Prediabetes / Type 2 DiabetesPIPE-AINCT07787403
Pilot RCT of PIPE-AI for Prediabetes and Diabetes Self-Management
A study testing PIPE-AI digital patient empowerment intervention in people with Prediabetes / Type 2 Diabetes and Diabetes Mellitus, Type 2, run by The Hong Kong Polytechnic University.
Trial summary
This pilot randomized controlled trial evaluates the feasibility, effectiveness, and acceptance of the Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) enhanced by DiabetesGPT among adults with prediabetes or diabetes in Hong Kong primary healthcare settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes / Type 2 Diabetes, Diabetes Mellitus, Type 2, Prediabetes
- What is being tested?
- PIPE-AI digital patient empowerment intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2026to 29 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosed with prediabetes or diabetes by their family doctors.
- Able to understand Chinese.
- Possess a mobile phone that can install the app developed for this project.
Who cannot join
- Under legal guardianship.
- Comorbid schizophrenia.
- Intellectual disability.
- Incompetent in giving consent.
- Other significant cognitive disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) Enhanced by DiabetesGPT in Prediabetes and Diabetes Patients in Primary Healthcare Settings
This pilot randomized controlled trial evaluates the feasibility, effectiveness, and acceptance of the Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) enhanced by DiabetesGPT among adults with prediabetes or diabetes in Hong Kong primary healthcare settings. Participants will be randomized in a 1:1 ratio to an intervention group receiving PIPE-AI or to a waitlist control group receiving usual care during the first 3 months. Both groups will complete baseline and 3-month assessments, including patient-reported outcome measures, clinical outcomes, healthcare service utilization, and intermittent continuous glucose monitoring using Abbott FreeStyle Libre 2 Plus sensors.
Read the detailed description
This study is a pilot randomized controlled trial designed to assess the feasibility, effectiveness, and acceptance of the PIPE-AI platform enhanced by DiabetesGPT before broader implementation in primary healthcare settings. The PIPE-AI platform integrates individualized risk assessments and a locally fine-tuned large language model, DiabetesGPT, to generate personalized health advice and patient empowerment support for people with prediabetes or diabetes.
Approximately 50 participants will be recruited and randomized in a 1:1 ratio to the intervention group or waitlist control group. Eligibility will be assessed by nurses and doctors in participating primary healthcare settings. After written informed consent, trained research assistants will conduct baseline assessments, including demographic and socioeconomic data, lifestyle behaviours, medical history, current medications, patient-reported outcome measures, and venous blood sampling for fasting glucose and HbA1c.
Randomization will be performed before recruitment by a statistician using R software. After baseline assessment, participants will receive an opaque letter containing their assigned group and follow-up instructions. Research assistants involved in subject recruitment and baseline assessment will be blinded to grouping to reduce measurement bias where operationally feasible.
Participants in the intervention group will install the PIPE-AI app and receive instructions on how to use it. An individualized patient empowerment programme will be provided during the 3-month follow-up period. App login frequency will be monitored on the server, and reminders may be sent by SMS, WhatsApp, or WeChat if a participant does not log in within one week after recruitment or stops logging in for more than one month.
Participants in the control group will follow a waitlist approach. During the first 3 months, they will receive usual care, including group-based patient empowerment programmes where available through the District Health Centre, general guidance from the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings, or routine diabetes education and management services in their respective clinics. After the 3-month follow-up assessment, control group participants will be given access to the app.
All RCT participants in both groups will use Abbott FreeStyle Libre 2 Plus continuous glucose monitoring sensors intermittently during the 3-month trial. After successful enrolment and baseline assessments, participants receive two CGM sensors for use during Weeks 1-4. If CGM data are successfully collected in the study system, the research team will contact the participant near the end of the trial to collect a third CGM sensor for use during Weeks 11-12. CGM data will be downloaded or exported for research analysis using pseudonymized study IDs.
