NCT05179798

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

October 30, 2021

Last Update Submit

January 25, 2022

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

gestational diabetes mellitusglycemic targetsmHealthpersonalized medicinerecommendation systempersonalized nutritionpostprandial glycemic response

Outcome Measures

Primary Outcomes (1)

  • Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)

    The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.

    from randomization up to delivery

Secondary Outcomes (34)

  • Rate of patients requiring insulin therapy during pregnancy

    At any time during pregnancy up to delivery

  • Capillary glucose values

    within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery

  • Proportion of women with glucose values within target

    within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery

  • Mean incremental area under the blood glucose curve 2 hours after meals (iAUC120) according to continuous glucose monitoring (time period: 7 days)

    1-2 weeks after randomization and 35-37th gestational week

  • Hypoglycemia

    from randomization to delivery

  • +29 more secondary outcomes

Study Arms (2)

Mobile app

EXPERIMENTAL

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

Device: mobile app

Standard of care

NO INTERVENTION

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

Interventions

mobile appDEVICE

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

Also known as: recommendation system
Mobile app

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

RECRUITING

Related Publications (4)

  • Pustozerov E, Tkachuk A, Vasukova E, Dronova A, Shilova E, Anopova A, Piven F, Pervunina T, Vasilieva E, Grineva E, Popova P. The Role of Glycemic Index and Glycemic Load in the Development of Real-Time Postprandial Glycemic Response Prediction Models for Patients With Gestational Diabetes. Nutrients. 2020 Jan 23;12(2):302. doi: 10.3390/nu12020302.

    PMID: 31979294BACKGROUND

  • Pustozerov E.A., Tkachuck A.S., Vasukova E.A., Anopova A.D., Kokina M.A., Gorelova I.V., Pervunina T.M., Grineva E.N., Popova P.V. Machine Learning Approach for Postprandial Blood Glucose Prediction in Gestational Diabetes Mellitus. IEEE Access, vol. 8, pp. 219308-219321, 2020, doi: 10.1109/ACCESS.2020.3042483.

    BACKGROUND

  • Pustozerov E, Popova P, Tkachuk A, Bolotko Y, Yuldashev Z, Grineva E. Development and Evaluation of a Mobile Personalized Blood Glucose Prediction System for Patients With Gestational Diabetes Mellitus. JMIR Mhealth Uhealth. 2018 Jan 9;6(1):e6. doi: 10.2196/mhealth.9236.

    PMID: 29317385BACKGROUND

  • Popova P, Anopova A, Vasukova E, Isakov A, Eriskovskaya A, Degilevich A, Pustozerov E, Tkachuk A, Pashkova K, Krasnova N, Kokina M, Nemykina I, Pervunina T, Li O, Grineva E, Shlyakhto E. Trial protocol for the study of recommendation system DiaCompanion with personalized dietary recommendations for women with gestational diabetes mellitus (DiaCompanion I). Front Endocrinol (Lausanne). 2023 Jun 7;14:1168688. doi: 10.3389/fendo.2023.1168688. eCollection 2023.

    PMID: 37361536DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Polina Popova, Ph. D.

CONTACT

+79217424404popova_pv@almazovcentre.ru

Evgenii Pustozerov, Ph. D.

CONTACT

+79213684589pustozerov.e@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the research laboratory of methabolic disorders and microbiota

Study Record Dates

First Submitted

October 30, 2021

First Posted

January 5, 2022

Study Start

January 12, 2022

Primary Completion

January 1, 2025

Study Completion

August 1, 2025

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations

RU(1)