Digitalized Management Exploration for Gestational Diabetes Mellitus in China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Digitalized management

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danqing Chen, PhD; Phone Number: +860571-87061501; Email: chendq@zju.edu.cn
• Study Contact Backup: Name: Menglin Zhou, MD; Phone Number: +8613738008135; Email: marlin_zhou@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310006
      • Danqing Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional management group; Received conventional management based on Guidelines for GDM in China
Experimental: Digitalized management group; Reveived conventional management and digitalized management	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of glycosylated hemoglobin A1c	Reflecting the average glucose level in the last 8-12 weeks	37-42 weeks of gestation

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: GDMDM2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No