Digitalized Management Exploration for Gestational Diabetes Mellitus in China

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Comparison of Conventional Mode and Combined Digitalized Mode of Management for Gestational Diabetes Mellitus in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05003154
• Other study ID #: GDMDM2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2021
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Danqing Chen, PhD
• Phone: +860571-87061501
• Email: chendq[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: August 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Danqing Chen	HangZhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Hangzhou Jianhai Technology Company Limited, Quzhou Maternal and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of glycosylated hemoglobin A1c	Reflecting the average glucose level in the last 8-12 weeks	37-42 weeks of gestation
Secondary	Rate of neonate large for gestational age	May reflecting maternal glucose level in pregnancy	At the 1 day of delivery
Secondary	rate of caesarean as the delivery mode	An indicator associated with fetal weight or perinatal condition	At the 1 day of delivery
Secondary	Hospitalization cost of neonate and puerperae for delivery	A health economic indicator	At the 1 day discharging from hospital
Secondary	Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test	Reflecting postpartum glucose metabolism	42 days postpartum