eHealth in Treatment of Gestational Diabetes (eMOMGDM)

NCT04714762 | Active Not Recruiting DMC

• 1 other identifier: HUS/2165/2018-Phase 2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in fasting glucose

  change in fasting glucose measured by Huslab (laboratory measurement)

  from gestational weeks 24-28 to gestational weeks 35-37

Secondary Outcomes (18)

• Fingertips fasting glucose values

  from gestational weeks 24-28 up to delivery

• Fingertips postbrandial glucose values

  from gestational weeks 24-28 up to delivery

• Fingertips area under the glucose curve

  from gestational weeks 24-28 up to delivery

• 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

• Postpartum weight

  weight measured at 3 months postpartum

Study Arms (2)

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).

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.

Interventions

eMOM GDM application DEVICE

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)

Intervention (eMOM GDM application)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only women have GDM
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• GDM diagnoses at 24-28 gestational weeks

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Related Publications (2)

• 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.

  PMID: 40466096 DERIVED

• 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.

  PMID: 36344008 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be anonomized (ID coded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Adjunct prof

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 19, 2021
• Study Start: March 10, 2021
• Primary Completion: December 12, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Until 2032

Locations

FI (1)