Type 2 Diabetes Mellitus (T2DM)DIACOACH-AINCT07165730
Virtual Health Coaching With Artificial Intelligence for Glycemic Control in Type 2 Diabetes
A study testing Virtual Health Coaching with Artificial Intelligence (DIACOACH) and Standard Diabetes Education in people with Type 2 Diabetes Mellitus (T2DM), run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of a virtual health coaching program based on artificial intelligence (AI) in improving blood sugar control among people with type 2 diabetes in primary health care settings in Jeneponto and Bantaeng, Indonesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Virtual Health Coaching with Artificial Intelligence (DIACOACH) and Standard Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 Diabetes Mellitus for more than 3 months
- Age between 30 and 56 years
- Able to read and understand instructions
- Have access to a digital device (smartphone or similar)
- In stable clinical condition
Who cannot join
- Diagnosed with Type 1 Diabetes Mellitus
- Patients with severe complications (e.g., advanced nephropathy, retinopathy, cardiovascular disease)
- Patients currently undergoing other structured interventions
- Patients on long-term steroid therapy
- Patients without access to a digital device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Public Health Center of Bontomatene and Public Health Center of Binamu Kota
Makassar, South Sulawesi, 90245
Akbar Akbar, +6285299176008, akbar27021992@gmail.com
About this study
Official title: Effectiveness of Virtual Health Coaching Based on Artificial Intelligence to Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus
This study aims to evaluate the effectiveness of a virtual health coaching program based on artificial intelligence (AI) in improving blood sugar control among people with type 2 diabetes in primary health care settings in Jeneponto and Bantaeng, Indonesia. The intervention will be delivered through the DIACOACH application, which provides personalized coaching, lifestyle guidance, and self-care support. Participants will be randomly assigned to either the intervention group, receiving virtual health coaching for 12 weeks, or the control group, receiving standard diabetes education. Main outcomes include fasting blood sugar and HbA1c levels. Other outcomes include self-care adherence, dietary behavior, and quality of life. This trial seeks to provide evidence on whether AI-based virtual coaching is a practical and effective digital health solution to support diabetes self-management in community health settings with limited resources.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels due to impaired insulin production or insulin resistance. Globally, the prevalence of T2DM continues to rise, and in Indonesia the number of cases has surpassed 10 million, placing the country among the top seven worldwide for diabetes prevalence. Poor glycemic control leads to serious complications such as kidney disease, cardiovascular disorders, and neuropathy, which reduce patients' quality of life and increase health care costs. One of the main challenges in diabetes management is the low level of patient adherence to recommended lifestyle changes, including diet, physical activity, and regular monitoring. Patients often struggle to maintain long-term self-management because of limited access to continuous education, motivation, and personalized support in primary health care settings.
Digital health innovations, including virtual health coaching, have emerged as promising solutions to address these challenges. Virtual health coaching provides structured, ongoing support by using digital platforms to deliver education, reminders, and behavioral feedback. The integration of artificial intelligence (AI) into virtual coaching systems allows the intervention to be more adaptive and personalized, responding to the unique behaviors and needs of each participant. The DIACOACH application has been specifically developed to support diabetes self-management in Indonesia. It offers adaptive education modules, lifestyle modification reminders, diet and exercise monitoring, medication tracking, and a chatbot interface for personalized interaction. Early community service activities using DIACOACH have shown improvements in patient knowledge, motivation, and preliminary indicators of glycemic control such as fasting blood glucose and HbA1c levels. However, systematic research is required to evaluate its effectiveness in a controlled study, particularly in primary care contexts with limited resources.
This study is designed as a quasi-experimental trial with a non-equivalent control group design. Participants will be adults aged 30 to 56 years who have been diagnosed with T2DM for more than three months, are clinically stable, able to read, and have access to a smartphone or digital device. Individuals with type 1 diabetes, severe complications, ongoing steroid therapy, or those enrolled in other structured interventions will be excluded. Eligible participants will be recruited from primary health care centers (Puskesmas) in Jeneponto and Bantaeng, Indonesia. After baseline assessments, participants will be allocated to either the intervention group or the control group.
