eHealth in Treatment of Gestational Diabetes (eMOMGDM)

Helsinki University Central Hospital (HUCH)

Status: Active, not recruiting

Conditions: Gestational Diabetes; Mobile Application

Treatments: Device: eMOM GDM application

Study type: Interventional

Funder types: Other

Identifiers

NCT04714762

HUS/2165/2018-Phase 2

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Intervention (eMOM GDM application)

Experimental group

Description:

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).

Treatment:

Device: eMOM GDM application

Control

No Intervention group

Description:

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.