Participants in both groups will complete a 3-month follow-up assessment, including patient-reported outcome measures, clinical outcomes, healthcare service utilization, and CGM-related data where applicable. Main analysis will adopt an intention-to-treat principle, with per-protocol analysis as sensitivity analysis. As this is a pilot RCT, CGM analyses will be exploratory and will assess feasibility, adherence, completeness of CGM data collection, glycaemic profiles, and signal of change for future definitive trials.
- Being tested
- PIPE-AI digital patient empowerment intervention, Waitlist usual care control
- Keywords
- PIPE-AI, DiabetesGPT, Prediabetes, Type 2 diabetes, Diabetes self-management, Patient empowerment, Digital health, Artificial intelligence, Continuous glucose monitoring, Primary healthcare, Hong Kong, Pilot randomized controlled trial
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPE-AI digital patient empowerment interventionBehavioural
PIPE-AI is a personalized interactive patient empowerment artificial intelligence platform enhanced by DiabetesGPT. It integrates individualized risk assessment and a locally fine-tuned large language model to provide personalized health advice, diabetes self-management support, and patient empowerment during the 3-month follow-up period.
Waitlist usual care controlOther
Participants receive usual care during the first 3 months and are given access to the PIPE-AI app after completion of the 3-month follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| PIPE-AI Intervention Group | Experimental | Participants assigned to the intervention group will install and use the PIPE-AI app. Research assistants will provide detailed instructions on app use. An individualized patient empowerment programme will be provided during the 3-month follow-up period. App login frequency will be monitored, and reminders may be sent by SMS, WhatsApp, or WeChat when needed. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the control group. Receives: Behavioral: PIPE-AI digital patient empowerment intervention |
| Waitlist Control Group | Active comparator | Participants assigned to the waitlist control group will receive usual care during the first 3 months. Depending on recruitment source, usual care may include group-based patient empowerment programmes provided by the District Health Centre, general guidance from the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings, or routine diabetes education and management services in their respective clinics. After the 3-month follow-up assessment, control group participants will be given access to the PIPE-AI app. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the intervention group. Receives: Other: Waitlist usual care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetes Self-Management Questionnaire total score from baseline to 3 months
Diabetes self-management is assessed using the 16-item Diabetes Self-Management Questionnaire (DSMQ). After reverse scoring the applicable items, the DSMQ total score is transformed to a scale from 0 to 10 points; higher scores indicate better diabetes self-management. The reported outcome is the change score calculated as the 3-month total score minus the baseline total score, with a possible range from -10 to 10 points. A positive change indicates improvement.
Measured: Baseline and 3-month follow-up
Change in Michigan Diabetes Knowledge Test 2 general knowledge score from baseline to 3 months
Diabetes knowledge is assessed using the 14-item general knowledge section of the Michigan Diabetes Knowledge Test 2 (DKT2). Each correct answer receives 1 point and an incorrect or missing answer receives 0 points. The general knowledge score ranges from 0 to 14 points; higher scores indicate greater diabetes knowledge. The reported outcome is the change score calculated as the 3-month score minus the baseline score, with a possible range from -14 to 14 points. A positive change indicates improvement.
Measured: Baseline and 3-month follow-up
Secondary outcomes (3)
Change in HbA1c from baseline to 3 months
HbA1c will be tested by the study team or obtained through study procedures. The endpoint is the change in HbA1c from baseline to the 3-month follow-up, using the same unit at both time points.
Measured: Baseline and 3-month follow-up
Change in fasting glucose from baseline to 3 months
Measured: Baseline and 3-month follow-upFasting glucose will be measured by the study team or obtained through study procedures. The endpoint is the change in fasting glucose from baseline to the 3-month follow-up, using the same unit at both time points.
