Gestational Diabetes MellitusNCT06648174
The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus
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 aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with… 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
- 11 Nov 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
- Willing to participate in the study
Who cannot join
- Diagnosed with diabetes mellitus before pregnancy
- Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
- 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 Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus: The Development and Application of "a Lifestyle Intervention Based on Health Belief Model Supported by Mobile Health"
This study aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).
Read the detailed description
Background: Women with gestational diabetes mellitus (GDM) are more likely to develop cardiometabolic risk (CMR). CMR refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. However, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of GDM from developing CMR has rarely been studied.
Methods: This randomized controlled trial will recruit 120 GDM pregnant women in northern Taiwan. The participants will be randomly assigned to the control group (blood glucose meters (BGM); n=40 people), intervention group 1 (continuous glucose monitoring (CGM); n=40 people), intervention group 2 (HBM-based lifestyle and mHealth intervention + CGM; n=40 people).The comparison group will receive the routine care and finger-prick test for blood glucose monitoring (BGM) during pregnancy.The intervention group 1 will receive CGM during pregnancy. The intervention group 2 will receive a HBM-based lifestyle and mHealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including CGM during pregnancy.We intend to compare outcome variables among three groups. The outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. Outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. Generalized estimating equation (GEE) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.
- 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 7-14 days after starting to wear), the investigators will provide glucose monitor reports. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor reports was given approximately 7-14 days after starting to wear.
Perinatal nursing care for gestational diabetesBehavioural
Individual nursing care and consultation for women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum.
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 7-14 days of glucose monitoring at 24-32 weeks of pregnancy, glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at 33 weeks to before delivery, another glucose monitor reports 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 at 24-32 weeks of pregnancy, 33 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 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports 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 at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants. Receives: Device: Continuous glucose monitor |
| Experimental group2-Continuous glucose monitoring (CGM) with nursing care group | Experimental | The participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants.
Participants will receive nursing care for gestational diabetes at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum. 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.
Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results
This outcome measure assesses the number of participants with abnormal results from the Oral Glucose Tolerance Test (OGTT), which includes measurements of fasting, 1-hour, and 2-hour glucose levels. The data will be summarized based on the thresholds established for abnormal glucose levels, as per standard diagnostic criteria for gestational diabetes.
Measured: 24-32 weeks of pregnancy, 4-12 weeks postpartum
HOMA-IR Value for Assessing Insulin Resistance in Participants
This outcome measure evaluates the HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) value in participants, calculated using fasting insulin and fasting glucose levels. Data will be obtained through reviews of medical records.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Total Cholesterol Levels in Participants
This outcome measure assesses the total cholesterol levels in participants. Data will be obtained through reviews of medical records. The data will be summarized by reporting the mean total cholesterol level, as well as the proportion of participants classified as having high total cholesterol levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Triglycerides Levels in Participants
This outcome measure assesses the triglycerides levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean triglycerides level, as well as the proportion of participants classified as having high triglycerides levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
High-density Lipoprotein Levels in Participants
This outcome measure assesses the high-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean high-density lipoprotein level, as well as the proportion of participants classified as having high high-density lipoprotein levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Low-density Lipoprotein Levels in Participants
This outcome measure assesses the low-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean low-density lipoprotein level, as well as the proportion of participants classified as having high low-density lipoprotein levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Glycated Albumin Levels in Participants
This outcome measure assesses the glycated albumin levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean glycated albumin level, as well as the proportion of participants classified as having high glycated albumin levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Fasting Plasma Glucose Levels in Participants
This outcome measure assesses the fasting plasma glucose levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean fasting plasma glucose level, as well as the proportion of participants classified as having high fasting plasma glucose levels based on established clinical thresholds.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Incidence of Fetal Macrosomia as Measured by Birth Weight
This outcome measure assesses the incidence of fetal macrosomia in participants. Data will be summarized by reporting the proportion of newborns classified as having fetal macrosomia based on the established weight threshold.
Measured: 4-12 weeks postpartum
Secondary outcomes (13)
Incidence of Hypertensive Disorders in Pregnancy
This outcome measure assesses the incidence of hypertensive disorders in pregnancy, including gestational hypertension, preeclampsia, and eclampsia. Data will be summarized by reporting the proportion of participants diagnosed with any hypertensive disorder during pregnancy.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Rate of Cesarean Section Deliveries
This outcome measure assesses the rate of cesarean section deliveries among participants.
