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

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

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).

Study Overview

• Status: Unknown
• Conditions: SANZ®KINGWILL Combined With CGM Equipment in GDM Patients; GLUCERNA SR® Combined With CGM Equipment in GDM Patients
• Intervention / Treatment: Dietary supplement: SANZ®KINGWILL; Dietary supplement: GLUCERNA SR®

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feiling Huang, master; Phone Number: 18510875983; Email: huangfeiling_13@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Liangkun Ma, doctor; Phone Number: +8613021961166; Email: maliangkun@pumch.cn
      • Contact: Feiling Huang, master; Phone Number: +8618510875983; Email: huangfeiling_13@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Chao Yang Hospital; Beijing Obstetrics and Gynecology Hospital; San MediTech(Huzhou)Co.,Ltd.; Sanz Pharmaceutical Group
• Investigators: Principal Investigator: Shuli He, attending, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; gestational diabetes mellitus; nutrition product
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: ZS-2103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No