Clinical trial NCT04714762: eHealth in Treatment of Gestational Diabetes (eMOMGDM)
Official title: eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Mobile Application
Keywords: gestational diabetes
continuous glucose monitoring
physical activity
nutrition
behaviour change
stress
recovery
human-computer interaction
mobile application
self tracking
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Aalto University
name: UKK Institute
name: Tampere University
name: Finnish Institute for Health and Welfare
name: Fujitsu
name: Elisa Oyj
name: Business Finland
First posted: 2021-01-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Change in fasting glucose
timeFrame: from gestational weeks 24-28 to gestational weeks 35-37
Secondary outcomes:
measure: Fingertips fasting glucose values
timeFrame: from gestational weeks 24-28 up to delivery
measure: Fingertips postbrandial glucose values
timeFrame: from gestational weeks 24-28 up to delivery
measure: Fingertips area under the glucose curve
timeFrame: from gestational weeks 24-28 up to delivery
measure: Gestational weight
timeFrame: weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery
measure: Postpartum weight
timeFrame: weight measured at 3 months postpartum
measure: Physical activity level
timeFrame: at gestational weeks 24-28, 35-37 and at 3 months postpartum
measure: Total diet
timeFrame: at gestational weeks 24-28), 35-37 and at 3 months postpartum
measure: Neonatal body fat%
timeFrame: one measure within 0-3 days after birth of the child
measure: Motivation to manage GDM
timeFrame: at gestational weeks 24-28 and 35-37
measure: Percentage of participants on metformin treatment
timeFrame: up to 42 gestational weeks
measure: Percentage of participants on insulin treatment
timeFrame: up to 42 gestational weeks
measure: Newborn birthweight and macrosomia
timeFrame: one measure at birth
measure: Incidence of neonatal hypoglycemia
timeFrame: within a week from birth
measure: Incidence of newborn large for gestational age
timeFrame: one measure at birth
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
measure: 2-h OGTT
timeFrame: 3 months postpartum
measure: Stress levels
timeFrame: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
measure: Costs
timeFrame: gestational weeks 24-28, 3 months postpartum
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
References:
citation: 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.