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Type 2 Diabetes MellitusDIALOGUE-DM2NCT07252193

Generative AI-Based Simulation for Diagnostic Communication in Type 2 Diabetes (DIALOGUE-DM2)

A study testing AI-Based Simulation Training (DIALOGUE-DM2) and Traditional Training in people with Type 2 Diabetes Mellitus and Medical Education, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial evaluates the effectiveness of a generative artificial intelligence (AI)-based simulation program in improving diagnostic communication skills among medical students. The study is conducted at the Faculty of Higher Studies Iztacala, National Autonomous University of Mexico (UNAM). Read more about this study

Who is it for?
Ages 18 to 29 yearsHealthy volunteers can take part
What is being tested?
AI-Based Simulation Training (DIALOGUE-DM2) and Traditional Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteMexico
Study dates
22 Sep 2025to 20 Dec 2025
Phase
Interventional
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 29 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Medical students currently enrolled in the Faculty of Medicine (Medical Surgeon Program), UNAM-FES Iztacala.
  • Age between 18 and 30 years.
  • Able to provide informed consent.
  • Willing to participate in all study phases (pre-test, intervention, post-test).

Who cannot join

  • Prior participation in the DIALOGUE pilot study.
  • Previous formal training in diagnostic communication beyond the standard medical curriculum.
  • Incomplete availability for scheduled sessions.
  • Refusal or inability to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Universidad Nacional Autónoma de México, Faculty of Higher Studies Iztacala (FES Iztacala)

    Tlalnepantla

Other trials in Mexico

About this study

Official title: Generative AI Simulation for Diagnostic Communication in Type 2 Diabetes: A Randomized Controlled Trial (DIALOGUE-DM2)

This randomized controlled trial evaluates the effectiveness of a generative artificial intelligence (AI)-based simulation program in improving diagnostic communication skills among medical students. The study is conducted at the Faculty of Higher Studies Iztacala, National Autonomous University of Mexico (UNAM).

A total of 120 medical students are randomized to either an intervention group using the DIALOGUE-DM2 AI simulation platform or a control group following traditional educational methods. Participants complete a pre-test, receive training according to group assignment, and then undergo a post-test evaluation.

Read more

The primary outcome is improvement in diagnostic communication skills, measured by standardized patient scenarios and validated rubrics. Secondary outcomes include self-reported confidence, communication domains, and inter-rater agreement between faculty evaluators and AI scoring.

This trial aims to provide high-quality evidence on the potential of generative AI to enhance communication training in medical education, specifically in the context of type 2 diabetes diagnosis.

Read the detailed description

This study builds on a prior pilot trial (published in 2024) that demonstrated the feasibility of using generative artificial intelligence (AI) to train medical students in diagnostic communication. The current trial extends that work with a randomized, blinded, controlled design and a larger sample size.

Design:

The study is a randomized, blinded, parallel-group, controlled trial conducted at the Faculty of Higher Studies Iztacala (FES Iztacala), UNAM. A total of 120 medical students are enrolled and randomized (1:1) into either the intervention group (AI-based simulation training) or the control group (traditional training with standardized patients and faculty feedback).

Intervention:

  • Intervention group: Students interact with the DIALOGUE-DM2 platform, which provides generative AI-driven simulated patients. They complete multiple diagnostic disclosure scenarios and receive immediate feedback on performance, based on standardized communication rubrics.
  • Control group: Students receive standard training, including lectures and supervised practice with peer role-play and faculty-guided feedback.

Assessments:

  • Pre-test: All students complete one standardized patient scenario with faculty and AI evaluation prior to intervention.
  • Training phase: Participants complete their assigned training (AI vs. standard).
  • Post-test: Students complete a standardized diagnostic disclosure scenario. Independent faculty evaluators (blinded to group assignment) and the AI platform score performance.

Outcomes:

  • Primary outcome: Change in diagnostic communication performance score from pre-test to post-test, measured by validated rubrics (Kalamazoo framework, MRS).
  • Secondary outcomes:
  • Student self-assessment of communication confidence.
  • Domain-specific improvements (information delivery, empathy, risk explanation, shared decision-making).
  • Agreement between human evaluators and AI scoring.

Ethics and Oversight:

The study has been reviewed and approved by the Research Ethics Committee of FES Iztacala, UNAM (Approval Number CE/FESI/042025/1915). Risks are minimal, as the intervention is educational and non-invasive.

Significance:

This is the first randomized controlled trial in Mexico to evaluate a generative AI-based simulation for diagnostic communication. Results will inform the integration of AI-driven training tools into medical education curricula and could contribute to scalable innovations in the training of healthcare professionals for chronic disease management, starting with type 2 diabetes.

Being tested
AI-Based Simulation Training (DIALOGUE-DM2), Traditional Training
Keywords
Generative AI, Simulation-Based Education, Medical Students, Diagnostic Communication Skills, Artificial Intelligence in Healthcare, DIALOGUE-DM2
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Based Simulation Training (DIALOGUE-DM2)Behavioural

    Medical students interact with the DIALOGUE-DM2 platform, a generative AI-based simulation system. The platform delivers virtual patient encounters focused on type 2 diabetes diagnostic disclosure. Students complete multiple simulated scenarios and receive immediate AI-generated feedback aligned with standardized communication rubrics (Kalamazoo, MRS). Training aims to enhance diagnostic communication skills prior to post-test evaluation.

