DiabetesAINCT06079450
Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant
An observational study of Diabetes, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted experimentally to examine the effect of artificial intelligence-based mobile virtual assistant developed for individuals with diabetes on cost, hospitalization rate, self-care and hypoglycemia. Methods: The research is multi-stage and designed as three stages in itself. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Diabetes
- What is being tested?
- artificial intelligence based mobile application
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 7 Aug 2023
- How long will I take part?
- 12 Months
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * The patient has a perception disorder and psychiatric disorder that prevents communication, * Desire to leave the research, * His death during the research, * Being pregnant, * Individuals with severe retinopathy and neuropathy that prevent smartphone use were excluded from the study.
Who may be able to join
- Having been diagnosed with Type 1 and Type 2 diabetes at least six months ago, according to the criteria of the American Diabetes Association (ADA),
- Using insulin for at least six months,
- Being between the ages of 18- 65,
- Being able to read and write and speak Turkish,
- Having an Android phone and being able to use mobile applications,
- To volunteer to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant Developed For Indıvıduals Wıth Dıabetes On Cost Effıcıency, Hospıtal Admıssıon Rate, Self-Care And Hypoglycemıa
Aim: This study was conducted experimentally to examine the effect of artificial intelligence-based mobile virtual assistant developed for individuals with diabetes on cost, hospitalization rate, self-care and hypoglycemia.
Methods: The research is multi-stage and designed as three stages in itself. According to this; development of the mobile application in the first and second stages and adding artificial intelligence to the application as a project; In the third stage, it was planned to examine the effect of the application on the variables and scales. The data of the study were collected between June 2022 and June 2023 in the Endocrinology Polyclinic of two private hospitals in Izmir and a diabetes association where individuals with diabetes were registered. Power 0.80 was determined by using NCSS PAS statistical software from the population of the research; The minimum number of samples to be included in the study was calculated as n:122 and they were divided into two as intervention and control groups by randomization. The research sample was carried out as intervention (n:60) and control (n:60) lastly due to death and cost. Five data collection tools were used, namely "Individual Introduction Form", "Diabetes Self-Care Scale", "Hypoglycemia Confidence Scale", "Mobile Application Opinion Form" and "Cost Table". An artificial intelligence-based mobile virtual assistant application was applied to the individuals with diabetes in the intervention group, and the data were collected three times, at the 0th, 6th and 12th months, and the costs were recorded. The standard outpatient trainings, which are currently applied, continued to be given to individuals with diabetes in the control group, the data were collected twice, at the beginning (0. month) and 12. months, and the costs were recorded. In the evaluation of the data, number, percentage, arithmetic mean, standard deviation, minimum and maximum median were calculated. Among the variables, chi-square, Kruskal Wallis, Mann Whitney U test and t test were used.
- Conditions
- Diabetes
- Being tested
- artificial intelligence based mobile application
- Keywords
- Diabetes, mobile application, artificial intelligence, self-care, hospitalization, cost
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence based mobile applicationOther
Artificial intelligence-based mobile application developed by me that includes diabetes education for individuals with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Artificial intelligence-based mobile application initiative was implemented for diabetes patients Receives: Other: artificial intelligence based mobile application | |
| control group | no intervention was applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Self-Care Scale
The score consists of 35 items and is a 4-point Likert type, the lowest acceptable score is 92 and the highest score is 140. As the score increases, self-care increases
Measured: 12 months
Hypoglycemic Confidence Scale
The scale consists of 9 items and is a 4-point Likert type. There is no cut-off value, the average score is used.
Measured: 12 months
Secondary outcomes (1)
hospitalization rate
percentage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Jun 2022
- Primary completion10 Jan 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökşen POLAT, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079450
- Sponsor's protocol ID
- IKCU
- Acronym
- AI
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant Developed For Indıvıduals Wıth Dıabetes On Cost Effıcıency, Hospıtal Admıssıon Rate, Self-Care And Hypoglycemıa
- ClinicalTrials.gov ID
- NCT06079450
- Acronym / sponsor ID
- AI / IKCU
- Conditions
- Diabetes
- Keywords
- Diabetes, mobile application, artificial intelligence, self-care, hospitalization, cost
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 12 Oct 2023 (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.
Aim: This study was conducted experimentally to examine the effect of artificial intelligence-based mobile virtual assistant developed for individuals with diabetes on cost, hospitalization rate, self-care and hypoglycemia.
Methods: The research is multi-stage and designed as three stages in itself. According to this; development of the mobile application in the first and second stages and adding artificial intelligence to the application as a project; In the third stage, it was planned to examine the effect of the application on the variables and scales. The data of the study were collected between June 2022 and June 2023 in the Endocrinology Polyclinic of two private hospitals in Izmir and a diabetes association where individuals with diabetes were registered. Power 0.80 was determined by using NCSS PAS statistical software from the population of the research; The minimum number of samples to be included in the study was calculated as n:122 and they were divided into two as intervention and control groups by randomization. The research sample was carried out as intervention (n:60) and control (n:60) lastly due to death and cost. Five data collection tools were used, namely "Individual Introduction Form", "Diabetes Self-Care Scale", "Hypoglycemia Confidence Scale", "Mobile Application Opinion Form" and "Cost Table". An artificial intelligence-based mobile virtual assistant application was applied to the individuals with diabetes in the intervention group, and the data were collected three times, at the 0th, 6th and 12th months, and the costs were recorded. The standard outpatient trainings, which are currently applied, continued to be given to individuals with diabetes in the control group, the data were collected twice, at the beginning (0. month) and 12. months, and the costs were recorded. In the evaluation of the data, number, percentage, arithmetic mean, standard deviation, minimum and maximum median were calculated. Among the variables, chi-square, Kruskal Wallis, Mann Whitney U test and t test were used.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: artificial intelligence based mobile applicationArtificial intelligence-based mobile application initiative was implemented for diabetes patients |
| control group | – | –no intervention was applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * The patient has a perception disorder and psychiatric disorder that prevents communication, * Desire to leave the research, * His death during the research, * Being pregnant, * Individuals with severe retinopathy and neuropathy that prevent smartphone use were excluded from the study.
Key inclusion criteria (6 listed)
- Having been diagnosed with Type 1 and Type 2 diabetes at least six months ago, according to the criteria of the American Diabetes Association (ADA),
- Using insulin for at least six months,
- Being between the ages of 18- 65,
- Being able to read and write and speak Turkish,
- Having an Android phone and being able to use mobile applications,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| artificial intelligence based mobile applicationArtificial intelligence-based mobile application developed by me that includes diabetes education for individuals with diabetes. | Other | experimental group |
Primary outcome
Diabetes Self-Care Scale
Time frame: 12 months
The score consists of 35 items and is a 4-point Likert type, the lowest acceptable score is 92 and the highest score is 140. As the score increases, self-care increases
Hypoglycemic Confidence Scale
Time frame: 12 months
The scale consists of 9 items and is a 4-point Likert type. There is no cut-off value, the average score is used.
1 secondary outcome
hospitalization rate
Time frame: 12 months
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 12 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 0 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 12 Oct 2023. 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 Turkey (Türkiye). 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?
Diabetes Self-Care Scale (time frame: 12 months). The study lists 2 primary outcomes in all. 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 12 Oct 2023.