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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gestational Diabetes; Mobile Application
• Intervention / Treatment: Device: eMOM GDM application

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (eMOM GDM application); 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; 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)
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Tampere University; Aalto University; Finnish Institute for Health and Welfare; UKK Institute; Business Finland; Elisa Oyj; Fujitsu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): December 12, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; nutrition; recovery; stress; gestational diabetes; continuous glucose monitoring; mobile application; behaviour change; human-computer interaction; self tracking
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus
• Other Study ID Numbers: HUS/2165/2018-Phase 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Until 2032
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No