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eSanté dans le traitement du diabète gestationnel (eMOMGDM) (eMOMGDM)

23 septembre 2026 mis à jour par: Saila Koivusalo, Helsinki University Central Hospital

eSanté dans le traitement du diabète gestationnel - eMOM GDM -Étude (Phase 2)

The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way.

In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

200 women with gestational diabetes will be randomized into the intervention and the control group at gestational week (GW) 24-28.

Participants in the intervention group will use the eMOM GDM -application one week/month until delivery.

The participants in the intervention and the control group visit study nurse 3 times in study period (at GW 24-28 and GW 35-37 and 3 months postpartum).

Both groups also receive regular antenatal care in maternity clinics and hospitals.

Maternal measurements at enrollment, and at 35-37 GW (both groups):

  • Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP
  • Fingertips glucose values from glucose meter (belong to normal antenatal care)
  • Fasting blood samples for future analyses
  • Weight, height, blood pressure (from the antenatal registry and study visits)
  • Questionnaires: background (only at enrollment), diet (food frequency questionnaire), depression (EPDS), motivation (TSRQ+PCS), quality of life (15D)
  • Physical activity and sedentary behavior with the hip-worn triaxial accelerometer (UKK RM 42)
  • Physical activity and heart rate with Firstbeat Bodyguard

Measurements at Birth:

  • Cord blood sample
  • Placental weight
  • Offspring birthweight, height, body composition (PEA POD Cosmed®)

Maternal measurements at 3 months postpartum:

  • Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP
  • fp-gluc, 2h postprandial value, as measured during oral glucose tolerance test (OGTT)
  • Fasting blood samples for future analyses
  • Firstbeat Bodyguard 2 measurement (3 days)
  • Depression questionnaire (EPDS)
  • Diet questionnaire (FFQ)

Protocol only for the intervention group

- eMOM GDM application: use: 1 application week + 3 normal care weeks repeatedly until delivery

The application includes:

  1. continuous glucose monitor (CGM)

    • fingertips glucose calibration according to CGM protocol (twice per day with Medtronic)

  2. diet (digital food tracker)

    • 3 days during one application week
    • For ensuring the quality of food record a researcher will phone interview the participant based on her recordings. This is done after each recording period.

  3. heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)

  4. weight measured once a week

Data from the sensors

  • Data from users' input to the application
  • Technology acceptance questionnaire (UTAUT) after every application week
  • Usability questionnaire, after four weeks usage of the eMOM GDM application
  • Semi-structured interview

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Finlande
      • Helsinki, Finlande, 00029
        • Helsinki University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • GDM diagnoses at 24-28 gestational weeks

Exclusion Criteria:

  • type 1 or type 2 diabetes
  • use of medication that influences glucose metabolism (such as continuous therapy with oral corticosteroids or metformin)
  • multiple pregnancy
  • physical disability
  • current substance abuse
  • severe psychiatric disorder (that complicates participation to the study)
  • significant difficulty in cooperating (e.g. inadequate Finnish language skills)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention (eMOM GDM application)

Participants in the intervention group will use the eMOM GDM -application one week/month. The participants will also receive regular antenatal care in maternity clinics and hospitals. In addition they will meet a study nurse three times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum).
Dispositif: eMOM GDM application

Participants in the intervention group will use the eMOM GDM -application one week/month.

eMOM GDM application includes:

  • continuous glucose monitor (CGM, Medtronic)
  • diet (digital food tracker) (min 3 days during one application week)
  • heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
  • weight measured once a week

The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)
Aucune intervention: Control

Participants in the control group will meet a study nurse 3 times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum). They also receive regular antenatal care in maternity clinics and hospitals.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in fasting glucose
Délai: from gestational weeks 24-28 to gestational weeks 35-37

change in fasting glucose measured by Huslab (laboratory measurement)
from gestational weeks 24-28 to gestational weeks 35-37

