NCT05179798

The Study of Recommendation System DiaCompanion for Women With Gestational Diabetes Mellitus

The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
DEVICE	mobile app	Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.

Timeline

• Start date: 2022-01-12
• Primary completion: 2025-01-01
• Completion: 2025-08-01
• First posted: 2022-01-05
• Last updated: 2022-02-08

Locations

1 site across 1 country: Russia