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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial

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

Intervention / Treatment
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* Dietary Supplement: SANZ®KINGWILL
* Dietary Supplement: GLUCERNA SR®


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>SANZ®KINGWILL | Dietary Supplement: SANZ®KINGWILL<br>* 20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.<br>|
| Other: Control group<br>GLUCERNA SR® | Dietary Supplement: GLUCERNA SR®<br>* 17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition product, continuous glucose monitoring, gestational diabetes mellitus