAL

The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".

Device: Continuous glucose monitor

Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

EXPERIMENTAL

The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively. Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)". Participants will receive perinatal nursing care for gestational diabetes.

Device: Continuous glucose monitor; Behavioral: Perinatal nursing care for gestational diabetes

Interventions

Continuous glucose monitor DEVICE

Participants will receive a set of continuous glucose monitor (CGM) at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)," respectively. CGM wearing instruction will be provided before the first wearing at "24-32 weeks of pregnancy". After completing the first wearing (approximately 14 days after starting to wear), the investigators will provide a glucose monitor report. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor report was given approximately 14 days after starting to wear.

Also known as: Abbott FreeStyle Libre 2 (CGM)

Experimental group1-Continuous glucose monitoring (CGM) group; Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

Perinatal nursing care for gestational diabetes BEHAVIORAL

Individual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.

Experimental group2-Continuous glucose monitoring (CGM) with nursing care group

Blood glucose meters (BGM) OTHER

Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.

Controlled group-Blood glucose meters (BGM) group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participants of this study are pregnant women with gestational diabetes mellitus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above
• Pregnant women diagnosed with gestational diabetes mellitus
• Those who are willing to participate in this study

You may not qualify if:

• Those who have been diagnosed with diabetes mellitus "before pregnancy"
• Those whose skin is likely allergic to some materials such as tapes (signs and symptoms such as redness, swelling, itching, painful, presenting blisters or rashes caused by wearing breathable tapes, patches, etc.)
• Those who is with abnormal coagulation function

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, 302058, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• HUNG-HUI CHEN, PhD

  National Taiwan University Hostiptal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUNG-HUI CHEN, PhD

CONTACT

886-2-2394-7109; hunghuichen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 31, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)