Mobile app for managing gestational diabetes in pregnant women
Official title: The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)
Run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · NCT05179798 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study tests if a mobile app that gives personalized diet and lifestyle tips can help pregnant women with gestational diabetes manage their condition better than standard care alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 216 (estimated) |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT05179798 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged over 18, diagnosed with GDM, and between 12 to 32 weeks of gestation.
✕Probably not a fit
Patients with preexisting diabetes, those requiring insulin therapy, or with certain medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial evaluates the effectiveness of DiaCompanion, a mobile-based recommendation system, in managing gestational diabetes mellitus (GDM) among women. Participants are divided into two groups: one using the app for personalized dietary and lifestyle recommendations based on their glucose levels, and the other receiving standard care without the app. The study collects data on glycemic levels and dietary intake to assess the impact of the app on maternal and fetal outcomes. Additionally, biological samples will be collected for future research on GDM.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycemic control and pregnancy outcomes for women with gestational diabetes.
How similar studies have gone: Other studies have shown promise in using mobile health applications for diabetes management, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation Recruiting
Study contacts
- Study coordinator: Polina Popova, Ph. D.
- Email: popova_pv@almazovcentre.ru
- Phone: +79217424404
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.