eHealth in Treatment of Gestational Diabetes (eMOMGDM)

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gestational Diabetes, Mobile Application

Intervention / Treatment
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* Device: eMOM GDM application


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (eMOM GDM application)<br>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). | Device: eMOM GDM application<br>* 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)<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting glucose | change in fasting glucose measured by Huslab (laboratory measurement) | from gestational weeks 24-28 to gestational weeks 35-37 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fingertips fasting glucose values | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | 
| Fingertips postbrandial glucose values | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | 
| Fingertips area under the glucose curve | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | 
| Gestational weight | Measured with Seca Mod 8787041649 (scale) and registered from antenatal card | 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) | weight measured at 3 months postpartum | 
| Physical activity level | Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2 | 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. | at gestational weeks 24-28), 35-37 and at 3 months postpartum | 
| Neonatal body fat% | Measured with PEA POD Cosmed | 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. | at gestational weeks 24-28 and 35-37 | 
| Percentage of participants on metformin treatment | Percentage of participants need for metformin treatment | up to 42 gestational weeks | 
| Percentage of participants on insulin treatment | Percentage of participants need for insulin treatment | up to 42 gestational weeks | 
| Newborn birthweight and macrosomia | Newborn birth weight and macrosomia (birthweight >4kg) | one measure at birth | 
| Incidence of neonatal hypoglycemia | Percentage of neonatal hypoglycemia requiring intravenous glucose | within a week from birth | 
| Incidence of newborn large for gestational age | Percentage of newborn with birthweight percentile > + 2 SD | 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. | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | 
| 2-h OGTT | 2-hour blood glucose levels measured with OGTT (75g) | 3 months postpartum | 
| Stress levels | Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages. | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | 
| Costs | Costs of the intervention and treatment in healthcare. Defined as €/participant. | gestational weeks 24-28, 3 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, continuous glucose monitoring, physical activity, nutrition, behaviour change, stress, recovery, human-computer interaction, mobile application, self tracking