eHealth in Treatment of Gestational Diabetes (eMOMGDM) (eMOMGDM)

University of Helsinki, Aalto University, UKK Institute, Tampere University, Finnish Institute for Health and Welfare, Fujitsu, Elisa Oyj, Business Finland

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: continuous glucose monitor (CGM) fingertips glucose calibration according to CGM protocol (twice per day with Medtronic) 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. heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3) 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

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

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).

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.

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)

weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery

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.

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.

Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.

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)

All data will be collected in Helsinki University Hospital Datalake from where pseudo-anonymised data can be requested until 2032 via a data sharing contract. Proposals should be directed to tietopalvelu(a)hus.fi.

Kyto M, Markussen LT, Marttinen P, Jacucci G, Niinisto S, Virtanen SM, Korhonen TE, Sievanen H, Vaha-Ypya H, Korhonen I, Heinonen S, Koivusalo SB. Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study). BMJ Open. 2022 Nov 7;12(11):e066292. doi: 10.1136/bmjopen-2022-066292.