Gestational Diabetes Mellitus in PregnancyNCT05003154
Digitalized Management Exploration for Gestational Diabetes Mellitus in China
A study testing Digitalized management in people with Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Gestational diabetes mellitus (GDM) can lead to adverse perinatal and long-term outcomes, and it is so important to manage this disease in pregnancy. Digitalized managements have been proved economical and effective in some chronic diseases like type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Digitalized management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The age of 18-45 years, single pregnancy, Han nationality;
- GDM diagnosed between 24 to 28 weeks of gestation, either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
- Plan to deliver the baby in Women's Hospital School Of Medicine Zhejiang University;
- Can operate mobile phones and related software;
- Voluntary participation in this study;
- Education background: junior high school or above.
Who cannot join
- Type I or II or other non GDM diabetes mellitus;
- Severe pregnancy complications or complications: such as malignant tumor, preeclampsia, severe intrahepatic cholestasis of pregnancy syndrome, pregnancy with antiphospholipid antibody syndrome, severe anemia (hemoglobin<90g/L, etc.), cardiac insufficiency cardiovascular disease (such as myocardial infarction, heart failure, pulmonary hypertension, stroke history, coronary heart disease, valvular heart disease, etc.), stroke (moderate), liver disease (such as hepatic insufficiency, acute viral hepatitis, etc.), lung disease (such as restrictive lung disease, emphysema, liver cirrhosis, pulmonary heart disease, etc.), kidney disease (such as nephrotic syndrome, chronic nephritis, renal insufficiency, etc.), chronic hypertension, thyroid disease (such as hyperthyroidism, hypothyroidism, thyroiditis, etc.), other endocrine diseases (such as Cushing's syndrome Acromegaly, venous or arterial thromboembolic diseases, rheumatic immune diseases, etc;
- The combined conditions that may affect the diet exercise therapy include severe food allergy, dyskinesia (physical disability), history of bariatric surgery, major gastrointestinal diseases (such as gastrointestinal bleeding, inflammatory bowel disease, gastrointestinal tumor, active stage of peptic ulcer, chronic intestinal obstruction, etc.), restrictive lung disease, history of two or more adverse abortions, placenta previa, repeated and persistent bleeding threatened abortion, threatened premature birth, hyperemesis gravidarum, vegetarians, etc;
- Other conditions: such as mental disorders, cervical incompetence, genital tract deformity, etc;
- Patients who are taking medicine that may affect glucose metabolism, such as ritodrine, prednisone, etc;
- Patients who are participating in other clinical studies;
- The researchers believe patients who are not suitable for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conventional Mode and Combined Digitalized Mode of Management for Gestational Diabetes Mellitus in China
Gestational diabetes mellitus (GDM) can lead to adverse perinatal and long-term outcomes, and it is so important to manage this disease in pregnancy. Digitalized managements have been proved economical and effective in some chronic diseases like type II diabetes mellitus. The purpose of the current study was to develop and evaluate a digitalized mode for GDM management using mobile healthcare and some wearable devices. Subjects were randomly divided into a conventional management group and combined digitalized management group after diagnosed with GDM during 24-28 weeks of gestation. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received digitalized healthcare services from artificial intelligence under the supervision of obstetricians, in addition to conventional management. The effectiveness of digitalized management were evaluated mainly through the result values of the labotatory tests related to blood glucose controlling and perinatal outcomes.
- Being tested
- Digitalized management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitalized managementOther
In addition to conventional management, Patients also receive digitalized management, which provides personalized guidance in diet, excercise, prenatal visit, blood glucose monitoring,etc., from artificail intelliegence (AI) supevised by obstetricians, through a smartphone application and some werable devices (like sports bracelet).
The pivotal AI are based on clinical experience from obstetricians, therapeutic principle from official Guidelines and abundant data in previous work, and it will works under strict supervision.
| Study group | Role | What they receive |
|---|---|---|
| Conventional management group | No intervention | Received conventional management based on Guidelines for GDM in China |
| Digitalized management group | Experimental | Reveived conventional management and digitalized management Receives: Other: Digitalized management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of glycosylated hemoglobin A1c
Reflecting the average glucose level in the last 8-12 weeks
Measured: 37-42 weeks of gestation
Secondary outcomes (4)
Rate of neonate large for gestational age
May reflecting maternal glucose level in pregnancy
Measured: At the 1 day of delivery
rate of caesarean as the delivery mode
An indicator associated with fetal weight or perinatal condition
Measured: At the 1 day of delivery
Hospitalization cost of neonate and puerperae for delivery
A health economic indicator
Measured: At the 1 day discharging from hospital
Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test
Reflecting postpartum glucose metabolism
Measured: 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Jianhai Technology Company Limited, Quzhou Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003154
- Sponsor's protocol ID
- GDMDM2021
- Status last verified
- Jul 2021
- First submitted
- 30 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Du M, Yi S, Wei Y, Jiang Y, Bao S, Lu J, Chen D. Effect of FSL-CGM on Maternal and Neonatal Outcomes in GDM: A Propensity Score Matching Study in Hangzhou, China. Diabetes Ther. 2025 Jul;16(7):1385-1397. doi: 10.1007/s13300-025-01749-0. Epub 2025 May 12.
