Clinical trial NCT04368741: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: San MediTech(Huzhou)Co.,Ltd.
name: Sanz Pharmaceutical Group
name: Beijing Chao Yang Hospital
name: Beijing Obstetrics and Gynecology Hospital
First posted: 2020-04-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of other product-related/possibly related adverse events or serious adverse events
timeFrame: 4 weeks
measure: Changes of Weight
timeFrame: 4 weeks
measure: Area under the blood glucose curve (AUC)
timeFrame: 4 weeks
measure: Blood glucose control outcome
timeFrame: 4 weeks
measure: Glycated albumin level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shuli He, attending
role: PRINCIPAL_INVESTIGATOR
References: