Usability Study of the Sensors and eMOM GDM Application

NCT ID: NCT03941652

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2026-12-30

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.

Detailed Description

The first phase of the eMOM GDM -project consists of two parts.

Phase 1.1. the usability of the sensors will be evaluated by asking participants with GDM diagnosis (n = up to 10) to use the sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Firstbeat Bodyguard 2, and Exced) and by collecting participants' blood glucose values from glucose meter (Contour Next ONE) for one week. Participants fill out a logbook for physical activity and sleeping for seven days, and a logbook for diet for three days during the study period. For ensuring the quality of food record a researcher will phone interview the participant based on her diet recordings.

Before starting using the sensors, the participants will fill Background questionnaire and Technology acceptance questionnaire (UTAUT). After the usage period, the participants will fill the same Technology acceptance questionnaire (UTAUT) and take part in semi-structured interview. The interview has to parts. In the first part, participants will be interviewed about the acceptability of sensors. In the second part, researcher will show a non-functional prototype of eMoM GDM application to the participant and will ask predetermined questions. Interview will be recorded and data obtained from the interviews will be transcribed for analysis.

Phase 1.2. 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 in total) and GDM women (n=up to 10) will use the available version of the application for one week, and afterward the participants with GDM will take part in semi-structured interview. Interview will be recorded and data will be transcribed for analysis. General pregnant women will fill out a web form of usability of the application after application week. Based on the responses of the form, the participants may be contacted for further inquiries about the usability issues they have reported. For ensuring the quality of food record a researcher will phone interview all participants based on her diet recordings.

In Phase 1.3 user requirements for the professional eMOM GDM application will be collected. The first aim of this evaluation is to define what features the application should have. These user requirements are collected with a semi-structured interview. Before the interview, background of the 15-20 nurses/midwifes is asked with background questionnaire on profession. In the interviews, the questions are predetermined, but some flexibility is allowed. Interviews will be recorded and data obtained from the interviews will be transcribed for analysis.

Conditions

Gestational Diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Consult and treat women with GDM regularly

Exclusion Criteria

• 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

• Inadequate Finnish language skills

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Business Finland

OTHER

Sponsor Role: collaborator

Aalto University

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Fujitsu Finland Oy

UNKNOWN

Sponsor Role: collaborator

Elisa Oyj

UNKNOWN

Sponsor Role: collaborator

CleverHealth Network

UNKNOWN

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Saila Koivusalo

Adjunct prof, Obstetrician, Development Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seppo T Heinonen, prof

Role: STUDY_DIRECTOR

Helsinki University Hospital, Women's Hospital

Locations

HUS

Helsinki, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 37906216 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36222806 (View on PubMed)

Other Identifiers

HUS/2165/2018

Identifier Type: -

Identifier Source: org_study_id