AI Chatbot Mobile App for Self-Management in Type 2 Diabetes (CHAT-T2DM)

November 3, 2026 updated by: Mohamed Fakhry Ahmed Salem, Alexandria University

Effect of an AI-Powered Chatbot-Integrated Mobile Application on Self-Efficacy, Self-Care Behaviors, and Medication Adherence Among Patients With Type 2 Diabetes Mellitus: A Mixed-Methods Randomized Controlled Trial

Type 2 diabetes needs daily self-management, but most of it happens outside the clinic, where patients get little continuous support. Earlier studies of mobile applications and chatbots were mostly short, and few tested whether benefits last after use stops. This randomized controlled trial will test an Arabic-language mobile application with an artificial intelligence chatbot for adults with type 2 diabetes attending outpatient diabetes clinics in Egypt. The application offers diabetes education, reminders, glucose and activity logging, goal setting, prompts that adapt when use declines, a diabetes distress check, and nurse oversight. A total of 120 adults will be randomly assigned equally to usual care plus the application for 8 weeks, or to usual care with an educational leaflet. Outcome assessors will not know group assignment. The main outcome is self-efficacy. Other outcomes are self-care behaviors, medication adherence, disease knowledge, random blood glucose, diabetes distress, and application use, measured at the start, at 8 weeks, and 6 and 12 weeks after the intervention ends. About 20 intervention participants will then be interviewed about their experiences and what helps or hinders continued use, and these findings will be combined with the trial results.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 2500
        • Faculty of Nursing, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years or older with a diagnosis of type 2 diabetes for at least 6 months
  • Using a smartphone (Android or iOS) with internet access, or willing to use a study-provided basic training to do so
  • Able to read and communicate in Arabic
  • On a stable antidiabetic regimen for at least 3 months
  • Willing to provide written informed consent

Exclusion Criteria:

  • Type 1 or gestational diabetes
  • Severe cognitive impairment, psychiatric illness, or visual/hearing impairment preventing app use
  • Acute diabetic complications or unstable medical conditions at enrollment
  • Participation in another diabetes self-management trial
  • Healthcare workers (to limit contamination)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI Chatbot App Plus Usual Care

Usual care (routine clinic follow-up and standard diabetes education) plus the AI chatbot-integrated mobile application for 8 weeks.
Behavioral: AI Chatbot-Integrated Mobile Application

Eight-week use of an Arabic-language mobile application with an AI conversational chatbot that answers diabetes questions and delivers structured education on diet, activity, glucose monitoring, medication use and foot care. Includes personalized medication and self-monitoring reminders; glucose and activity logging with feedback; goal setting, progress summaries and positive reinforcement; adaptive engagement prompts and content that change when usage declines; a diabetes distress screening module with escalation to the study nurse for flagged participants; and a nurse dashboard for monitoring usage and responding to safety alerts. The chatbot does not give insulin or drug dose changes and redirects urgent symptoms to emergency care. Participants receive app installation and a short orientation.
No Intervention: Usual Care With Educational Leaflet

Usual care (routine clinic follow-up and standard diabetes education) with an educational leaflet. Control participants will be offered the application after the final assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy for Diabetes Management
Time Frame: Baseline, week 8, week 14 and week 20

Self-efficacy in managing diabetes measured with the Diabetes Self-Efficacy Scale (validated Arabic version); higher scores indicate greater self-efficacy. Group comparison of change from baseline, adjusted for baseline score.
Baseline, week 8, week 14 and week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Care Behaviors
Time Frame: Baseline, week 8, week 14 and week 20

Summary of Diabetes Self-Care Activities (SDSCA), Arabic version; higher scores indicate more frequent self-care.
Baseline, week 8, week 14 and week 20
Change in Self-Reported Medication Adherence
Time Frame: Baseline, week 8, week 14 and week 20

Self-report medication adherence scale, Arabic version (instrument to be confirmed before data collection).
Baseline, week 8, week 14 and week 20
Change in Disease Knowledge
Time Frame: Baseline, week 8, week 14 and week 20

Diabetes Knowledge Questionnaire (DKQ-24), Arabic version; higher scores indicate greater knowledge.
Baseline, week 8, week 14 and week 20
Participant Experiences With the App
Time Frame: After the week 20 assessment

Semi-structured in-depth interviews on experiences, barriers and facilitators of continued use.
After the week 20 assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Mohamed Fakhry Ahmed Salem, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2026

Primary Completion (Estimated)

May 9, 2027

Study Completion (Estimated)

May 9, 2027

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AICHATBOT-T2DM-RCT-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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