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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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)
Helsinki University Hospital
Helsinki, Finland
Change in fasting glucose
change in fasting glucose measured by Huslab (laboratory measurement)
Time frame: from gestational weeks 24-28 to gestational weeks 35-37
Fingertips fasting glucose values
Measured with Contour Next One
Time frame: from gestational weeks 24-28 up to delivery
Fingertips postbrandial glucose values
Measured with Contour Next One
Time frame: from gestational weeks 24-28 up to delivery
Fingertips area under the glucose curve
Measured with Contour Next One
Time frame: from gestational weeks 24-28 up to delivery
Gestational weight
Measured with Seca Mod 8787041649 (scale) and registered from antenatal card
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
Postpartum weight
Measured with Seca Mod 8787041649 (scale)
Time frame: weight measured at 3 months postpartum
Physical activity level
Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2
Time frame: at gestational weeks 24-28, 35-37 and at 3 months postpartum
Total diet
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.
Time frame: at gestational weeks 24-28), 35-37 and at 3 months postpartum
Neonatal body fat%
Measured with PEA POD Cosmed
Time frame: one measure within 0-3 days after birth of the child
Motivation to manage GDM
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.
Time frame: at gestational weeks 24-28 and 35-37
Percentage of participants on metformin treatment
Percentage of participants need for metformin treatment
Time frame: up to 42 gestational weeks
Percentage of participants on insulin treatment
Percentage of participants need for insulin treatment
Time frame: up to 42 gestational weeks
Newborn birthweight and macrosomia
Newborn birth weight and macrosomia (birthweight \>4kg)
Time frame: one measure at birth
Incidence of neonatal hypoglycemia
Percentage of neonatal hypoglycemia requiring intravenous glucose
Time frame: within a week from birth
Incidence of newborn large for gestational age
Percentage of newborn with birthweight percentile \> + 2 SD
Time frame: one measure at birth
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Time frame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
2-h OGTT
2-hour blood glucose levels measured with OGTT (75g)
Time frame: 3 months postpartum
Stress levels
Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages.
Time frame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
Costs
Costs of the intervention and treatment in healthcare. Defined as €/participant.
Time frame: gestational weeks 24-28, 3 months postpartum
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