ClinicalTrials.gg
Active, not recruitingNCT07835061AI-CIMCareUpdated Sep 22, 2026

AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM)

An interventional study of AI-CIMCare Chatbot and Empowerment Application for CAM Health Education in Diabetes, sponsored by Chang Gung University of Science and Technology. Active, not recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Chang Gung University of Science and Technology · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

Study summary

Performance analysis of the AI-CIMCare Chatbot is an essential way to ensure its impact on the promotion of patient-based outcomes in patients with diabetes.

Read the detailed description

A randomized controlled trial is to determine a cause-effect relation which exists between the intervention and the outcomes by avoiding contamination across individuals (Polit \& Beck, 2022). The chatbot for patients with diabetes in the management of CIM use alongside conventional diabetes treatment will be trained well at the end of the phase II study. The objectives of this phase are to (1) implement the chatbot to empower patients with diabetes in their management of diabetes alongside CAM use, (2) examine the impact of the chatbot on CIM health literacy, patient empowerment, user engagement, clinical outcomes and facilitate communication with HCPs in patients with diabetes, and (3) collect feedback from patients on how to improve the chatbot for dissemination and implementation.

02

Conditions studied

  • Diabetes

Keywords

  • Complementary and Integrative Medicine (CIM)
  • Patient Education
  • Empowerment
  • Health Literacy
  • Application
  • Diabetes
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 113 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chang Gung University of Science and Technology is the lead sponsor of 43 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • People over the age of 20
  • diagnosis of diabetes at least 12 months before the interview; and
  • The use of CAM at least 3 months
  • Sufficient mental ability to understand the form and sign it.

Exclusion criteria

Exclusion Criteria:

  • Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
113 participants (estimated)

Study arms

  • Experimental
    Intervention 1

    AI-CIMCare Chatbot plus Empowerment Application for CAM Health Education

    Behavioral: AI-CIMCare Chatbot · Behavioral: Empowerment Application for CAM Health Education

  • Active comparator
    Intervention 2

    Empowerment Application for CAM Health Education

    Behavioral: Empowerment Application for CAM Health Education

Interventions

  • BehavioralAI-CIMCare Chatbot

    The intervention will be carried out over a 12-week period, which contains four sections: (1) knowledge on benefit-risk assessment of CIM use; (2) short videos regarding information and skills necessary to seek, assess; (3) evaluate how to be critical for wise and safe use of CIM; and (4) linkage of government websites and the decision-making algorithm on the Benefit-Risk Assessment of CIM Use for People with Diabetes.

    Also known as: Empowerment Application for CAM

  • BehavioralEmpowerment Application for CAM Health Education

    Using empowerment software application for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of assistive tool of the empowerment software application

06

What researchers measure

Primary outcomes

  1. Understanding the benefits and risks of complementary therapies (CTs) use scale

    The 15-item scale assesses patients' awareness of CIM use in diabetes. The maximum score is 4 points, and the minimum score is 1 point for each item. Scores range from 15-60, with higher scores indicating greater understanding.

    Time frame: Pre-test (baseline),4,8,12 weeks after intervention

Secondary outcomes

  1. Patient empowerment

    The 10-item Diabetes Empowerment Scale assesses patients' perceived control and readiness for diabetes self-management. Maximum score is 4 points, minimum score is 1 point for each item. Scores range from 10-50, with higher scores indicating greater empowerment. The scale showed acceptable reliability (α = .77) and established construct and criterion validity.

    Time frame: Pre-test (baseline),4,8,12 weeks after intervention

  2. System Usability Scale (SUS)

    The 10-item questionnaire measures how easy a product, system, or website is to use. The maximum score is 5 points, and the minimum is 1 point per item. Scores range from 10-50, with higher scores indicating greater usability.

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  3. Quality of life

    The 15-item quality-of-life measure for Chinese patients with diabetes will be used to assess their life satisfaction. The maximum score is 5 points, and the minimum score is 1 point. Scores range from 15-75, with higher scores indicating greater life satisfaction.

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  4. Patient-HCP Communication

    The 10-item Details of CIM Use Survey, designed by Chang et al. (2011) with good content validity, assesses patterns of CIM use, experiences of CIM use, and disclosure of CIM use to HCPs.

    Time frame: Pre-test (baseline) and 12 weeks after intervention

Other outcomes

  1. Glycated Hemoglobin blood test

    It measures the average blood sugar levels over the past two to three months. Unit of Measurement: Percentage (%).

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  2. Fasting Plasma Glucose blood test

    A patient has fasted (no food or drink except water) for at least 8 hours to measure baseline blood sugar levels. Unit of Measurement: mg/dL (milligrams per deciliter)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  3. Cholesterol blood test

    It measures the weight of cholesterol in milligrams per deciliter of blood. Unit of Measurement: Unit of Measurement: mg/dL (milligrams per deciliter)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  4. Triglycerides blood test

    It measures serum or plasma triglyceride concentration. Unit of Measurement: mg/dL (milligrams per deciliter)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  5. Aspartate aminotransferase (AST) blood test

    It helps determine liver function. Unit of Measurement: units per liter (U/L).

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  6. Alanine aminotransferase (ALT) blood test

    It helps determine liver function. Unit of Measurement: units per liter (U/L).

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  7. Blood urea nitrogen (BUN) blood test

    It measures kidney filtration of protein waste. Unit of Measurement: milligrams per deciliter (mg/dL)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  8. Creatinine (Cr) blood test

    It measures how well the kidneys. Unit of Measurement: mg/dL (milligrams per deciliter)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  9. estimated GFR (eGFR) test

    It measures the volume of blood (in milliliters) filtered by the kidneys each minute. Unit of Measurement: milliliters per minute adjusted for body surface area mL/min/1.73m²

    Time frame: Pre-test (baseline) and 12 weeks after intervention

  10. Albumin-to-Creatinine Ratio (ACR) Urinalysis

    It is reported in milligrams per millimole (mg/mmol) or milligrams per gram (mg/g)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 11 months after the start.

Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 11 months is below that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2026
First posted
Sep 22, 2026
StartActual
Aug 5, 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07835061
Lead sponsor
Chang Gung University of Science and Technology
Collaborators
National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital, Taoyuan General Hospital
Responsible party
Hsiao-Yun Chang (professor, Chang Gung University of Science and Technology) — Principal investigator
First posted
Sep 22, 2026
Start date
Aug 5, 2026
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Chang Hsiao Yun, PhD
study chair · Chang Gung University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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