Gestational DiabeteseMOMGDMNCT03941652
Usability Study of the Sensors and eMOM GDM Application
An observational study of Gestational Diabetes, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 54 participants
- Where
- 1 siteFinland
- Study dates
- 27 May 2019to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 68 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
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- Significant difficulty in cooperating (e.g. inadequate Finnish language skills)
- Significant physical disabilities
- For health care professionals
- Inadequate Finnish language skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability Study of the Sensors and the eMOM GDM Application eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study
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.
Read the 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
- 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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (7)
Acceptability of sensors assessed by UTAUT questionnaire
The acceptability of the sensors (Medtronic Guardian Connect, Garmin Vivosmart 3, Firsbeat Bodyguard 2, UKK Exsed, Ascensia Contour Next One) will be assessed by UTAUT (Unified Theory of Acceptance and Use of Technology)-questionnaire. UTAUT-questionnaire will be common for each sensor, so UTAUT will not be conducted for each sensor separately. The answers applied quantitative way so investigators are able analyzed change of acceptability of sensors caused by the intervention. Results applied to development of the eMOM GDM application.
Measured: 1 week
Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire
The acceptability of the sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Ascensia Contour Next One, Speechgrinder Snackchat) and the eMOM GDM prototype application will be assessed by UTAUT (Unified Theory of Acceptance and Use of Technology) questionnaire. UTAUT questionnaire will be common for each sensor and the application, so UTAUT will not be conducted for each sensor separately. The answers applied quantitative way so investigators are able analyzed change of acceptability of sensors and application caused by the intervention. Results applied to development of the eMOM GDM application.
Measured: 1 week
Usability of sensors and their current applications
Semi-structured interview of usability of chosen sensors and their current applications (Medtronic Guardian Connect, Garmin Vivosmart 3, Firsbeat Bodyguard 2, UKK Exsed, Ascensia Contour Next One).
General questions related to the usability issues of sensors and their current applications.
Sensors specific questions relate to usage of specific sensor and features of its application.
The answers of participants give for investigators the guideline for development of eMOM GDM application. The answers itself won't be scaled, there isn't wrong or correct answers. Answers which repeat the most commonly in the interviews are the most common issues and they will have a higher priority in the guideline than answers which arises only in one interview.
Measured: 1 week
First impressions of a partially functional prototype of the eMOM GDM
First impressions of eMOM GDM application questions relate to usability and acceptability of the eMOM GDM application which is under the development.
The answers of participants give for investigators the guideline for development of eMOM GDM application. The answers itself won't be scaled, there isn't wrong or correct answers. Answers which repeat the most commonly in the interviews are the most common issues and they will have a higher priority in the guideline than answers which arises only in one interview.
Measured: 1 week
Usability of eMOM GDM prototype application
Usability of the eMOM GDM prototype application will be assessed with a semi-structured interview. The interview has general questions about the usability issues of sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Ascensia Contour Next One, Speechgrinder Snackchat) and the eMOM GDM prototype application, and tasks which the participants try to solve using the eMOM GDM prototype application. The answers used as the guideline for development of eMOM GDM application.
Measured: 1 week
Technical functionality of eMOM GDM application
Technical functionality of eMOM GDM application will be assessed by a web-based survey. The web-survey asks feedback from the eMOM GDM prototype application, and Garmin Vivosmart 3 bracelet, and there are 20 questions from Software Usability Measurement Inventory (SUMI) which the participant answers agree, disagree or not sure. This survey used as a guideline for development of eMOM GDM application. The answers tell how much major problems investigators still have in the eMOM GDM prototype application.
Measured: 1 week
User requirements for professional eMOM GDM application
User requirements will be collected through a semi-structured interviews. The interviews will be transcribed and a a framework analysis will be conducted to find the most important features. The answers used as the guideline for development of professional eMOM GDM application.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start27 May 2019
- Primary completion28 Feb 2026
- Study completion30 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.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Business Finland, Aalto University, University of Helsinki, Fujitsu Finland Oy, Elisa Oyj, CleverHealth Network
- Responsible party
- Principal investigator, Saila Koivusalo, Helsinki University Central Hospital
- Investigators
- Seppo T Heinonen, prof, Study director, Helsinki University Hospital, Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941652
- Sponsor's protocol ID
- HUS/2165/2018
- Acronym
- eMOMGDM
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37906216Kyto 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.
PubMed 36222806
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of the Sensors and the eMOM GDM Application eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study
- ClinicalTrials.gov ID
- NCT03941652
- Acronym / sponsor ID
- eMOMGDM / HUS/2165/2018
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Continuous Glucose Values, Physical Activity, Nutrition, Behaviour Change, Stress, Recovery, Human-Computer Interaction (HCI)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Business Finland, Aalto University, University of Helsinki, Fujitsu Finland Oy, Elisa Oyj, CleverHealth Network
- Study start
- 27 May 2019 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Basic version of the eMOM GDM application has developed
Time frame: 1 week
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.
7 secondary outcomes
Acceptability of sensors assessed by UTAUT questionnaire
Time frame: 1 week
Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire
Time frame: 1 week
Usability of sensors and their current applications
Time frame: 1 week
First impressions of a partially functional prototype of the eMOM GDM
Time frame: 1 week
Usability of eMOM GDM prototype application
Time frame: 1 week
Technical functionality of eMOM GDM application
Time frame: 1 week
User requirements for professional eMOM GDM application
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 37906216Kyto 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.
- Derived from this study: PubMed 36222806Kyto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seppo T Heinonen, prof study director
Helsinki University Hospital, Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic version of the eMOM GDM application has developed (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.