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Digitalized Management Exploration for Gestational Diabetes Mellitus in China

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Digitalized management
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Danqing Chen

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional management group

Digitalized management group

Arm Description

Received conventional management based on Guidelines for GDM in China

Reveived conventional management and digitalized management

Outcomes

Primary Outcome Measures

Concentration of glycosylated hemoglobin A1c
Reflecting the average glucose level in the last 8-12 weeks

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2021
Last Updated
August 11, 2021
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Hangzhou Jianhai Technology Company Limited, Quzhou Maternal and Child Health Care Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05003154
Brief Title
Digitalized Management Exploration for Gestational Diabetes Mellitus in China
Official Title
Comparison of Conventional Mode and Combined Digitalized Mode of Management for Gestational Diabetes Mellitus in China
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborators
Hangzhou Jianhai Technology Company Limited, Quzhou Maternal and Child Health Care Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional management group
Arm Type
No Intervention
Arm Description
Received conventional management based on Guidelines for GDM in China
Arm Title
Digitalized management group
Arm Type
Experimental
Arm Description
Reveived conventional management and digitalized management
Intervention Type
Other
Intervention Name(s)
Digitalized management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Concentration of glycosylated hemoglobin A1c
Description
Reflecting the average glucose level in the last 8-12 weeks
Time Frame
37-42 weeks of gestation
Secondary Outcome Measure Information:
Title
Rate of neonate large for gestational age
Description
May reflecting maternal glucose level in pregnancy
Time Frame
At the 1 day of delivery
Title
rate of caesarean as the delivery mode
Description
An indicator associated with fetal weight or perinatal condition
Time Frame
At the 1 day of delivery
Title
Hospitalization cost of neonate and puerperae for delivery
Description
A health economic indicator
Time Frame
At the 1 day discharging from hospital
Title
Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test
Description
Reflecting postpartum glucose metabolism
Time Frame
42 days postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danqing Chen, PhD
Phone
+860571-87061501
Email
chendq@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Menglin Zhou, MD
Phone
+8613738008135
Email
marlin_zhou@zju.edu.cn
Facility Information:
Facility Name
Danqing Chen
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

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Digitalized Management Exploration for Gestational Diabetes Mellitus in China

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