The intervention group will use the DIACOACH application for twelve weeks. Through this platform, participants will receive adaptive education tailored to their daily routines, reminders about diet and physical activity, and continuous encouragement to maintain self-care practices. The app integrates principles of Social Cognitive Theory and Self-Determination Theory to build self-efficacy and intrinsic motivation. The AI-based system provides feedback based on real-time data entered by participants, such as blood glucose values, diet logs, exercise activities, and medication adherence. The control group will continue with standard diabetes education typically offered at health centers, which usually consists of routine counseling sessions and printed health information.
Primary outcomes will include fasting blood glucose (FBG), HbA1c, and random blood glucose (RBG), measured at baseline and after the twelve-week intervention. Secondary outcomes will assess changes in dietary behavior, physical activity, adherence to self-care, satisfaction with the intervention, and overall quality of life. Data will be collected through laboratory tests, validated questionnaires, and digital records from the application. Quantitative data will be analyzed using appropriate statistical tests such as paired t-tests and analysis of variance to evaluate differences between groups and across time points. In addition, a qualitative component will be conducted by interviewing selected participants from the intervention group to explore their perceptions, experiences, barriers, and facilitators in using AI-based virtual coaching for diabetes self-management.
The study is expected to provide comprehensive evidence on the feasibility, acceptability, and effectiveness of AI-based virtual health coaching in primary health care. As a preliminary study, it will serve to validate the DIACOACH platform and assess its potential impact on clinical outcomes as well as patient engagement. If the intervention is found to be effective, it may offer a scalable and low-cost strategy to improve diabetes management in Indonesia, particularly in underserved and resource-constrained communities. Furthermore, this research could contribute to the integration of digital health innovations into the national primary health care system and support ongoing initiatives to reduce the burden of diabetes and its complications.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Virtual Health Coaching with Artificial Intelligence (DIACOACH), Standard Diabetes Education
- Keywords
- Virtual Health Coaching, Artificial Intelligence (AI), Glycemic Control
- 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.
Virtual Health Coaching with Artificial Intelligence (DIACOACH)Behavioural
Participants in the intervention group will receive a 12-week virtual health coaching program using the DIACOACH application. The program includes adaptive digital education on diet, physical activity, and medication adherence, personalized reminders, daily self-monitoring, and feedback powered by artificial intelligence. The intervention is designed to improve self-care adherence and glycemic control (FBG, HbA1c, RBG) among adults with type 2 diabetes mellitus in primary care settings.
Standard Diabetes EducationBehavioural
Participants in the control group will receive standard diabetes education usually provided in primary health care centers. This includes routine counseling sessions, printed educational materials, and general advice on diet, physical activity, and medication adherence, without the use of the DIACOACH application.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Health Coaching (DIACOACH) | Experimental | Participants in this group will receive a 12-week virtual health coaching program through the DIACOACH application. The app provides adaptive education, reminders, self-care monitoring, and AI-based personalized feedback to support glycemic control. Receives: Behavioral: Virtual Health Coaching with Artificial Intelligence (DIACOACH) |
| Standard Diabetes Education | Active comparator | Participants in this group will receive standard diabetes education provided by primary health care centers, including routine counseling sessions and printed health information. Receives: Behavioral: Standard Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose (FBG)
Change in fasting blood glucose (mg/dL) from baseline to post-intervention, measured using standardized laboratory methods
Measured: Baseline and 12 weeks after intervention
Glycated Hemoglobin (HbA1c)
Change in HbA1c (%) from baseline to post-intervention, measured using standardized laboratory methods.
Measured: Baseline and 12 weeks after intervention.
Secondary outcomes (3)
Self-care Adherence
Measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. Higher scores indicate better adherence
Measured: Baseline and 12 weeks after intervention.
Dietary Behavior
Changes in dietary behavior assessed using validated dietary recall questionnaires.
Measured: Baseline and 12 weeks after intervention.
Physical Activity
Measured using the International Physical Activity Questionnaire (IPAQ), reported in MET-minutes/week.
