Diabetes Mellitus, Type 2NCT05883072
Exploring the Effectiveness of AI Generative Models for Diabetic Patients
An observational study of Diabetes Mellitus, Type 2 and Diabetic Retinopathy, run by Pakistan Council of Scientific and Industrial Research at 1 site in Pakistan.
Trial summary
We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Retinopathy, Diabetes
- What is being tested?
- Exploring AI-Chatbot
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2023to 31 Dec 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People affected with diabetes in Pakistan
Who may be able to join
- Present physically in Pakistan
- Adults (18 years or older)
- Diabetic Patient
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
CDLE, PCSIR Lbas Complex
Karachi, Sindh
Ghulam Mustafa, mustafabme@gmail.com
About this study
We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient
Read the detailed description
Diabetes is rapidly spreading, affecting a significant number of adults, with a staggering total of 537 million diabetic individuals. This condition gives rise to various complications that can lead to diabetic retinopathy, foot ulcers, cardiac problems, and kidney damage. However, many of these complications can be mitigated by providing patients with accurate information concerning their diet, stress management, and weight control.
The recent advancements in Generative Artificial Intelligence-based chatbots have demonstrated their efficacy as intelligent assistants across various aspects of human life. In this study, we aim to assess the effectiveness of these Language Models in assisting patients. Our research plan entails the interaction between patients and chatbots like ChatGPT, both with and without human support, followed by evaluations of these interactions by specialists. Additionally, we will gather feedback from patients regarding their experiences and perceptions of the chatbot interactions.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Retinopathy, Diabetes
- Being tested
- Exploring AI-Chatbot
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exploring AI-ChatbotBehavioural
All participants will be provided access to AI-Chatbot and will be asked to enquire their daily life problems related to diabetes. They will also be asked to review the replies of the Chatbot after their interaction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Patients will be provided access to Chatbot to enquire their querries regarding diabetic complications. Receives: Behavioral: Exploring AI-Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the Chatbot for diabetic patient
To assess the usability of the Chatbot, we will employ the mHealth App Usability Questionnaire (MAUQ) to gather feedback from patients following their interaction. Our study will utilize Table 4 of this questionnaire, which consists of three sections: ease of use, interface, and satisfaction and usefulness. Specifically, we will focus our evaluation on 10 out of the 18 questions presented in this table. The selected questions are S1, S2, S6, S7, S9, S11, S12, S13, S14, and S18. Patients will provide their responses on a scale of 1 to 5, where "1" indicates very poor and "5" denotes very good.
Measured: One time
Internet Speed
Minimum downloading speed of internet will be measured during the chat. This will be recorded in Mega bits per second.
Measured: One time
Secondary outcomes (1)
Analyzing Chat response generated by AI Chatbot
Likert scale will be used to evaluate the chat response of Chatbot. The following parameters will be evaluated by the specialists for each response namely Clear, Complete and Correct. Clear and Completeness will be evaluated on a range of 1-5, where 1 means poor quality and 5 means very good quality response.
The correctness of each response will be further analyzed as Safe and latest. It will be evaluated in binary terms i.e. Yes or No.
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start5 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Council of Scientific and Industrial Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghulam Mustafa, Principal investigator, Pakistan Council of Scientific and Industrial Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883072
- Sponsor's protocol ID
- AI Chatbot Evaluation
- Status last verified
- Jun 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of AI Generative Models for Diabetic Patients
- ClinicalTrials.gov ID
- NCT05883072
- Acronym / sponsor ID
- AI Chatbot Evaluation
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Retinopathy, Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pakistan Council of Scientific and Industrial ResearchUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 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.
We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient
Detailed description
Diabetes is rapidly spreading, affecting a significant number of adults, with a staggering total of 537 million diabetic individuals. This condition gives rise to various complications that can lead to diabetic retinopathy, foot ulcers, cardiac problems, and kidney damage. However, many of these complications can be mitigated by providing patients with accurate information concerning their diet, stress management, and weight control.
The recent advancements in Generative Artificial Intelligence-based chatbots have demonstrated their efficacy as intelligent assistants across various aspects of human life. In this study, we aim to assess the effectiveness of these Language Models in assisting patients. Our research plan entails the interaction between patients and chatbots like ChatGPT, both with and without human support, followed by evaluations of these interactions by specialists. Additionally, we will gather feedback from patients regarding their experiences and perceptions of the chatbot interactions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Exploring AI-ChatbotPatients will be provided access to Chatbot to enquire their querries regarding diabetic complications. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People affected with diabetes in Pakistan
Key inclusion criteria (3 listed)
- Present physically in Pakistan
- Adults (18 years or older)
- Diabetic Patient
Key exclusion criteria (3 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
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 |
|---|---|---|
| Exploring AI-ChatbotAll participants will be provided access to AI-Chatbot and will be asked to enquire their daily life problems related to diabetes. They will also be asked to review the replies of the Chatbot after their interaction. | Behavioural | Intervention |
Primary outcome
Usability of the Chatbot for diabetic patient
Time frame: One time
To assess the usability of the Chatbot, we will employ the mHealth App Usability Questionnaire (MAUQ) to gather feedback from patients following their interaction. Our study will utilize Table 4 of this questionnaire, which consists of three sections: ease of use, interface, and satisfaction and usefulness. Specifically, we will focus our evaluation on 10 out of the 18 questions presented in this table. The selected questions are S1, S2, S6, S7, S9, S11, S12, S13, S14, and S18. Patients will provide their responses on a scale of 1 to 5, where "1" indicates very poor and "5" denotes very good.
Internet Speed
Time frame: One time
Minimum downloading speed of internet will be measured during the chat. This will be recorded in Mega bits per second.
1 secondary outcome
Analyzing Chat response generated by AI Chatbot
Time frame: One time
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 5 Jun 2023.
- Individual participant dataSharing planned: Yes
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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.
Ghulam Mustafa principal investigator
Pakistan Council of Scientific and Industrial Research
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 and Diabetic Retinopathy, run by Pakistan Council of Scientific and Industrial Research at 1 site in Pakistan.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 Pakistan. 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?
Contact Ghulam Mustafa (+923322340395, mustafabme@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the Chatbot for diabetic patient (time frame: One time). 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 5 Jun 2023.