User satisfaction with the PIPE-AI programme
User satisfaction with the PIPE-AI programme will be assessed at follow-up using study questionnaires among participants with access to the intervention. Scores or item responses will be summarized descriptively according to the final questionnaire scoring rule.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start29 Aug 2026 (estimated)
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes / Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be performed before recruitment by a statistician. After baseline assessment, each participant will receive an opaque letter containing the assigned group and follow-up instructions. Research assistants involved in subject recruitment and baseline assessment will be blinded to group allocation to reduce measurement bias where operationally feasible. Participants cannot be blinded to PIPE-AI access.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Yang, Doctor, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787403
- Sponsor's protocol ID
- PIPE-AI-RCT
- Other IDs
- 22231421, HSEARS20240614004, CIRB-2024-566-4
- Acronym
- PIPE-AI
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) Enhanced by DiabetesGPT in Prediabetes and Diabetes Patients in Primary Healthcare Settings
- ClinicalTrials.gov ID
- NCT07787403
- Acronym / sponsor ID
- PIPE-AI / PIPE-AI-RCT
- Keywords
- PIPE-AI, DiabetesGPT, Prediabetes, Type 2 diabetes, Diabetes self-management, Patient empowerment, Digital health, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 29 Aug 2026 (estimated)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 26 Aug 2026 (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 pilot randomized controlled trial evaluates the feasibility, effectiveness, and acceptance of the Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) enhanced by DiabetesGPT among adults with prediabetes or diabetes in Hong Kong primary healthcare settings. Participants will be randomized in a 1:1 ratio to an intervention group receiving PIPE-AI or to a waitlist control group receiving usual care during the first 3 months. Both groups will complete baseline and 3-month assessments, including patient-reported outcome measures, clinical outcomes, healthcare service utilization, and intermittent continuous glucose monitoring using Abbott FreeStyle Libre 2 Plus sensors.
Detailed description
This study is a pilot randomized controlled trial designed to assess the feasibility, effectiveness, and acceptance of the PIPE-AI platform enhanced by DiabetesGPT before broader implementation in primary healthcare settings. The PIPE-AI platform integrates individualized risk assessments and a locally fine-tuned large language model, DiabetesGPT, to generate personalized health advice and patient empowerment support for people with prediabetes or diabetes.
Approximately 50 participants will be recruited and randomized in a 1:1 ratio to the intervention group or waitlist control group. Eligibility will be assessed by nurses and doctors in participating primary healthcare settings. After written informed consent, trained research assistants will conduct baseline assessments, including demographic and socioeconomic data, lifestyle behaviours, medical history, current medications, patient-reported outcome measures, and venous blood sampling for fasting glucose and HbA1c.
Randomization will be performed before recruitment by a statistician using R software. After baseline assessment, participants will receive an opaque letter containing their assigned group and follow-up instructions. Research assistants involved in subject recruitment and baseline assessment will be blinded to grouping to reduce measurement bias where operationally feasible.
Participants in the intervention group will install the PIPE-AI app and receive instructions on how to use it. An individualized patient empowerment programme will be provided during the 3-month follow-up period. App login frequency will be monitored on the server, and reminders may be sent by SMS, WhatsApp, or WeChat if a participant does not log in within one week after recruitment or stops logging in for more than one month.
Participants in the control group will follow a waitlist approach. During the first 3 months, they will receive usual care, including group-based patient empowerment programmes where available through the District Health Centre, general guidance from the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings, or routine diabetes education and management services in their respective clinics. After the 3-month follow-up assessment, control group participants will be given access to the app.
All RCT participants in both groups will use Abbott FreeStyle Libre 2 Plus continuous glucose monitoring sensors intermittently during the 3-month trial. After successful enrolment and baseline assessments, participants receive two CGM sensors for use during Weeks 1-4. If CGM data are successfully collected in the study system, the research team will contact the participant near the end of the trial to collect a third CGM sensor for use during Weeks 11-12. CGM data will be downloaded or exported for research analysis using pseudonymized study IDs.
Participants in both groups will complete a 3-month follow-up assessment, including patient-reported outcome measures, clinical outcomes, healthcare service utilization, and CGM-related data where applicable. Main analysis will adopt an intention-to-treat principle, with per-protocol analysis as sensitivity analysis. As this is a pilot RCT, CGM analyses will be exploratory and will assess feasibility, adherence, completeness of CGM data collection, glycaemic profiles, and signal of change for future definitive trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be performed before recruitment by a statistician. After baseline assessment, each participant will receive an opaque letter containing the assigned group and follow-up instructions. Research assistants involved in subject recruitment and baseline assessment will be blinded to group allocation to reduce measurement bias where operationally feasible. Participants cannot be blinded to PIPE-AI access.
