NCT04714762

eHealth in Treatment of Gestational Diabetes (eMOMGDM)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Gestational Diabetes
• Mobile Application

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-12-12
• Completion: 2026-12-31
• First posted: 2021-01-19
• Last updated: 2024-12-12

Locations

1 site across 1 country: Finland