Gestational Diabetes MellitusNCT06436326
The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes
A study testing Continuous glucose monitor, Perinatal nursing care for gestational diabetes and Blood glucose meters (BGM) in people with Gestational Diabetes Mellitus and Continuous Glucose Monitoring, run by National Taiwan University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Continuous Glucose Monitoring
- What is being tested?
- Continuous glucose monitor, Perinatal nursing care for gestational diabetes and Blood glucose meters (BGM)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above
- Pregnant women diagnosed with gestational diabetes mellitus
- Those who are willing to participate in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
Hsinchu, 302058
HUNG-HUI CHEN, +886-2-23947109, hunghuichen@ntu.edu.tw
About this study
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
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).
Read the detailed 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.
- Being tested
- Continuous glucose monitor, Perinatal nursing care for gestational diabetes, Blood glucose meters (BGM)
- Keywords
- Gestational Diabetes Mellitus, Continuous Glucose Monitoring, Health Interventions
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Also called Abbott FreeStyle Libre 2 (CGM)
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.
Perinatal nursing care for gestational diabetesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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)". Receives: 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. Receives: Device: Continuous glucose monitor; Behavioral: Perinatal nursing care for gestational diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Oral glucose tolerance test
Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
Measured: 24-32 weeks of pregnancy, 4-12 weeks postpartum
Maternal glycated albumin
glycated albumin
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal albumin
albumin
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal fasting plasma glucose
fasting plasma glucose
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal insulin
insulin
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Total cholesterol
total cholesterol
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Triglycerides
triglycerides
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
High-density lipoprotein
high-density lipoprotein
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Low-density lipoprotein
low-density lipoprotein
Measured: 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.
Measured: 4-12 weeks postpartum
Secondary outcomes (15)
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Infant growth curve
infant growth curve
Measured: 4-12 weeks postpartum
Maternal average fasting plasma glucose
average fasting plasma glucose
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal average plasma glucose, Post-cibum
average plasma glucose, Post-cibum
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Postpartum weight retention
the weight change from pre-pregnancy to a period postpartum
Measured: 4-12 weeks postpartum
Insulin medications
dosage and insulin form
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Hypertensive disorders in pregnancy
Number of Participants with preeclampsia-eclampsia or gestational hypertension
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Cesarean Section
Number of Participants with Cesarean Section
Measured: 4-12 weeks postpartum
Exercise Frequency
Number of exercises per week.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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.
Measured: 33 weeks of pregnancy to before delivery
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.
Measured: 33 weeks of pregnancy to before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start22 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUNG-HUI CHEN, PhD, Principal investigator, National Taiwan University Hostiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436326
- Sponsor's protocol ID
- 202311035RINC
- Status last verified
- Jun 2026
- First submitted
- 22 May 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06436326
- Acronym / sponsor ID
- 202311035RINC
- Keywords
- Gestational Diabetes Mellitus, Continuous Glucose Monitoring, Health Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled group-Blood glucose meters (BGM) group | Other | Other: Blood glucose meters (BGM)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. |
| Experimental group1-Continuous glucose monitoring (CGM) group | Experimental | Device: Continuous glucose monitorThe 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)". |
| Experimental group2-Continuous glucose monitoring (CGM) with nursing care group | Experimental | Device: Continuous glucose monitor, Behavioral: Perinatal nursing care for gestational diabetesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or above
- Pregnant women diagnosed with gestational diabetes mellitus
- Those who are willing to participate in this study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorAlso: Abbott FreeStyle Libre 2 (CGM)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. | Device | Experimental group1-Continuous glucose monitoring (CGM) group, Experimental group2-Continuous glucose monitoring (CGM) with nursing care group |
| Perinatal nursing care for gestational diabetesIndividual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support. | Behavioural | Experimental group2-Continuous glucose monitoring (CGM) with nursing care group |
| 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. | Other | Controlled group-Blood glucose meters (BGM) group |
Primary outcome
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.
Maternal glycated albumin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
glycated albumin
Maternal albumin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
albumin
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
Maternal insulin
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
insulin
Total cholesterol
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
total cholesterol
Triglycerides
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
triglycerides
High-density lipoprotein
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
high-density lipoprotein
Low-density lipoprotein
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
low-density lipoprotein
Fetal macrosomia
Time frame: 4-12 weeks postpartum
Fetal macrosomia is defined as a birth weight ≥4,000 g.
15 secondary outcomes
Gestational weight gain
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Depression
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Infant growth curve
Time frame: 4-12 weeks postpartum
Maternal average fasting plasma glucose
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Maternal average plasma glucose, Post-cibum
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Postpartum weight retention
Time frame: 4-12 weeks postpartum
Insulin medications
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Hypertensive disorders in pregnancy
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Cesarean Section
Time frame: 4-12 weeks postpartum
Exercise Frequency
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
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
Health Belief of glycemic control Scale
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Quality of life assessment
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
Glucose monitoring satisfaction Scale
Time frame: 33 weeks of pregnancy to before delivery
Perceived benefits and barriers of CGM
Time frame: 33 weeks of pregnancy to before delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HUNG-HUI CHEN, PhD principal investigator
National Taiwan University Hostiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitor, Perinatal nursing care for gestational diabetes and Blood glucose meters (BGM) in people with Gestational Diabetes Mellitus and Continuous Glucose Monitoring, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUNG-HUI CHEN, PhD (886-2-2394-7109, hunghuichen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Oral glucose tolerance test (time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.