Gestational Diabetes, Mobile Application
Conditions
Keywords
gestational diabetes, continuous glucose monitoring, physical activity, nutrition, behaviour change, stress, recovery, human-computer interaction, mobile application, self tracking
Brief 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
Interventions
DEVICEeMOM 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)
Sponsors
University of Helsinki
Aalto University
UKK Institute
Tampere University
Finnish Institute for Health and Welfare
Fujitsu
Elisa Oyj
Business Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Data will be anonomized (ID coded)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting glucose | from gestational weeks 24-28 to gestational weeks 35-37 | change in fasting glucose measured by Huslab (laboratory measurement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fingertips postbrandial glucose values | from gestational weeks 24-28 up to delivery | Measured with Contour Next One |
| Fingertips area under the glucose curve | from gestational weeks 24-28 up to delivery | Measured with Contour Next One |
| Gestational weight | 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 Seca Mod 8787041649 (scale) and registered from antenatal card |
| Postpartum weight | weight measured at 3 months postpartum | Measured with Seca Mod 8787041649 (scale) |
| Physical activity level | at gestational weeks 24-28, 35-37 and at 3 months postpartum | Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2 |
| Total diet | at gestational weeks 24-28), 35-37 and at 3 months postpartum | 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. |
| Neonatal body fat% | one measure within 0-3 days after birth of the child | Measured with PEA POD Cosmed |
| Motivation to manage GDM | at gestational weeks 24-28 and 35-37 | 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. |
| Fingertips fasting glucose values | from gestational weeks 24-28 up to delivery | Measured with Contour Next One |
| Percentage of participants on insulin treatment | up to 42 gestational weeks | Percentage of participants need for insulin treatment |
| Newborn birthweight and macrosomia | one measure at birth | Newborn birth weight and macrosomia (birthweight \>4kg) |
| Incidence of neonatal hypoglycemia | within a week from birth | Percentage of neonatal hypoglycemia requiring intravenous glucose |
| Incidence of newborn large for gestational age | one measure at birth | Percentage of newborn with birthweight percentile \> + 2 SD |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. |
| 2-h OGTT | 3 months postpartum | 2-hour blood glucose levels measured with OGTT (75g) |
| Stress levels | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages. |
| Costs | gestational weeks 24-28, 3 months postpartum | Costs of the intervention and treatment in healthcare. Defined as €/participant. |
| Percentage of participants on metformin treatment | up to 42 gestational weeks | Percentage of participants need for metformin treatment |
Countries
Finland
Outcome results
None listed