Gestational DiabeteseMOMGDMNCT04714762
eHealth in Treatment of Gestational Diabetes (eMOMGDM)
A study testing eMOM GDM application in people with Gestational Diabetes and Mobile Application, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Mobile Application
- What is being tested?
- eMOM GDM application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 10 Mar 2021to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- GDM diagnoses at 24-28 gestational weeks
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)
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.
Read the 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:
- 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
- Conditions
- Gestational Diabetes, Mobile Application
- Being tested
- eMOM GDM application
- Keywords
- gestational diabetes, continuous glucose monitoring, physical activity, nutrition, behaviour change, stress, recovery, human-computer interaction, mobile application, self tracking
- Medical subject headings
- Diabetes, Gestational, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMOM GDM applicationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention (eMOM GDM application) | Experimental | 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). Receives: Device: eMOM GDM application |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting glucose
change in fasting glucose measured by Huslab (laboratory measurement)
Measured: from gestational weeks 24-28 to gestational weeks 35-37
Secondary outcomes (18)
Fingertips fasting glucose values
Measured with Contour Next One
Measured: from gestational weeks 24-28 up to delivery
Fingertips postbrandial glucose values
Measured with Contour Next One
Measured: from gestational weeks 24-28 up to delivery
Fingertips area under the glucose curve
Measured with Contour Next One
Measured: from gestational weeks 24-28 up to delivery
Gestational weight
Measured with Seca Mod 8787041649 (scale) and registered from antenatal card
Measured: 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)
Measured: weight measured at 3 months postpartum
Physical activity level
Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2
Measured: 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.
Measured: at gestational weeks 24-28), 35-37 and at 3 months postpartum
Neonatal body fat%
Measured with PEA POD Cosmed
Measured: 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.
Measured: at gestational weeks 24-28 and 35-37
Percentage of participants on metformin treatment
Percentage of participants need for metformin treatment
Measured: up to 42 gestational weeks
Percentage of participants on insulin treatment
Percentage of participants need for insulin treatment
Measured: up to 42 gestational weeks
Newborn birthweight and macrosomia
Newborn birth weight and macrosomia (birthweight >4kg)
Measured: one measure at birth
Incidence of neonatal hypoglycemia
Percentage of neonatal hypoglycemia requiring intravenous glucose
Measured: within a week from birth
Incidence of newborn large for gestational age
Percentage of newborn with birthweight percentile > + 2 SD
Measured: 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.
Measured: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
2-h OGTT
2-hour blood glucose levels measured with OGTT (75g)
Measured: 3 months postpartum
Stress levels
Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages.
Measured: gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum
Costs
Costs of the intervention and treatment in healthcare. Defined as €/participant.
Measured: gestational weeks 24-28, 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start10 Mar 2021
- Primary completion12 Dec 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Aalto University, UKK Institute, Tampere University, Finnish Institute for Health and Welfare, Fujitsu, Elisa Oyj, Business Finland
- Responsible party
- Principal investigator, Saila Koivusalo, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714762
- Sponsor's protocol ID
- HUS/2165/2018-Phase 2
- Acronym
- eMOMGDM
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Maattanen S, Koivusalo S, Ylinen H, Heinonen S, Kyto M. The Effect of a Mobile App (eMOM) on Self-Discovery and Psychological Factors in Persons With Gestational Diabetes: Mixed Methods Study. JMIR Mhealth Uhealth. 2025 Jun 4;13:e60855. doi: 10.2196/60855.
PubMed 40466096Kyto 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.
PubMed 36344008