  • Traditional TrainingBehavioural

    Medical students receive traditional training in diagnostic communication. This includes lectures, peer role-play, and faculty-supervised feedback sessions covering diagnostic disclosure in type 2 diabetes. The training duration and number of sessions are matched to the intervention group.

Study groups in NCT07252193
Study groupRoleWhat they receive
AI-Based Simulation Training (DIALOGUE-DM2)ExperimentalMedical students assigned to this arm will receive training using the DIALOGUE-DM2 platform, which provides generative AI-driven simulated patients. Participants will engage in multiple diagnostic disclosure scenarios focused on type 2 diabetes and receive immediate feedback generated by the AI system. Feedback is aligned with validated communication frameworks (Kalamazoo, MRS). Training is conducted over several sessions prior to the post-test evaluation.
Receives: Behavioral: AI-Based Simulation Training (DIALOGUE-DM2)
Traditional TrainingActive comparatorMedical students assigned to this arm will receive traditional communication skills training. This includes lectures, peer role-play, and faculty-supervised feedback sessions covering diagnostic disclosure in type 2 diabetes. Participants will complete the same number of training sessions as the intervention group before the post-test evaluation.
Receives: Behavioral: Traditional Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Diagnostic Communication Performance Score

    Improvement in diagnostic communication skills, measured using validated rubrics - the Kalamazoo Essential Elements Communication Checklist and the Medical Communication Rating Scale (MCRS) - applied to standardized patient scenarios. Independent blinded faculty evaluators and AI scoring will be used. Scores range from 0 to 100, with higher values indicating better diagnostic communication performance.

    Measured: Approximately 12 weeks (from pre-test to post-test per participant).

Secondary outcomes (4)

  1. Change in Student Self-Reported Confidence in Diagnostic Communication

    Change in students' self-reported confidence when disclosing a diagnosis of type 2 diabetes, measured through a structured questionnaire using a 5-point Likert scale (1 = very low confidence, 5 = very high confidence). Higher scores indicate greater self-perceived confidence in diagnostic communication.

    Measured: Approximately 12 weeks (from pre-test to post-test per participant).

  2. Change in Domain-Specific Diagnostic Communication Scores (Kalamazoo Framework and Medical Communication Rating Scale)

    Improvement in specific communication domains - information delivery, empathy, risk explanation, and shared decision-making - evaluated using the Kalamazoo Essential Elements Communication Checklist and the Medical Communication Rating Scale (MCRS). Each domain is scored from 0 to 100, with higher scores indicating better performance.

    Measured: Approximately 12 weeks (from pre-test to post-test per participant).

  3. Agreement Between Human Evaluators and AI Scoring

    Level of concordance between blinded human evaluators and AI-based scoring of diagnostic communication performance, assessed using Cohen's kappa coefficient (κ). Scores range from -1.0 to +1.0, where values closer to +1.0 indicate stronger agreement between evaluators.

    Measured: Assessed at post-test, approximately 12 weeks after baseline per participant.

  4. Student Satisfaction With the Assigned Training Method

    Satisfaction with the assigned training method (AI-based simulation vs. traditional training), measured using a structured 5-point Likert satisfaction survey (1 = very dissatisfied; 5 = very satisfied). Higher scores indicate greater satisfaction with the training method.

    Measured: Assessed immediately after completion of the post-test, approximately 12 weeks after baseline per participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start22 Sep 2025
  3. Primary completion18 Dec 2025
  4. Study completion20 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm randomized, blinded, controlled trial comparing AI-based simulation training with traditional training in medical students facing type 2 diabetes disclosure scenarios.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252193
Sponsor's protocol ID
UNAM-DIALOGUE-DM2-2025
Acronym
DIALOGUE-DM2
Status last verified
Dec 2025
First submitted
2 Oct 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) will be shared, including rubric-based performance scores from pre-test and post-test evaluations, self-reported confidence questionnaires, satisfaction survey responses, and AI versus human evaluator ratings. Demographic data (age, sex, academic year) will also be included in anonymized form. No personally identifiable information will be shared.

Publications

  • Suarez-Garcia RX, Chavez-Castaneda Q, Orrico-Perez R, Valencia-Marin S, Castaneda-Ramirez AE, Quinones-Lara E, Ramos-Cortes CA, Gaytan-Gomez AM, Cortes-Rodriguez J, Jarquin-Ramirez J, Aguilar-Marchand NG, Valdes-Hernandez G, Campos-Martinez TE, Vilches-Flores A, Leon-Cabrera S, Mendez-Cruz AR, Jay-Jimenez BO, Saldivar-Ceron HI. DIALOGUE: A Generative AI-Based Pre-Post Simulation Study to Enhance Diagnostic Communication in Medical Students Through Virtual Type 2 Diabetes Scenarios. Eur J Investig Health Psychol Educ. 2025 Aug 7;15(8):152. doi: 10.3390/ejihpe15080152.

    PubMed 40863274

Questions about this trial

What is this clinical trial studying?

A study testing AI-Based Simulation Training (DIALOGUE-DM2) and Traditional Training in people with Type 2 Diabetes Mellitus and Medical Education, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.

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 4 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 29 Dec 2025. 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 Mexico. 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?

Change in Diagnostic Communication Performance Score (time frame: Approximately 12 weeks (from pre-test to post-test per participant).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07252193, which also lists 1 linked publication.

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 29 Dec 2025.

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DIALOGUE-DM2 Clinical Trial NCT07252193 | AzTrials