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

Overview

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).

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.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

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