eHealth in Treatment of Gestational Diabetes (eMOMGDM) — eMOMGDM  

Gestational Diabetes Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Mobile Application

• NCT number: NCT04714762
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2021
• Completion date: December 2024