| Arm | Type | Receives |
|---|---|---|
| PIPE-AI Intervention Group | Experimental | Behavioral: PIPE-AI digital patient empowerment interventionParticipants assigned to the intervention group will install and use the PIPE-AI app. Research assistants will provide detailed instructions on app use. An individualized patient empowerment programme will be provided during the 3-month follow-up period. App login frequency will be monitored, and reminders may be sent by SMS, WhatsApp, or WeChat when needed. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the control group. |
| Waitlist Control Group | Active comparator | Other: Waitlist usual care controlParticipants assigned to the waitlist control group will receive usual care during the first 3 months. Depending on recruitment source, usual care may include group-based patient empowerment programmes provided by the District Health Centre, general guidance from the Hong Kong Reference Framework for Diabetes Care for Adults in Primary Care Settings, or routine diabetes education and management services in their respective clinics. After the 3-month follow-up assessment, control group participants will be given access to the PIPE-AI app. Participants will also undergo the same baseline and 3-month assessments and intermittent CGM procedures as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Diagnosed with prediabetes or diabetes by their family doctors.
- Able to understand Chinese.
- Possess a mobile phone that can install the app developed for this project.
Key exclusion criteria (5 listed)
- Under legal guardianship.
- Comorbid schizophrenia.
- Intellectual disability.
- Incompetent in giving consent.
- Other significant cognitive disorders.
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 |
|---|---|---|
| PIPE-AI digital patient empowerment interventionPIPE-AI is a personalized interactive patient empowerment artificial intelligence platform enhanced by DiabetesGPT. It integrates individualized risk assessment and a locally fine-tuned large language model to provide personalized health advice, diabetes self-management support, and patient empowerment during the 3-month follow-up period. | Behavioural | PIPE-AI Intervention Group |
| Waitlist usual care controlParticipants receive usual care during the first 3 months and are given access to the PIPE-AI app after completion of the 3-month follow-up assessment. | Other | Waitlist Control Group |
Primary outcome
Change in Diabetes Self-Management Questionnaire total score from baseline to 3 months
Time frame: Baseline and 3-month follow-up
Diabetes self-management is assessed using the 16-item Diabetes Self-Management Questionnaire (DSMQ). After reverse scoring the applicable items, the DSMQ total score is transformed to a scale from 0 to 10 points; higher scores indicate better diabetes self-management. The reported outcome is the change score calculated as the 3-month total score minus the baseline total score, with a possible range from -10 to 10 points. A positive change indicates improvement.
Change in Michigan Diabetes Knowledge Test 2 general knowledge score from baseline to 3 months
Time frame: Baseline and 3-month follow-up
Diabetes knowledge is assessed using the 14-item general knowledge section of the Michigan Diabetes Knowledge Test 2 (DKT2). Each correct answer receives 1 point and an incorrect or missing answer receives 0 points. The general knowledge score ranges from 0 to 14 points; higher scores indicate greater diabetes knowledge. The reported outcome is the change score calculated as the 3-month score minus the baseline score, with a possible range from -14 to 14 points. A positive change indicates improvement.
3 secondary outcomes
Change in HbA1c from baseline to 3 months
Time frame: Baseline and 3-month follow-up
Change in fasting glucose from baseline to 3 months
Time frame: Baseline and 3-month follow-upFasting glucose will be measured by the study team or obtained through study procedures. The endpoint is the change in fasting glucose from baseline to the 3-month follow-up, using the same unit at both time points.
User satisfaction with the PIPE-AI programme
Time frame: 3-month follow-up
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lin Yang, Doctor principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing PIPE-AI digital patient empowerment intervention in people with Prediabetes / Type 2 Diabetes and Diabetes Mellitus, Type 2, run by The Hong Kong Polytechnic University.
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 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shuya Lu (+86 18030800242, shuya.lu@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Self-Management Questionnaire total score from baseline to 3 months (time frame: Baseline and 3-month follow-up). 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 26 Aug 2026.