Measured: 4-12 weeks postpartum
Health Belief Scale for Glycemic Control
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.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
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 assessed by Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires
The Benefits of Continuous Glucose Monitoring (BenCGM) and Burdens of Continuous Glucose Monitoring (BurCGM) Questionnaires will be used to assess participants' perceived benefits and barriers of using CGM. The data will be summarized as quantitative scores, with higher scores indicating greater perceived benefits or barriers, respectively. Each questionnaire includes multiple items rated on a Likert scale, and the total scores will be aggregated for each participant.
Measured: 33 weeks of pregnancy to before delivery
Gestational Weight Gain as Measured by Weight Change Across Pregnancy Weeks or Total Weight Gain During Pregnancy
This outcome measure assesses gestational weight gain in participants, defined as the weight change between different pregnancy weeks or the total weight gain during pregnancy.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Depression Severity as Measured by the Edinburgh Postnatal Depression Scale (EPDS)
This outcome measure assesses the severity of depression in participants using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item questionnaire. Each item is scored from 0 to 3, resulting in a total score range from 0 to 30. Higher scores indicate a higher likelihood of depression, with scores above 12 or 13 suggesting probable depression.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Infant Growth Curve as Measured by WHO Growth Standards
This outcome measure assesses infant growth curves using the World Health Organization (WHO) growth standards. Data on infant weight, length, and head circumference will be collected at multiple time points. The data will be summarized by reporting the mean values at each time point and the proportion of infants classified as underweight, normal weight, or overweight.
Measured: 4-12 weeks postpartum
Average Postpartum Weight Retention
The postpartum weight retention will be measured as the difference between pre-pregnancy weight and weight at 4-12 weeks postpartum
Measured: 24-32 weeks of pregnancy, 4-12 weeks postpartum
Percentage of Participants on Insulin Medications
This outcome will report the proportion of participants who required insulin medications, expressed as a percentage of the total study population. Insulin use will be tracked through medical records and self-reports.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Average Exercise Frequency
Exercise frequency will be measured based on self-reported exercise sessions per week. The data will be summarized as an average number of sessions per week for the study population at each time point.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 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 and 4-12 weeks postpartum
Assessment of Quality of Life Using the World Health Organization Quality of Life Scale (WHOQOL-BREF) Taiwan Version
This measure assesses quality of life using the WHOQOL-BREF Taiwan version. Data will be aggregated and reported as domain-specific scores and an overall quality of life score, based on participant responses.
Measured: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start11 Nov 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
- NCT06648174
- Sponsor's protocol ID
- 202403080RIND
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2024
- Last updated
- 20 Jan 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Project for Managing Cardiometabolic Risk in Women Diagnosed With Gestational Diabetes Mellitus: The Development and Application of "a Lifestyle Intervention Based on Health Belief Model Supported by Mobile Health"
- ClinicalTrials.gov ID
- NCT06648174
- Acronym / sponsor ID
- 202403080RIND
- 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
- 11 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Oct 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 aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).
Detailed description
Background: Women with gestational diabetes mellitus (GDM) are more likely to develop cardiometabolic risk (CMR). CMR refers to the risk factors that promote the chance of developing type 2 diabetes mellitus or cardiovascular events. However, using a family-centered approach, the effectiveness of continuous administration of both mobile health management and theoretical based lifestyle intervention from pregnancy to postpartum in preventing women at high risk of GDM from developing CMR has rarely been studied.
Methods: This randomized controlled trial will recruit 120 GDM pregnant women in northern Taiwan. The participants will be randomly assigned to the control group (blood glucose meters (BGM); n=40 people), intervention group 1 (continuous glucose monitoring (CGM); n=40 people), intervention group 2 (HBM-based lifestyle and mHealth intervention + CGM; n=40 people).The comparison group will receive the routine care and finger-prick test for blood glucose monitoring (BGM) during pregnancy.The intervention group 1 will receive CGM during pregnancy. The intervention group 2 will receive a HBM-based lifestyle and mHealth management program on 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum, including CGM during pregnancy.We intend to compare outcome variables among three groups. The outcomes variables will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and maternal health behavior. Outcomes will be assessed at baseline (24-32 weeks of pregnancy), 33 weeks of pregnancy to before delivery, 4 to 12 weeks after delivery. Generalized estimating equation (GEE) will be used to examine the trajectories and the effectiveness of the project for managing cardiometabolic risk on cardiometabolic risk and health behavior.