PubMed 40353986
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Mode and Combined Digitalized Mode of Management for Gestational Diabetes Mellitus in China
- ClinicalTrials.gov ID
- NCT05003154
- Acronym / sponsor ID
- GDMDM2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Jianhai Technology Company Limited, Quzhou Maternity and Child Health Care Hospital
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 12 Aug 2021 (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.
Gestational diabetes mellitus (GDM) can lead to adverse perinatal and long-term outcomes, and it is so important to manage this disease in pregnancy. Digitalized managements have been proved economical and effective in some chronic diseases like type II diabetes mellitus. The purpose of the current study was to develop and evaluate a digitalized mode for GDM management using mobile healthcare and some wearable devices. Subjects were randomly divided into a conventional management group and combined digitalized management group after diagnosed with GDM during 24-28 weeks of gestation. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received digitalized healthcare services from artificial intelligence under the supervision of obstetricians, in addition to conventional management. The effectiveness of digitalized management were evaluated mainly through the result values of the labotatory tests related to blood glucose controlling and perinatal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional management group | No intervention | –Received conventional management based on Guidelines for GDM in China |
| Digitalized management group | Experimental | Other: Digitalized managementReveived conventional management and digitalized management |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The age of 18-45 years, single pregnancy, Han nationality;
- GDM diagnosed between 24 to 28 weeks of gestation, either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
- Plan to deliver the baby in Women's Hospital School Of Medicine Zhejiang University;
- Can operate mobile phones and related software;
- Voluntary participation in this study;
Key exclusion criteria (7 listed)
- Type I or II or other non GDM diabetes mellitus;
- Severe pregnancy complications or complications: such as malignant tumor, preeclampsia, severe intrahepatic cholestasis of pregnancy syndrome, pregnancy with antiphospholipid antibody syndrome, severe anemia (hemoglobin<90g/L, etc.), cardiac insufficiency cardiovascular disease (such as myocardial infarction, heart failure, pulmonary hypertension, stroke history, coronary heart disease, valvular heart disease, etc.), stroke (moderate), liver disease (such as hepatic insufficiency, acute viral hepatitis, etc.), lung disease (such as restrictive lung disease, emphysema, liver cirrhosis, pulmonary heart disease, etc.), kidney disease (such as nephrotic syndrome, chronic nephritis, renal insufficiency, etc.), chronic hypertension, thyroid disease (such as hyperthyroidism, hypothyroidism, thyroiditis, etc.), other endocrine diseases (such as Cushing's syndrome Acromegaly, venous or arterial thromboembolic diseases, rheumatic immune diseases, etc;
- The combined conditions that may affect the diet exercise therapy include severe food allergy, dyskinesia (physical disability), history of bariatric surgery, major gastrointestinal diseases (such as gastrointestinal bleeding, inflammatory bowel disease, gastrointestinal tumor, active stage of peptic ulcer, chronic intestinal obstruction, etc.), restrictive lung disease, history of two or more adverse abortions, placenta previa, repeated and persistent bleeding threatened abortion, threatened premature birth, hyperemesis gravidarum, vegetarians, etc;
- Other conditions: such as mental disorders, cervical incompetence, genital tract deformity, etc;
- Patients who are taking medicine that may affect glucose metabolism, such as ritodrine, prednisone, etc;
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 |
|---|---|---|
| Digitalized managementIn addition to conventional management, Patients also receive digitalized management, which provides personalized guidance in diet, excercise, prenatal visit, blood glucose monitoring,etc., from artificail intelliegence (AI) supevised by obstetricians, through a smartphone application and some werable devices (like sports bracelet). The pivotal AI are based on clinical experience from obstetricians, therapeutic principle from official Guidelines and abundant data in previous work, and it will works under strict supervision. | Other | Digitalized management group |
Primary outcome
Concentration of glycosylated hemoglobin A1c
Time frame: 37-42 weeks of gestation
Reflecting the average glucose level in the last 8-12 weeks
4 secondary outcomes
Rate of neonate large for gestational age
Time frame: At the 1 day of delivery
rate of caesarean as the delivery mode
Time frame: At the 1 day of delivery
Hospitalization cost of neonate and puerperae for delivery
Time frame: At the 1 day discharging from hospital
Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test
Time frame: 42 days postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 40353986Du M, Yi S, Wei Y, Jiang Y, Bao S, Lu J, Chen D. Effect of FSL-CGM on Maternal and Neonatal Outcomes in GDM: A Propensity Score Matching Study in Hangzhou, China. Diabetes Ther. 2025 Jul;16(7):1385-1397. doi: 10.1007/s13300-025-01749-0. Epub 2025 May 12.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitalized management in people with Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danqing Chen, PhD (+860571-87061501, chendq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of glycosylated hemoglobin A1c (time frame: 37-42 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003154, which also lists 1 linked publication.
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 12 Aug 2021.