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fingertips fasting glucose values
Délai: from gestational weeks 24-28 up to delivery

Measured with Contour Next One
from gestational weeks 24-28 up to delivery
Fingertips postbrandial glucose values
Délai: from gestational weeks 24-28 up to delivery

Measured with Contour Next One
from gestational weeks 24-28 up to delivery
Fingertips area under the glucose curve
Délai: from gestational weeks 24-28 up to delivery

Measured with Contour Next One
from gestational weeks 24-28 up to delivery
Gestational weight
Délai: weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery

Measured with Seca Mod 8787041649 (scale) and registered from antenatal card
weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery
Postpartum weight
Délai: weight measured at 3 months postpartum

Measured with Seca Mod 8787041649 (scale)
weight measured at 3 months postpartum
Physical activity level
Délai: at gestational weeks 24-28, 35-37 and at 3 months postpartum

Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2
at gestational weeks 24-28, 35-37 and at 3 months postpartum
Total diet
Délai: at gestational weeks 24-28), 35-37 and at 3 months postpartum

Measured with a questionnaire (food frequencey questionnaire, FFQ) concerning participant's diet during previous month. FFQ contains questions about the frequency (number of times per day, week, or month) and the amount of foods consumed in units of common serving sizes. Nutritional quality of total diet is assessed based on calculated daily consumption of foods and intake of nutrients. Better nutritional quality is related to e.g. higher intake of fruits and vegetables, wholegrain cereals, fiber and unsaturated fat, and lower intake of added sugar and saturated fat.
at gestational weeks 24-28), 35-37 and at 3 months postpartum
Neonatal body fat%
Délai: one measure within 0-3 days after birth of the child

Measured with PEA POD Cosmed
one measure within 0-3 days after birth of the child
Motivation to manage GDM
Délai: at gestational weeks 24-28 and 35-37

Measured with a motivation questionnaire (TSRQ and PCS). Minimum value is 1 and maximum 5. The higher score means higher autonomous motivation to manage GDM.
at gestational weeks 24-28 and 35-37
Percentage of participants on metformin treatment
Délai: up to 42 gestational weeks

Percentage of participants need for metformin treatment
up to 42 gestational weeks
Percentage of participants on insulin treatment
Délai: up to 42 gestational weeks

Percentage of participants need for insulin treatment
up to 42 gestational weeks
Newborn birthweight and macrosomia
Délai: one measure at birth

Newborn birth weight and macrosomia (birthweight >4kg)
one measure at birth
Incidence of neonatal hypoglycemia
Délai: within a week from birth

Percentage of neonatal hypoglycemia requiring intravenous glucose
within a week from birth
Incidence of newborn large for gestational age
Délai: one measure at birth

Percentage of newborn with birthweight percentile > + 2 SD
one measure at birth
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Délai: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum

Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
2-h OGTT
Délai: 3 months postpartum

2-hour blood glucose levels measured with OGTT (75g)
3 months postpartum
Stress levels
Délai: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum

Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages.
gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
Costs
Délai: gestational weeks 24-28, 3 months postpartum

Costs of the intervention and treatment in healthcare. Defined as €/participant.
gestational weeks 24-28, 3 months postpartum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Helsinki University Central Hospital

Collaborateurs

University of Helsinki
Tampere University
Aalto University
Finnish Institute for Health and Welfare
UKK Institute
Business Finland
Elisa Oyj
Fujitsu

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 mars 2021

Achèvement primaire (Réel)

12 décembre 2022

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

11 janvier 2021

Première soumission répondant aux critères de contrôle qualité

15 janvier 2021

Première publication (Réel)

19 janvier 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HUS/2165/2018-Phase 2

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All data will be collected in Helsinki University Hospital Datalake from where pseudo-anonymised data can be requested until 2032 via a data sharing contract. Proposals should be directed to tietopalvelu(a)hus.fi.

Délai de partage IPD

Until 2032

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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