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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SANZ®KINGWILL
GLUCERNA SR®
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SANZ®KINGWILL Combined With CGM Equipment in GDM Patients focused on measuring nutrition product, continuous glucose monitoring, gestational diabetes mellitus

Eligibility Criteria

22 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

SANZ®KINGWILL

GLUCERNA SR®

Outcomes

Primary Outcome Measures

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
Changes of Weight
Area under the blood glucose curve (AUC)
Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.
Blood glucose control outcome
Fasting blood glucose
Glycated albumin level

Secondary Outcome Measures

Full Information

First Posted
December 1, 2019
Last Updated
April 29, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
San MediTech(Huzhou)Co.,Ltd., Sanz Pharmaceutical Group, Beijing Chao Yang Hospital, Beijing Obstetrics and Gynecology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04368741
Brief Title
Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients
Official Title
Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
San MediTech(Huzhou)Co.,Ltd., Sanz Pharmaceutical Group, Beijing Chao Yang Hospital, Beijing Obstetrics and Gynecology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SANZ®KINGWILL Combined With CGM Equipment in GDM Patients, GLUCERNA SR® Combined With CGM Equipment in GDM Patients
Keywords
nutrition product, continuous glucose monitoring, gestational diabetes mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
SANZ®KINGWILL
Arm Title
Control group
Arm Type
Other
Arm Description
GLUCERNA SR®
Intervention Type
Dietary Supplement
Intervention Name(s)
SANZ®KINGWILL
Intervention Description
20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.
Intervention Type
Dietary Supplement
Intervention Name(s)
GLUCERNA SR®
Intervention Description
17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.
Primary Outcome Measure Information:
Title
Number of other product-related/possibly related adverse events or serious adverse events
Description
Number of other product-related/possibly related adverse events or serious adverse events
Time Frame
4 weeks
Title
Changes of Weight
Time Frame
4 weeks
Title
Area under the blood glucose curve (AUC)
Description
Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.
Time Frame
4 weeks
Title
Blood glucose control outcome
Description
Fasting blood glucose
Time Frame
4 weeks
Title
Glycated albumin level
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangkun Ma, doctor
Phone
13021961166
Email
maliangkun@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Feiling Huang, master
Phone
18510875983
Email
huangfeiling_13@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuli He, attending
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangkun Ma, doctor
Phone
+8613021961166
Email
maliangkun@pumch.cn
First Name & Middle Initial & Last Name & Degree
Feiling Huang, master
Phone
+8618510875983
Email
huangfeiling_13@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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