Digitalized Management Exploration for Gestational Diabetes Mellitus in China

Not Applicable

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: Digitalized management

• Registration Number: NCT05003154
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Study Start: 2021-09
• Primary Completion: 2024-01
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digitalized management group	Digitalized management	Reveived conventional management and digitalized management

Primary Outcome Measures

Name	Time	Method
Concentration of glycosylated hemoglobin A1c	37-42 weeks of gestation	Reflecting the average glucose level in the last 8-12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of neonate large for gestational age	At the 1 day of delivery	May reflecting maternal glucose level in pregnancy
rate of caesarean as the delivery mode	At the 1 day of delivery	An indicator associated with fetal weight or perinatal condition
Hospitalization cost of neonate and puerperae for delivery	At the 1 day discharging from hospital	A health economic indicator
Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test	42 days postpartum	Reflecting postpartum glucose metabolism

Trial Locations

Locations (1)

Danqing Chen; 🇨🇳 HangZhou, Zhejiang, China