Usability Study of the Sensors and eMOM GDM Application

NCT03941652 | Active Not Recruiting

• 1 other identifier: HUS/2165/2018
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The principal aim of the eMOM GDM-project is to evaluate the effect of the eMOM GDM -application and the integrated service concept model on maternal and neonatal outcomes. In the first phase of the project the investigators evaluate the usability, functionality and acceptability of developed eMOM GDM application and used sensors (continuous glucose meter, accelerometer, speech-enabled food record, optical pulse, beat-to-beat heart rate). Two different user interfaces (one for the women with GDM and one for the health care professionals) of the eMOM GDM application will we be developed and evaluated.

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes; Continuous Glucose Values; Physical Activity; Nutrition; Behaviour Change; Stress; Recovery; Human-Computer Interaction (HCI); Mobile Application; Diet; Self-tracking; User interface; Health care professionals

Outcome Measures

Primary Outcomes (1)

• Basic version of the eMOM GDM application has developed

  Goal of the eMOM GDM -project is develop an application for gestational diabetes. The basic version of eMOM GDM application is ready to use in Phase 2 when in all sectors of Software Usability Measurement Inventory (SUMI) scale have mean of 50 or higher during the same development period (sprint). SUMI is a rigorously tested and proven method of measuring software quality from the end user's point of view. Sectors which SUMI measures are efficiency, affect, helpfulness, control, learnability, and global usability of software.

  1 week

Secondary Outcomes (7)

• Acceptability of sensors assessed by UTAUT questionnaire

  1 week

• Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire

  1 week

• Usability of sensors and their current applications

  1 week

• First impressions of a partially functional prototype of the eMOM GDM

  1 week

• Usability of eMOM GDM prototype application

  1 week

Other Outcomes (7)

• Continuous glucose levels dataset

  1 week

• Physical activity dataset

  1 week

• Sleep dataset

  1 week

Study Arms (4)

Women with gestational diabetes without a prior GDM

The investigators will evaluate the usability of the sensors and define what features the application should have and how the data should be presented to the users. Participants (n=up to 10) use the sensors for one week and fill out logbooks for physical activity, sleep and diet. Participants fill questionnaires before and after the usage period, and take part in semi-structured interview.

Women with gestational diabetes with or without a prior GDM

The investigators define major usability issues with different versions of functional prototypes of eMOM GDM application developed in the project before moving to phase 2 of the study. GDM women (n=up to 12) will use the available version of the application for one week, and afterward the participants with GDM will take part in semi-structured interview.

General pregnant women

The investigators will define major usability issues with different versions of functional prototypes of eMOM GDM application developed in the project before moving to phase 2 of the study. General pregnant women (n=up to 30) will use the available version of the application for one week, and afterward the general pregnant women will fill out a web form of usability of the application after the application week.

Health care professionals

Nurses/midwifes (n=up to 20) will be interviewed for collecting user requirements for the professional eMOM GDM application in semi-structured interviews.

Eligibility Criteria

• Age: 18 Years - 68 Years
• Gender Eligibility Details: GDM can be studied only in pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* General population of pregnant women * Pregnant women without gestational diabetes in previous pregnancy * Pregnant women with or without gestational diabetes in previous pregnancies * Health care professionals (nurses/midwives)

You may qualify if:

• General pregnant women at gestational week \>=24
• GDM women without a prior GDM at gestational week \>=24
• GDM women with or without a prior GDM at gestational week \>=24

You may not qualify if:

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus
• Use of medication that influences glucose metabolism in the beginning of the study (e.g. oral corticosteroids, metformin,insulin)
• Multiple Pregnancy
• Current substance abuse
• Severe psychiatric disorder
• Significant difficulty in cooperating (e.g. inadequate Finnish language skills)
• Significant physical disabilities
• For health care professionals
• \- Consult and treat women with GDM regularly
• \- Inadequate Finnish language skills

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Business Finland: collaborator
• Aalto University: collaborator
• University of Helsinki: collaborator
• Fujitsu Finland Oy: collaborator
• Elisa Oyj: collaborator
• CleverHealth Network: collaborator

Study Sites (1)

HUS

Helsinki, 00029, Finland

Location

Related Publications (2)

• Kyto M, Koivusalo S, Tuomonen H, Stromberg L, Ruonala A, Marttinen P, Heinonen S, Jacucci G. Supporting the Management of Gestational Diabetes Mellitus With Comprehensive Self-Tracking: Mixed Methods Study of Wearable Sensors. JMIR Diabetes. 2023 Oct 31;8:e43979. doi: 10.2196/43979.

  PMID: 37906216 DERIVED

• Kyto M, Koivusalo S, Ruonala A, Stromberg L, Tuomonen H, Heinonen S, Jacucci G. Behavior Change App for Self-management of Gestational Diabetes: Design and Evaluation of Desirable Features. JMIR Hum Factors. 2022 Oct 12;9(4):e36987. doi: 10.2196/36987.

  PMID: 36222806 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 Officials

• Seppo T Heinonen, prof

  Helsinki University Hospital, Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct prof, Obstetrician, Development Manager

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 8, 2019
• Study Start: May 27, 2019
• Primary Completion: October 30, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)