[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653571":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":71,"studyPopulation":22,"armGroups":72,"interventions":85,"overallOfficials":95,"centralContacts":99,"locations":22,"responsibleParty":109,"collaborators":22,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":22,"enrollmentInfo":121,"targetDuration":22,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":143,"whyStopped":22,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":22},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and 3-month follow-up",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,24],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":23},"Change in fasting glucose from baseline to 3 months",null,"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.",{"measure":25,"description":26,"timeFrame":27},"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.","3-month follow-up",[29,33,37,40,43,46,49,52,55,58],{"measure":30,"description":31,"timeFrame":32},"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.","Baseline to 3-month follow-up",{"measure":34,"description":35,"timeFrame":36},"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\u002FL. Values will be summarized separately for Weeks 1-4 and Weeks 11-12 and compared descriptively within and between randomized groups.","Weeks 1-4 and Weeks 11-12",{"measure":38,"description":39,"timeFrame":36},"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.",{"measure":41,"description":42,"timeFrame":36},"Percentage of CGM time in range","Time in range is the percentage of valid sensor glucose readings from 3.9 to 10.0 mmol\u002FL, 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.",{"measure":44,"description":45,"timeFrame":36},"Percentage of CGM time above range","Time above range is the percentage of valid sensor glucose readings greater than 10.0 mmol\u002FL within each planned CGM wear period. The possible range is 0% to 100%; a lower percentage indicates less exposure to hyperglycaemia. Values will be summarized separately for Weeks 1-4 and Weeks 11-12.",{"measure":47,"description":48,"timeFrame":36},"Percentage of CGM time below range","Time below range is the percentage of valid sensor glucose readings less than 3.9 mmol\u002FL within each planned CGM wear period. The possible range is 0% to 100%; a lower percentage indicates less exposure to hypoglycaemia. Values will be summarized separately for Weeks 1-4 and Weeks 11-12.",{"measure":50,"description":51,"timeFrame":36},"Number of CGM-detected hypoglycaemia episodes","A CGM-detected hypoglycaemia episode is defined as sensor glucose less than 3.9 mmol\u002FL for at least 15 consecutive minutes. The outcome is the number of episodes within each planned CGM wear period, reported as a count from 0 upward; a lower count indicates fewer hypoglycaemia episodes. Counts will be summarized separately for Weeks 1-4 and Weeks 11-12.",{"measure":53,"description":54,"timeFrame":36},"Total duration of CGM-detected hypoglycaemia episodes","For CGM-detected hypoglycaemia episodes defined as sensor glucose less than 3.9 mmol\u002FL for at least 15 consecutive minutes, the total duration of all qualifying episodes within each planned CGM wear period will be reported in minutes. The possible range is 0 minutes upward; a lower duration indicates less exposure to hypoglycaemia.",{"measure":56,"description":57,"timeFrame":36},"Number of CGM-detected hyperglycaemia episodes","A CGM-detected hyperglycaemia episode is defined as sensor glucose greater than 10.0 mmol\u002FL for at least 15 consecutive minutes. The outcome is the number of episodes within each planned CGM wear period, reported as a count from 0 upward; a lower count indicates fewer hyperglycaemia episodes. Counts will be summarized separately for Weeks 1-4 and Weeks 11-12.",{"measure":59,"description":60,"timeFrame":36},"Total duration of CGM-detected hyperglycaemia episodes","For CGM-detected hyperglycaemia episodes defined as sensor glucose greater than 10.0 mmol\u002FL for at least 15 consecutive minutes, the total duration of all qualifying episodes within each planned CGM wear period will be reported in minutes. The possible range is 0 minutes upward; a lower duration indicates less exposure to hyperglycaemia.",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":22,"timePerspective":22,"maskingInfo":66},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":67,"maskingDescription":68,"whoMasked":69},"SINGLE","Participants and intervention staff cannot be blinded because the intervention group receives access to the PIPE-AI app. Participants will be randomized in a 1:1 ratio using sequentially numbered, opaque, sealed envelopes prepared before recruitment according to a pre-generated randomization list. After eligibility confirmation, written informed consent, and baseline assessment, the next available envelope will be opened according to the study SOP to reveal the assigned group and follow-up instructions. The envelope system is used for allocation concealment before assignment and to reduce selection bias.",[70],"OUTCOMES_ASSESSOR","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.\n\nApproximately 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.\n\nRandomization 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.\n\nParticipants 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.\n\nParticipants 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.\n\nAll 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.\n\nParticipants 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.",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"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.",[78],"Behavioral: PIPE-AI digital patient empowerment intervention",{"label":80,"type":81,"description":82,"interventionNames":83},"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.",[84],"Other: Waitlist usual care control",[86,91],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":22},"BEHAVIORAL","PIPE-AI digital patient empowerment intervention","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.",[74],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":22},"Waitlist usual care control","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.",[80],[96],{"name":97,"affiliation":5,"role":98},"Lin Yang, Doctor","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":22,"email":104},"Shuya Lu","CONTACT","+86 18030800242","shuya.lu@connect.polyu.hk",{"name":106,"role":102,"phone":107,"phoneExt":22,"email":108},"Yang Lin, Doctor","+852 27666398","l.yang@polyu.edu.hk",{"type":110,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100653571","pilot-rct-of-pipe-ai-for-prediabetes-and-diabetes-self-management-100653571",false,"NCT07787403","Pilot RCT of PIPE-AI for Prediabetes and Diabetes Self-Management","A Personalized Interactive Patient Empowerment Artificial Intelligence Platform (PIPE-AI) Enhanced by DiabetesGPT in Prediabetes and Diabetes Patients in Primary Healthcare Settings","PIPE-AI","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with prediabetes or diabetes by their family doctors.\n* Able to understand Chinese.\n* Possess a mobile phone that can install the app developed for this project.\n\nExclusion Criteria:\n\n* Under legal guardianship.\n* Comorbid schizophrenia.\n* Intellectual disability.\n* Incompetent in giving consent.\n* Other significant cognitive disorders.","ALL","18 Years",{"count":122,"type":123},50,"ESTIMATED","INTERVENTIONAL",[126],"NA","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.",[129,130,131],"Prediabetes \u002F Type 2 Diabetes","Diabetes Mellitus, Type 2","Prediabetes",[117,133,131,134,135,136,137,138,139,140,141,142],"DiabetesGPT","Type 2 diabetes","Diabetes self-management","Patient empowerment","Digital health","Artificial intelligence","Continuous glucose monitoring","Primary healthcare","Hong Kong","Pilot randomized controlled trial","NOT_YET_RECRUITING","2026-08-21",{"date":146,"type":147},"2026-08-26","ACTUAL",{"date":149,"type":123},"2026-08-29",{"date":151,"type":123},"2026-11-29",{"name":5,"class":6}]