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 at 24-32 weeks of pregnancy, 33 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 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants. |
| Experimental group1-Continuous glucose monitoring (CGM) group | Experimental | Device: Continuous glucose monitorThe participants will receive structured questionnaires at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants. |
| 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 at 24-32 weeks of pregnancy, 33 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)". After 7-14 days of glucose monitoring at "24-32 weeks of pregnancy", glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor reports will be given to the participants. Participants will receive nursing care for gestational diabetes at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum. |
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
- Willing to participate in the study
Key exclusion criteria (3 listed)
- Diagnosed with diabetes mellitus before pregnancy
- Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches)
- 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 7-14 days after starting to wear), the investigators will provide glucose monitor reports. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor reports was given approximately 7-14 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 women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support at 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4-12 weeks postpartum. | 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 7-14 days of glucose monitoring at 24-32 weeks of pregnancy, glucose monitor reports will be given to the participants. After the 7-14 days of glucose monitoring at 33 weeks to before delivery, another glucose monitor reports will be given to the participants. | Other | Controlled group-Blood glucose meters (BGM) group |
Primary outcome
Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results
Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
This outcome measure assesses the number of participants with abnormal results from the Oral Glucose Tolerance Test (OGTT), which includes measurements of fasting, 1-hour, and 2-hour glucose levels. The data will be summarized based on the thresholds established for abnormal glucose levels, as per standard diagnostic criteria for gestational diabetes.
HOMA-IR Value for Assessing Insulin Resistance in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure evaluates the HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) value in participants, calculated using fasting insulin and fasting glucose levels. Data will be obtained through reviews of medical records.
Total Cholesterol Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the total cholesterol levels in participants. Data will be obtained through reviews of medical records. The data will be summarized by reporting the mean total cholesterol level, as well as the proportion of participants classified as having high total cholesterol levels based on established clinical thresholds.
Triglycerides Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the triglycerides levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean triglycerides level, as well as the proportion of participants classified as having high triglycerides levels based on established clinical thresholds.
High-density Lipoprotein Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the high-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean high-density lipoprotein level, as well as the proportion of participants classified as having high high-density lipoprotein levels based on established clinical thresholds.
Low-density Lipoprotein Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the low-density lipoprotein levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean low-density lipoprotein level, as well as the proportion of participants classified as having high low-density lipoprotein levels based on established clinical thresholds.
Glycated Albumin Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the glycated albumin levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean glycated albumin level, as well as the proportion of participants classified as having high glycated albumin levels based on established clinical thresholds.
Fasting Plasma Glucose Levels in Participants
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
This outcome measure assesses the fasting plasma glucose levels in participants. The data obtained through medical record reviews. The data will be summarized by reporting the mean fasting plasma glucose level, as well as the proportion of participants classified as having high fasting plasma glucose levels based on established clinical thresholds.
Incidence of Fetal Macrosomia as Measured by Birth Weight
Time frame: 4-12 weeks postpartum
This outcome measure assesses the incidence of fetal macrosomia in participants. Data will be summarized by reporting the proportion of newborns classified as having fetal macrosomia based on the established weight threshold.
13 secondary outcomes
Incidence of Hypertensive Disorders in Pregnancy
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Rate of Cesarean Section Deliveries
Time frame: 4-12 weeks postpartum
Health Belief Scale for Glycemic Control
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Glucose monitoring satisfaction Scale
Time frame: 33 weeks of pregnancy to before delivery
Perceived benefits and barriers of CGM assessed by Benefits of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires
Time frame: 33 weeks of pregnancy to before delivery
Gestational Weight Gain as Measured by Weight Change Across Pregnancy Weeks or Total Weight Gain During Pregnancy
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
Depression Severity as Measured by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Infant Growth Curve as Measured by WHO Growth Standards
Time frame: 4-12 weeks postpartum
Average Postpartum Weight Retention
Time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum
Percentage of Participants on Insulin Medications
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
Average Exercise Frequency
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 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 and 4-12 weeks postpartum
Assessment of Quality of Life Using the World Health Organization Quality of Life Scale (WHOQOL-BREF) Taiwan Version
Time frame: 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery and 4-12 weeks postpartum
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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 20 Jan 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?
Number of Participants with Abnormal Maternal Oral Glucose Tolerance Test Results (time frame: 24-32 weeks of pregnancy, 4-12 weeks postpartum). The study lists 9 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 20 Jan 2026.