Digitalized Management Exploration for Gestational Diabetes Mellitus in China

NCT ID: NCT05003154

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-08-31

Brief 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. 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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional management group

Received conventional management based on Guidelines for GDM in China

Group Type: NO_INTERVENTION

No interventions assigned to this group

Digitalized management group

Reveived conventional management and digitalized management

Group Type: EXPERIMENTAL

Digitalized management

Intervention Type: OTHER

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.

Interventions

Digitalized management

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The age of 18-45 years, single pregnancy, Han nationality;

2. 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).

3. Plan to deliver the baby in Women's Hospital School Of Medicine Zhejiang University;

4. Can operate mobile phones and related software;

5. Voluntary participation in this study;

6. Education background: junior high school or above.

Exclusion Criteria

1. Type I or II or other non GDM diabetes mellitus;

2. 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;

3. 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;

4. Other conditions: such as mental disorders, cervical incompetence, genital tract deformity, etc;

5. Patients who are taking medicine that may affect glucose metabolism, such as ritodrine, prednisone, etc;

6. Patients who are participating in other clinical studies;

7. The researchers believe patients who are not suitable for this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Jianhai Technology Company Limited

UNKNOWN

Sponsor Role: collaborator

Quzhou Maternal and Child Health Care Hospital

UNKNOWN

Sponsor Role: collaborator

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Danqing Chen

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Danqing Chen, PhD

Role: CONTACT

chendq@zju.edu.cn

+860571-87061501

Menglin Zhou, MD

Role: CONTACT

marlin_zhou@zju.edu.cn

+8613738008135

References

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.

Reference Type: DERIVED

PMID: 40353986 (View on PubMed)

Other Identifiers

GDMDM2021

Identifier Type: -

Identifier Source: org_study_id