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

Not Applicable

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

• Registration Number: NCT04368741
• Lead Sponsor: Peking Union Medical College Hospital

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

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 enrolled. Using the double-blind method, they were randomly divided into two groups: experimental group and control group. Both of the two groups were provided medical nutrition treatment by nutritionist after GDM was diagnosed and CGM equipment (San MediTech CGM-303) was worn. Blood and urine samples were collected. At the following two days, oatmeal (SHIZHUANG) was used as extra meal at 10:00am and 15:00pm in both groups. In the next 4 weeks experimental group was provided with the domestic nutrition product (SANZ®KINGWILL), while existing products (GLUCERNA SR®) for control group as their extra meals at 10:00am and 15:00pm. In the last day, CGM equipment (San MediTech CGM-303) was removed and blood and urine samples were collected.

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-10-15
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-04-30
• Last Update Posted: 2020-04-30
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent

Exclusion Criteria

• 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.

  2. Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.

  3. Patients who cannot tolerate enteral nutrition. 6. Patients with other conditions which investigator believes they are not eligible for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of other product-related/possibly related adverse events or serious adverse events	4 weeks	Number of other product-related/possibly related adverse events or serious adverse events
Glycated albumin level	4 weeks
Changes of Weight	4 weeks
Area under the blood glucose curve (AUC)	4 weeks	Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.
Blood glucose control outcome	4 weeks	Fasting blood glucose

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China