Pilot RCT of PIPE-AI for Prediabetes and Diabetes Self-Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Under legal guardianship.
Comorbid schizophrenia.
Intellectual disability.
Incompetent in giving consent.
Trial design
Design model
Parallel
Treatments tested in this trial
PIPE-AI digital patient empowerment intervention
BehavioralPIPE-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 control
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PIPE-AI Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 3-month follow-up2
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.
Time frame
Baseline and 3-month follow-upSecondary outcomes
1
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.
Time frame
Baseline and 3-month follow-up2
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.3
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.
Time frame
3-month follow-upOther outcomes
1
Incidence of adverse events
Adverse events will be recorded during the trial and summarized as the number and proportion of participants reporting any adverse event. CGM-related discomforts, skin reactions, sensor issues, and other device-related problems will be summarized separately when applicable.
Time frame
Baseline to 3-month follow-up2
Mean sensor glucose during planned CGM wear periods
Mean sensor glucose will be calculated as the arithmetic mean of all valid Abbott FreeStyle Libre 2 Plus sensor glucose readings within each planned wear period and reported in mmol/L. Values will be summarized separately for Weeks 1-4 and Weeks 11-12 and compared descriptively within and between randomized groups.
Time frame
Weeks 1-4 and Weeks 11-123
Glucose coefficient of variation during planned CGM wear periods
Glucose variability will be reported as the coefficient of variation, calculated as 100 multiplied by the standard deviation of valid sensor glucose readings divided by mean sensor glucose within each planned wear period. The unit is percent; lower values indicate less glucose variability. Values will be summarized separately for Weeks 1-4 and Weeks 11-12.
Time frame
Weeks 1-4 and Weeks 11-124
Percentage of CGM time in range
Time in range is the percentage of valid sensor glucose readings from 3.9 to 10.0 mmol/L, inclusive, within each planned CGM wear period. The possible range is 0% to 100%; a higher percentage indicates more time within the target glucose range. Values will be summarized separately for Weeks 1-4 and Weeks 11-12.
Time frame
Weeks 1-4 and Weeks 11-12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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