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Active, Not Recruiting

NCT Number: NCT04714762

eHealth in Treatment of Gestational Diabetes (eMOMGDM)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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:

  • continuous glucose monitor (CGM)
  • fingertips glucose calibration according to CGM protocol (twice per day with Medtronic)
  • 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.
  • heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

eMOM GDM application

Device

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)

Primary outcomes

  1. Change in fasting glucose

    Time frame: from gestational weeks 24-28 to gestational weeks 35-37

    change in fasting glucose measured by Huslab (laboratory measurement)

Secondary outcomes

  1. Fingertips fasting glucose values

    Time frame: from gestational weeks 24-28 up to delivery

    Measured with Contour Next One

  2. Fingertips postbrandial glucose values

    Time frame: from gestational weeks 24-28 up to delivery

    Measured with Contour Next One

  3. Fingertips area under the glucose curve

    Time frame: from gestational weeks 24-28 up to delivery

    Measured with Contour Next One

  4. Gestational weight

    Time frame: 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

  5. Postpartum weight

    Time frame: weight measured at 3 months postpartum

    Measured with Seca Mod 8787041649 (scale)

  6. Physical activity level

    Time frame: at gestational weeks 24-28, 35-37 and at 3 months postpartum

    Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2

  7. Total diet

    Time frame: 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.

  8. Neonatal body fat%

    Time frame: one measure within 0-3 days after birth of the child

    Measured with PEA POD Cosmed

  9. Motivation to manage GDM

    Time frame: 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.

  10. Percentage of participants on metformin treatment

    Time frame: up to 42 gestational weeks

    Percentage of participants need for metformin treatment

  11. Percentage of participants on insulin treatment

    Time frame: up to 42 gestational weeks

    Percentage of participants need for insulin treatment

  12. Newborn birthweight and macrosomia

    Time frame: one measure at birth

    Newborn birth weight and macrosomia (birthweight >4kg)

  13. Incidence of neonatal hypoglycemia

    Time frame: within a week from birth

    Percentage of neonatal hypoglycemia requiring intravenous glucose

  14. Incidence of newborn large for gestational age

    Time frame: one measure at birth

    Percentage of newborn with birthweight percentile > + 2 SD

  15. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 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.

  16. 2-h OGTT

    Time frame: 3 months postpartum

    2-hour blood glucose levels measured with OGTT (75g)

  17. Stress levels

    Time frame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum

    Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages.

  18. Costs

    Time frame: gestational weeks 24-28, 3 months postpartum

    Costs of the intervention and treatment in healthcare. Defined as €/participant.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

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

Registry information

Official study title

eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)

Acronym: eMOMGDM

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Jan 19, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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