Digitalized Management Exploration for Gestational Diabetes Mellitus in China

NCT05003154 | Unknown

• 1 other identifier: GDMDM2021
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Concentration of glycosylated hemoglobin A1c

  Reflecting the average glucose level in the last 8-12 weeks

  37-42 weeks of gestation

Secondary Outcomes (4)

• Rate of neonate large for gestational age

  At the 1 day of delivery

• rate of caesarean as the delivery mode

  At the 1 day of delivery

• Hospitalization cost of neonate and puerperae for delivery

  At the 1 day discharging from hospital

• Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test

  42 days postpartum

Study Arms (2)

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

Other: Digitalized management

Interventions

Digitalized management 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.

Digitalized management group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Hangzhou Jianhai Technology Company Limited: collaborator
• Quzhou Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

Danqing Chen

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

• 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.

  PMID: 40353986 DERIVED

Central Study Contacts

Danqing Chen, PhD

CONTACT

+860571-87061501; chendq@zju.edu.cn

Menglin Zhou, MD

CONTACT

+8613738008135; marlin_zhou@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 12, 2021

Record last verified: 2021-07

Locations

CN (1)