Status:
UNKNOWN
Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
San MediTech(Huzhou)Co.,Ltd.
Sanz Pharmaceutical Group
Conditions:
SANZ®KINGWILL Combined With CGM Equipment in GDM Patients
GLUCERNA SR® Combined With CGM Equipment in GDM Patients
Eligibility:
FEMALE
22-40 years
Phase:
NA
Brief Summary
A prospective, multicenter, randomized controlled trial including about 60 Gestational Diabetes Mellitus patients (GDM) in Beijing will be included to evaluate the effectiveness and safety of nutritio...
Detailed Description
This study will recruit pregnant women who were diagnosed as GDM by 75g Oral glucose tolerance test (OGTT) in 2nd trimester and followed up for 1month. A total of 60 GDM patients were expected to be e...
Eligibility Criteria
Inclusion
- 1\. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent
Exclusion
- 1\. GDM patient who is no longer suitable to continue pregnancy. 2. Patients who use any hypoglycemic drugs or any type of similar products. 3. Patients who have diseases severely affected the nutrition product digestion and absorption.
- 4\. Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.
- 5\. Patients who cannot tolerate enteral nutrition. 6. Patients with other conditions which investigator believes they are not eligible for this study.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04368741
Start Date
October 15 2019
End Date
October 1 2020
Last Update
April 30 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730