Measured: Baseline and 12 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a quasi-experimental design with a non-equivalent control group model. Participants will be assigned in parallel to either the intervention arm, receiving virtual health coaching through the DIACOACH application for 12 weeks, or the control arm, receiving standard diabetes education in primary health care settings. The study aims to evaluate changes in glycemic control and self-management behaviors between groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andina Setyawati, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165730
- Sponsor's protocol ID
- UNHAS-VHC-AI-2025
- Other IDs
- 02209/UN4.22/PT.01.03/2025
- Acronym
- DIACOACH-AI
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the plan to share individual participant data (IPD) has not yet been determined. The decision will depend on institutional policies, ethical approvals, and participant consent. Data may be shared in the future upon request, following anonymization and appropriate agreements.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Health Coaching Based on Artificial Intelligence to Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07165730
- Acronym / sponsor ID
- DIACOACH-AI / UNHAS-VHC-AI-2025
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Virtual Health Coaching, Artificial Intelligence (AI), Glycemic Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 10 Sep 2025 (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.
This study aims to evaluate the effectiveness of a virtual health coaching program based on artificial intelligence (AI) in improving blood sugar control among people with type 2 diabetes in primary health care settings in Jeneponto and Bantaeng, Indonesia. The intervention will be delivered through the DIACOACH application, which provides personalized coaching, lifestyle guidance, and self-care support. Participants will be randomly assigned to either the intervention group, receiving virtual health coaching for 12 weeks, or the control group, receiving standard diabetes education. Main outcomes include fasting blood sugar and HbA1c levels. Other outcomes include self-care adherence, dietary behavior, and quality of life. This trial seeks to provide evidence on whether AI-based virtual coaching is a practical and effective digital health solution to support diabetes self-management in community health settings with limited resources.
Detailed description
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels due to impaired insulin production or insulin resistance. Globally, the prevalence of T2DM continues to rise, and in Indonesia the number of cases has surpassed 10 million, placing the country among the top seven worldwide for diabetes prevalence. Poor glycemic control leads to serious complications such as kidney disease, cardiovascular disorders, and neuropathy, which reduce patients' quality of life and increase health care costs. One of the main challenges in diabetes management is the low level of patient adherence to recommended lifestyle changes, including diet, physical activity, and regular monitoring. Patients often struggle to maintain long-term self-management because of limited access to continuous education, motivation, and personalized support in primary health care settings.
Digital health innovations, including virtual health coaching, have emerged as promising solutions to address these challenges. Virtual health coaching provides structured, ongoing support by using digital platforms to deliver education, reminders, and behavioral feedback. The integration of artificial intelligence (AI) into virtual coaching systems allows the intervention to be more adaptive and personalized, responding to the unique behaviors and needs of each participant. The DIACOACH application has been specifically developed to support diabetes self-management in Indonesia. It offers adaptive education modules, lifestyle modification reminders, diet and exercise monitoring, medication tracking, and a chatbot interface for personalized interaction. Early community service activities using DIACOACH have shown improvements in patient knowledge, motivation, and preliminary indicators of glycemic control such as fasting blood glucose and HbA1c levels. However, systematic research is required to evaluate its effectiveness in a controlled study, particularly in primary care contexts with limited resources.
This study is designed as a quasi-experimental trial with a non-equivalent control group design. Participants will be adults aged 30 to 56 years who have been diagnosed with T2DM for more than three months, are clinically stable, able to read, and have access to a smartphone or digital device. Individuals with type 1 diabetes, severe complications, ongoing steroid therapy, or those enrolled in other structured interventions will be excluded. Eligible participants will be recruited from primary health care centers (Puskesmas) in Jeneponto and Bantaeng, Indonesia. After baseline assessments, participants will be allocated to either the intervention group or the control group.
The intervention group will use the DIACOACH application for twelve weeks. Through this platform, participants will receive adaptive education tailored to their daily routines, reminders about diet and physical activity, and continuous encouragement to maintain self-care practices. The app integrates principles of Social Cognitive Theory and Self-Determination Theory to build self-efficacy and intrinsic motivation. The AI-based system provides feedback based on real-time data entered by participants, such as blood glucose values, diet logs, exercise activities, and medication adherence. The control group will continue with standard diabetes education typically offered at health centers, which usually consists of routine counseling sessions and printed health information.
Primary outcomes will include fasting blood glucose (FBG), HbA1c, and random blood glucose (RBG), measured at baseline and after the twelve-week intervention. Secondary outcomes will assess changes in dietary behavior, physical activity, adherence to self-care, satisfaction with the intervention, and overall quality of life. Data will be collected through laboratory tests, validated questionnaires, and digital records from the application. Quantitative data will be analyzed using appropriate statistical tests such as paired t-tests and analysis of variance to evaluate differences between groups and across time points. In addition, a qualitative component will be conducted by interviewing selected participants from the intervention group to explore their perceptions, experiences, barriers, and facilitators in using AI-based virtual coaching for diabetes self-management.
