ehealth in treatment of gestational diabetes (emomgdm)

Conditions: Gestational Diabetes; Mobile Application

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.

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

Eligibility criteria:
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)

Keywords: gestational diabetes continuous glucose monitoring physical activity nutrition behaviour change stress recovery human-computer interaction mobile application self tracking