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

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Status: Enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Device: mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT05179798

DiaCompanion I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women diagnosed with GDM according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. fasting plasma glucose between 5.1 mmol/L and 6.9 mmol/L after the 6th week of gestation and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 10.0 mmol/L and/or 2-hour plasma glucose value between 8.5 mmol/L and 11.0 mmol/L at the 24-31st week of gestation
• Age >18 years
• Gestational age >= 12 and < 32 weeks
• No more than 4 weeks after confirmation of GDM diagnosis
• Singleton pregnancy
• The ability to navigate an app
• Provided informed consent

Exclusion criteria

• Preexisting diabetes of any type before the current pregnancy
• Need for insulin therapy at the time of screening
• Heart failure
• Chronic kidney disease
• History of bariatric surgery
• Use of long-term systemic corticosteroids
• Impaired mobility
• Known fetal malformations
• Concomitant participation in other clinical trials

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Mobile app

Experimental group

Description:

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

Treatment:

Device: mobile app

Standard of care

No Intervention group

Description:

Lifestyle modification, insulin therapy if needed; conventional care without a mobile app.