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

Gestational Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436326
• Other study ID #: 202311035RINC
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: HUNG-HUI CHEN, PhD
• Phone: 886-2-2394-7109
• Email: hunghuichen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Device:
• Continuous glucose monitor
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.

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

Other:
• Blood glucose meters (BGM)
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maternal glycated albumin	glycated albumin	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Maternal albumin	albumin	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Maternal fasting plasma glucose	fasting plasma glucose	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Maternal insulin	insulin	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Total cholesterol	total cholesterol	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Triglycerides	triglycerides	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	High-density lipoprotein	high-density lipoprotein	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Low-density lipoprotein	low-density lipoprotein	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Primary	Fetal macrosomia	Fetal macrosomia is defined as a birth weight =4,000 g.	4-12 weeks postpartum
Secondary	Gestational weight gain	Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Secondary	Depression	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.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Infant growth curve	infant growth curve	4-12 weeks postpartum
Secondary	Maternal average fasting plasma glucose	average fasting plasma glucose	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Maternal average plasma glucose, Post-cibum	average plasma glucose, Post-cibum	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Postpartum weight retention	the weight change from pre-pregnancy to a period postpartum	4-12 weeks postpartum
Secondary	Insulin medications	dosage and insulin form	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Hypertensive disorders in pregnancy	Number of Participants with preeclampsia-eclampsia or gestational hypertension	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Secondary	Cesarean Section	Number of Participants with Cesarean Section	4-12 weeks postpartum
Secondary	Exercise Frequency	Number of exercises per week.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Health behavior change of glycemic control Scale	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.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Health Belief of glycemic control Scale	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.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Quality of life assessment	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.	24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Secondary	Glucose monitoring satisfaction Scale	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.	33 weeks of pregnancy to before delivery
Secondary	Perceived benefits and barriers of CGM	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.	33 weeks of pregnancy to before delivery