Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06436326

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gestational Diabetes Mellitus Continuous Glucose Monitoring Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital

Hsinchu, 302058, Taiwan

Location status: Recruiting

Location contact

HUNG-HUI CHEN

CONTACT

[email protected]

+886-2-23947109

About this study

Background: The global prevalence of gestational diabetes mellitus is increasing. To reduce the negative impact of gestational diabetes mellitus on maternal and fetal health, managing blood glucose during pregnancy is important, which also shows the importance of blood glucose monitoring. Continuous glucose monitoring (CGM) is different from traditional blood glucose meters (BGM). Continuous glucose monitoring is now known to have good control effects in type 1 and type 2 diabetes mellitus. However, there are still few randomized controlled trials for gestational diabetes mellitus and there are not consistent results. In addition, blood glucose management conditions vary among groups with different dietary habits, socioeconomic status and income. Food culture of Taiwan is diverse and it is easy to consume sugar or high carbohydrate foods. Continuous glucose monitoring can be more sensitive to measure glucose fluctuations, but it is still unknown whether it will have different maternal and infant health effects for groups whose glucose is prone to exceed the target range.

Objective: To explore the impact of continuous glucose monitoring on the health outcomes of mothers and infants with gestational diabetes mellitus, and to test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income) on the relationship between continuous glucose monitoring and the health outcomes among mothers with gestational diabetes mellitus and their infants.

Methods: This study was a randomized controlled trial. It was expected that 120 pregnant women with gestational diabetes mellitus would be randomly assigned to the " Control group" (40 people) using blood glucose meters (BGM), or the "experimental group" (80 people) using continuous glucose monitoring (CGM) at a ratio of 1:2. In the "experimental group", they would be assigned to the " Experimental group1-Continuous glucose monitoring (CGM) group" (40 people) or the " Experimental group2-Continuous glucose monitoring (CGM) with nursing care group" (40 people). The " Experimental group2-Continuous glucose monitoring (CGM) with nursing care group " would provide nursing intervention during the perinatal period. The outcome variables of the three groups would be tracked and compared with 3 time points, which were 24 to 32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and fetal macrosomia. Secondary outcomes included gestational weight, depression and infant growth curve.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Abbott FreeStyle Libre 2 (CGM)

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.

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.

Primary outcomes

  1. Maternal Oral glucose tolerance test

    Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum

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

  2. Maternal glycated albumin

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

    glycated albumin

  3. Maternal albumin

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

    albumin

  4. Maternal fasting plasma glucose

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

    fasting plasma glucose

  5. Maternal insulin

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

    insulin

  6. Total cholesterol

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

    total cholesterol

  7. Triglycerides

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

    triglycerides

  8. High-density lipoprotein

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

    high-density lipoprotein

  9. Low-density lipoprotein

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

    low-density lipoprotein

  10. Fetal macrosomia

    Time frame: 4-12 weeks postpartum

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

Secondary outcomes

  1. Gestational weight gain

    Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

    Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.

  2. Depression

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

    Edinburgh Postnatal Depression Scale (EPDS) The EPDS is a 10-item questionnaire. Each item scores from 0-3. The total score is found by adding together the scores for each of the 10 items. The minimum is 0 and the maximum is 30. Scoring above 12 or 13 are likely to be suffering from depression.

  3. Infant growth curve

    Time frame: 4-12 weeks postpartum

    infant growth curve

  4. Maternal average fasting plasma glucose

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

    average fasting plasma glucose

  5. Maternal average plasma glucose, Post-cibum

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

    average plasma glucose, Post-cibum

  6. Postpartum weight retention

    Time frame: 4-12 weeks postpartum

    the weight change from pre-pregnancy to a period postpartum

  7. Insulin medications

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

    dosage and insulin form

  8. Hypertensive disorders in pregnancy

    Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery

    Number of Participants with preeclampsia-eclampsia or gestational hypertension

  9. Cesarean Section

    Time frame: 4-12 weeks postpartum

    Number of Participants with Cesarean Section

  10. Exercise Frequency

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

    Number of exercises per week.

  11. Health behavior change of glycemic control Scale

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

    A 3-item Likert scale based on the Transtheoretical model, including self-monitoring of glucose level, diet and physical activity. Each item scores from 0-4. A higher score means closer to the action or maintenance stage.

  12. Health Belief of glycemic control Scale

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

    A 21-item Likert scale based on the Health Belief model includes 5 categories: perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy.

    Each item scores from 0-4. A higher score means higher the individual's beliefs about preventing diseases or maintaining health in perceived susceptibility, perceived severity, perceived benefits and self-efficacy categories. A higher score means higher the individual's barriers to preventing diseases or maintaining health in the perceived barriers category.

  13. Quality of life assessment

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

    World Health Organization Quality-of-Life Scale:BREF Taiwan Version The scale evaluates four domains of quality of life ("Physical Health," "Psychological Health," "Social Relationships," and "Environment"), and contains four other questions :overall perception of quality of life, general health, dietary ,feel respected. Every domain scores from 4-20. Higher scores mean a better quality of life.

  14. Glucose monitoring satisfaction Scale

    Time frame: 33 weeks of pregnancy to before delivery

    Satisfaction of using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale. A 4-item Likert scale includes 4 categories: ease of use, painful, convenience and overall satisfaction. Each item scores from 1-5. A higher score means lower satisfaction.

  15. Perceived benefits and barriers of CGM

    Time frame: 33 weeks of pregnancy to before delivery

    Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires. A 16-item Likert scale includes 2 categories: benefits of CGM and burdens of CGM. Each item scores from 1-5. A higher score means a higher benefit in benefit of CGM category. A higher score means higher burdens in burdens of CGM category.

Study contacts

Contact information is provided by the study sponsor or research team.

HUNG-HUI CHEN, PhD

CONTACT

[email protected]

886-2-2394-7109

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes: Testing the Moderating Effects of Socioeconomic and Cultural Factors

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 31, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.