Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT04368741|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|SANZ®KINGWILL Combined With CGM Equipment in GDM Patients GLUCERNA SR® Combined With CGM Equipment in GDM Patients||Dietary Supplement: SANZ®KINGWILL Dietary Supplement: GLUCERNA SR®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Experimental group
Dietary Supplement: SANZ®KINGWILL
20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.
Dietary Supplement: GLUCERNA SR®
17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.
- Number of other product-related/possibly related adverse events or serious adverse events [ Time Frame: 4 weeks ]Number of other product-related/possibly related adverse events or serious adverse events
- Changes of Weight [ Time Frame: 4 weeks ]
- Area under the blood glucose curve (AUC) [ Time Frame: 4 weeks ]Area under the blood glucose curve (AUC) by CGM within 2 hours of using the nutrition product.
- Blood glucose control outcome [ Time Frame: 4 weeks ]Fasting blood glucose
- Glycated albumin level [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368741
|Contact: Liangkun Ma, firstname.lastname@example.org|
|Contact: Feiling Huang, email@example.com|
|Principal Investigator:||Shuli He, attending||Peking Union Medical College Hospital|