Effectiveness and Safety of Nutrition Product in Gestational Diabetes Mellitus Patients, Based on Continuous Glucose Monitoring, a Prospective Randomized Controlled Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 15, 2019
Actual (reported)Primary Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2019
Actual (reported)December 1, 2019
Actual (reported)April 30, 2020
Actual (reported)October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
SANZ®KINGWILL
GLUCERNA SR®
20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.
17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Shuli He, attending
Peking Union Medical College Hospital
First Submitted
December 1, 2019
First Posted
April 30, 2020
Study Start
October 15, 2019
Actual (reported)Primary Completion
October 2020
Estimated (date passed)Glycated albumin level
4 weeks
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2020
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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