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NCT Number: NCT05883072

Exploring the Effectiveness of AI Generative Models for Diabetic Patients

We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CDLE, PCSIR Lbas Complex

Karachi, Sindh, Pakistan

Location status: Recruiting

Location contact

Ghulam Mustafa

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Present physically in Pakistan
  • Adults (18 years or older)
  • Diabetic Patient

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners

Treatment and study plan

Exploring AI-Chatbot

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Analyzing Chat response generated by AI Chatbot

    Time frame: One time

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghulam Mustafa

CONTACT

[email protected]

+923322340395

Sponsors and collaborators

Lead sponsor

Pakistan Council of Scientific and Industrial Research

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
May 31, 2023
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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