Diabetes Mellitus, Type 2NCT04244110
Pilot for the Analysis of Usability in the Use of the Diacare Platform for People With Type 2 DM and Their Professionals
An observational study of Diabetes Mellitus, Type 2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2020to 24 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The selected participants will belong to a primary care center based at Hospitalet de Llobregat, Barcelona (Spain).
Who may be able to join
- People diagnosed with type 2 DM based on clinical criteria
- People who own a Smartphone and have competences in the use of technology
Who cannot join
- People that cannot go to the primary care center
- People with cognitive deterioration
- People with limitations in the practice of physical exercise
- People with a life expectancy lower than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diacare Project: Pilot for the Analysis of Usability in the Use of the Diacare Project for People With DM2 and Their Professionals
The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.
Read the detailed description
Type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. In order to achieve an optimum level of independence in their self care, it is essential that type 2 DM patients take responsibility for the situation and be actively involved in the control of their health. Technology can solve some of the current challenges of chronic diseases such as type 2 DM, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mHealth. In this context, the Diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 DM in a more personalized and individual way. The Diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. This research project wants to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. For this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the DIACARE platform for 3 months. The results of this pilot will be collected through qualitative and quantitative data through the DIACARE platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, self-management, mHealth
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Diacare platform
System Usability Scale (SUS) is a self-administered questionnaire to evaluate the usability of the developed tool.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start17 Jan 2020
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació TicSalut
- Responsible party
- Principal investigator, Rosa Mª Flores, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Rosa Flores, MD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244110
- Sponsor's protocol ID
- DIACARE
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diacare Project: Pilot for the Analysis of Usability in the Use of the Diacare Project for People With DM2 and Their Professionals
- ClinicalTrials.gov ID
- NCT04244110
- Acronym / sponsor ID
- DIACARE
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, self-management, mHealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Fundació TicSalut
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 28 Jan 2020 (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 objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.
Detailed description
Type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. In order to achieve an optimum level of independence in their self care, it is essential that type 2 DM patients take responsibility for the situation and be actively involved in the control of their health. Technology can solve some of the current challenges of chronic diseases such as type 2 DM, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mHealth. In this context, the Diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 DM in a more personalized and individual way. The Diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. This research project wants to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. For this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the DIACARE platform for 3 months. The results of this pilot will be collected through qualitative and quantitative data through the DIACARE platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The selected participants will belong to a primary care center based at Hospitalet de Llobregat, Barcelona (Spain).
Key inclusion criteria (2 listed)
- People diagnosed with type 2 DM based on clinical criteria
- People who own a Smartphone and have competences in the use of technology
Key exclusion criteria (4 listed)
- People that cannot go to the primary care center
- People with cognitive deterioration
- People with limitations in the practice of physical exercise
- People with a life expectancy lower than 6 months
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
Usability of the Diacare platform
Time frame: 3 months
System Usability Scale (SUS) is a self-administered questionnaire to evaluate the usability of the developed tool.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- 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.
Rosa Flores, MD principal investigator
Institut Català de la Salut
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 Diabetes Mellitus, Type 2, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jan 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability of the Diacare platform (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.