The study is expected to provide comprehensive evidence on the feasibility, acceptability, and effectiveness of AI-based virtual health coaching in primary health care. As a preliminary study, it will serve to validate the DIACOACH platform and assess its potential impact on clinical outcomes as well as patient engagement. If the intervention is found to be effective, it may offer a scalable and low-cost strategy to improve diabetes management in Indonesia, particularly in underserved and resource-constrained communities. Furthermore, this research could contribute to the integration of digital health innovations into the national primary health care system and support ongoing initiatives to reduce the burden of diabetes and its complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a quasi-experimental design with a non-equivalent control group model. Participants will be assigned in parallel to either the intervention arm, receiving virtual health coaching through the DIACOACH application for 12 weeks, or the control arm, receiving standard diabetes education in primary health care settings. The study aims to evaluate changes in glycemic control and self-management behaviors between groups
| Arm | Type | Receives |
|---|---|---|
| Virtual Health Coaching (DIACOACH) | Experimental | Behavioral: Virtual Health Coaching with Artificial Intelligence (DIACOACH)Participants in this group will receive a 12-week virtual health coaching program through the DIACOACH application. The app provides adaptive education, reminders, self-care monitoring, and AI-based personalized feedback to support glycemic control. |
| Standard Diabetes Education | Active comparator | Behavioral: Standard Diabetes EducationParticipants in this group will receive standard diabetes education provided by primary health care centers, including routine counseling sessions and printed health information. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Type 2 Diabetes Mellitus for more than 3 months
- Age between 30 and 56 years
- Able to read and understand instructions
- Have access to a digital device (smartphone or similar)
- In stable clinical condition
Key exclusion criteria (5 listed)
- Diagnosed with Type 1 Diabetes Mellitus
- Patients with severe complications (e.g., advanced nephropathy, retinopathy, cardiovascular disease)
- Patients currently undergoing other structured interventions
- Patients on long-term steroid therapy
- Patients without access to a digital device
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 |
|---|---|---|
| Virtual Health Coaching with Artificial Intelligence (DIACOACH)Participants in the intervention group will receive a 12-week virtual health coaching program using the DIACOACH application. The program includes adaptive digital education on diet, physical activity, and medication adherence, personalized reminders, daily self-monitoring, and feedback powered by artificial intelligence. The intervention is designed to improve self-care adherence and glycemic control (FBG, HbA1c, RBG) among adults with type 2 diabetes mellitus in primary care settings. | Behavioural | Virtual Health Coaching (DIACOACH) |
| Standard Diabetes EducationParticipants in the control group will receive standard diabetes education usually provided in primary health care centers. This includes routine counseling sessions, printed educational materials, and general advice on diet, physical activity, and medication adherence, without the use of the DIACOACH application. | Behavioural | Standard Diabetes Education |
Primary outcome
Fasting Blood Glucose (FBG)
Time frame: Baseline and 12 weeks after intervention
Change in fasting blood glucose (mg/dL) from baseline to post-intervention, measured using standardized laboratory methods
Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks after intervention.
Change in HbA1c (%) from baseline to post-intervention, measured using standardized laboratory methods.
3 secondary outcomes
Self-care Adherence
Time frame: Baseline and 12 weeks after intervention.
Dietary Behavior
Time frame: Baseline and 12 weeks after intervention.
Physical Activity
Time frame: Baseline and 12 weeks after intervention.
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 10 Sep 2025.
- Individual participant dataSharing planned: Undecided. At this stage, the plan to share individual participant data (IPD) has not yet been determined. The decision will depend on institutional policies, ethical approvals, and participant consent. Data may be shared in the future upon request, following anonymization and appropriate agreements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Health Coaching with Artificial Intelligence (DIACOACH) and Standard Diabetes Education in people with Type 2 Diabetes Mellitus (T2DM), run by Hasanuddin University at 1 site in Indonesia.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 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 Indonesia. 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 Nuurhidayat Jafar, Dr (+6281355576066, nuurhidayat@unhas.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (FBG) (time frame: Baseline and 12 weeks after intervention). 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 10 Sep 2025.