GDMNCT07263412
Gestational Lifestyle & Outcomes Wellness
An observational study of GDM, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- GDM
- What is being tested?
- cgm and Behavioral Self-Monitoring of Blood Glucose
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to Nov 2028
- Phase
- Observational
- 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 to 40 years
- Women only
- Adult
Study population: A total of 1,000 pregnant women with antenatal care registration in the study hospital are enrolled, including 500 Gestational Diabetes Mellitus (GDM) cases (diagnosed via 75g OGTT at 24-28 weeks of gestation with ≥1 abnormal blood glucose value) and 500 normal controls. All participants meet: aged 18-40 years, pre-pregnancy BMI 18.5-28 kg/m², ability to sign informed consent, and prenatal care/delivery in the hospital. Those with multiple pregnancies, pre-gestational diabetes, poorly controlled hypertension, severe organ diseases, or poor compliance are excluded. Participants and their offspring complete perinatal and 2-year postnatal follow-ups.
Who may be able to join
- Aged 18-40 years;
- Pre-pregnancy BMI: 18.5 kg/m² < BMI < 28 kg/m²;
- Able to read, understand and sign the informed consent form;
- Receive prenatal care and deliver in the study hospital.
Who cannot join
- Twin or multiple pregnancies;
- Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
- Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
- Complicated with severe liver/kidney diseases;
- Current/recent use of drugs affecting glucose metabolism;
- Mental illness or severe psychological disorders;
- Complicated with severe infection;
- Poor compliance or refusal to use CGM/SMBG.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu women and children health hospital
Nanjing
Wu, +8618155394955, 2543481029@stu.njmu.edu.cn
2543481029@stu.njmu.edu.cn
About this study
Official title: A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
- Conditions
- GDM
- Being tested
- cgm, Behavioral Self-Monitoring of Blood Glucose, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cgmDevice
Participants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care.
Behavioral Self-Monitoring of Blood GlucoseBehavioural
Participants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care.
ControlOther
Participants will receive standard prenatal care without additional glucose monitoring interventions
| Study group | Role | What they receive |
|---|---|---|
| CGM group | Not described Receives: Device: cgm | |
| SMBG group | Not described Receives: Behavioral: Behavioral Self-Monitoring of Blood Glucose | |
| Control group | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement Rate of Glucose Metabolism During the Perinatal Period
Measured: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.
Secondary outcomes (6)
Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention
Measured: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum
Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)
Measured: From 6 months postpartum to 2 years postpartum
Incidence of Adverse Outcomes
Measured: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum
Long-term Incidence of Cardiovascular Disease (CVD)
Measured: From 6 months postpartum to 2 years postpartum
Abnormal Blood Glucose Status in Offspring
Measured: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)
Obesity Rate in Offspring
Measured: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start25 Feb 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263412
- Sponsor's protocol ID
- GLOW-GDM-COHORT-2024
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
- ClinicalTrials.gov ID
- NCT07263412
- Acronym / sponsor ID
- GLOW-GDM-COHORT-2024
- Conditions
- GDM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 4 Dec 2025 (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.
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CGM group | – | Device: cgm |
| SMBG group | – | Behavioral: Behavioral Self-Monitoring of Blood Glucose |
| Control group | – | Other: Control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- A total of 1,000 pregnant women with antenatal care registration in the study hospital are enrolled, including 500 Gestational Diabetes Mellitus (GDM) cases (diagnosed via 75g OGTT at 24-28 weeks of gestation with ≥1 abnormal blood glucose value) and 500 normal controls. All participants meet: aged 18-40 years, pre-pregnancy BMI 18.5-28 kg/m², ability to sign informed consent, and prenatal care/delivery in the hospital. Those with multiple pregnancies, pre-gestational diabetes, poorly controlled hypertension, severe organ diseases, or poor compliance are excluded. Participants and their offspring complete perinatal and 2-year postnatal follow-ups.
Key inclusion criteria (4 listed)
- Aged 18-40 years;
- Pre-pregnancy BMI: 18.5 kg/m² < BMI < 28 kg/m²;
- Able to read, understand and sign the informed consent form;
- Receive prenatal care and deliver in the study hospital.
Key exclusion criteria (8 listed)
- Twin or multiple pregnancies;
- Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
- Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
- Complicated with severe liver/kidney diseases;
- Current/recent use of drugs affecting glucose metabolism;
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 |
|---|---|---|
| cgmParticipants will wear a continuous glucose monitoring device to continuously record glucose levels throughout the study period, in addition to receiving standard prenatal care. | Device | CGM group |
| Behavioral Self-Monitoring of Blood GlucoseParticipants will perform regular self-monitoring of blood glucose using a finger-prick glucose meter, along with standard prenatal care. | Behavioural | SMBG group |
| ControlParticipants will receive standard prenatal care without additional glucose monitoring interventions | Other | Control group |
Primary outcome
Improvement Rate of Glucose Metabolism During the Perinatal Period
Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.
6 secondary outcomes
Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention
Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum
Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)
Time frame: From 6 months postpartum to 2 years postpartum
Incidence of Adverse Outcomes
Time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum
Long-term Incidence of Cardiovascular Disease (CVD)
Time frame: From 6 months postpartum to 2 years postpartum
Abnormal Blood Glucose Status in Offspring
Time frame: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)
Obesity Rate in Offspring
Time frame: From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth)
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 4 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GDM, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 4 inclusion and 8 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 4 Dec 2025. 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 China. 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 Wu (8618155394955, 2543481029@stu.njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement Rate of Glucose Metabolism During the Perinatal Period (time frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.). 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 4 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.