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Clinical Trial Summary

This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. This study is an interventional, randomized controlled trial, open-labeled.


Clinical Trial Description

The study aims to clarify the effect of using DiaCompanion I (a mobile-based personalized recommendations system) on glycemic levels and pregnancy outcomes in women with GDM. Women with GDM are randomized to 2 treatment groups (utilizing and not utilizing the developed mobile-based system with data-driven personal recommendations focused primarily on postprandial glycemic response prediction). Data on glycemic levels during the study and consumption of major macro- and micronutrients will be collected using the mobile app with electronic report forms. The app provides women in the intervention group with the resulting data-driven prognosis of a 1-hour postprandial glucose level every time they input their meal data. The app also provides participants of the intervention group with a set of reminders and recommendations on the diet and lifestyle. Apart from the assessment of the outcomes described below, biobanking of serum, plasma; cord fluid, HUVECs, faeces, and meconium will be performed. The samples may be used for further analyses in ancillary studies, which could be beneficial for GDM care based on evolution in scientific knowledge. This biological collection is optional [Time Frame: within 15 years after the end of the study]: - The blood samples will be collected at the same time as the sample routinely collected - Maternal faeces will be collected within 5 days after inclusion and at gestational weeks 35-36 - Cord fluid will be collected - HUVECs will be isolated from the cord after delivery - Meconium will be collected within 24 hours after birth. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05179798
Study type Interventional
Source Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact
Status Enrolling by invitation
Phase N/A
Start date January 2022
Completion date August 2025

See also
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Completed NCT00911404 - Carbohydrate Restriction for Gestational Diabetes Mellitus N/A
Active, not recruiting NCT02025673 - Study of Betatrophin Levels in Patients With Type 2 Diabetes and Gestational Diabetes and Healthy Subjects N/A
Active, not recruiting NCT01554358 - Tianjin Gestational Diabetes Prevention Program (TGDPP) N/A