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Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients

NCT04368741 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-30

No results posted yet for this study

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 nutrition product (SANZ®KINGWILL) in GDM patients, based on Continuous Glucose Monitoring (San MediTech CGM-303).

Conditions

  • SANZ®KINGWILL Combined With CGM Equipment in GDM Patients
  • GLUCERNA SR® Combined With CGM Equipment in GDM Patients

Interventions

DIETARY_SUPPLEMENT

SANZ®KINGWILL

20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.

DIETARY_SUPPLEMENT

GLUCERNA SR®

17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.

Sponsors & Collaborators

  • San MediTech(Huzhou)Co.,Ltd.

    collaborator UNKNOWN

  • Sanz Pharmaceutical Group

    collaborator UNKNOWN

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Beijing Obstetrics and Gynecology Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Shuli He, attending · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368741 on ClinicalTrials.gov