DiabetesNCT06693934
Jockey Club Precision Prevention Programme on Young Onset Diabetes
A study testing Risk assessment with biogenetic and clinical test to predict diabetes risk, Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors and Medication in people with Diabetes and Pre Diabetes, run by Juliana CN Chan at 1 site in Hong Kong.
Trial summary
This is a community-based implementation program consisting of multiple components delivered by a multidisciplinary team to detect and prevent young onset diabetes with precision and value using biogenetic markers, digital tools, integrated care through public private partnership. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Pre Diabetes, Hypertension
- What is being tested?
- Risk assessment with biogenetic and clinical test to predict diabetes risk, Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors and Medication
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Nov 2024to May 2028
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 44 years old
- With at least one risk factor for diabetes
Who cannot join
- Known history of Diabetes
- With conditions considered not suitable by the project team (including illiteracy)
- The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension/ high blood glucose level/ abnormal lipid level/ vascular disease/ fatty liver, history of gestational diabetes/ polycystic ovary syndrome/ delivery of baby≥ 4kg (for women only), and less than 150mins of physical activity every week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Asia Diabetes Foundation
Hong Kong
Amy Fu, MPH
About this study
This is a community-based implementation program consisting of multiple components delivered by a multidisciplinary team to detect and prevent young onset diabetes with precision and value using biogenetic markers, digital tools, integrated care through public private partnership. Adults aged between 18 and 44 (inclusive) without known diabetes and with at least one risk factor for diabetes will undergo a saliva DNA and capillary blood test and complete a questionnaire. Depending on their risk levels, participants will be stratified to high risk and low risk progressors to diabetes. The high risk progressors will undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT). All participants will receive a personalized report indicating their genetic and modifiable risk explained by nurses or doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices, weighing scale) to motivate behavioural change. The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.
Read the detailed description
BACKGROUND AND RATIONALE:
In Hong Kong, 1 in 10 adults have diabetes. In hospital-based clinic setting, 1 in 5 adults with diabetes were diagnosed before the age of 40, i.e. young-onset diabetes (YOD). The latter is the major driver of recurrent hospitalizations, critical illnesses and premature death. Compared to fasting plasma glucose (FPG) or HbA1c, 2-hour PG is needed to detect impaired glucose tolerance (IGT) and diabetes (DM). Besides, 2-h PG is more robust than FPG or HbA1c in predicting major events and death. The selection of participants with IGT for intervention is based on the positive effects of lifestyle modification and metformin only in individuals with IGT and not in individuals with isolated IFG in randomized clinical trials. Besides, there is strong familial tendency of YOD and based on our published and in-house 20-year prospective data in a workforce, 80% of people who developed DM came from 20-30% of individuals with high genetic risk unmasked by modifiable risk factors such as obesity and smoking.
In this implementation project, investigators shall use a 2-stepped approach to identify adults aged between 18 and 44 (inclusive) with genetic predisposition to undergo yearly OGTT to diagnose IGT and diabetes early for intervention. Investigators shall apply the proprietary DForesee (DF) risk algorithm including clinical and biogenetic risk factors to select the top 25% of participants at the highest risk for IGT or diabetes in next 10 years to undergo yearly OGTT accompanied by a risk-based intervention program.
STUDY DESIGN AND METHODS:
By using quasi-experimental design based on an evidence-based multi-component strategy, investigators aim to detect and delay the onset of diabetes in adults aged less than 45 years. Investigators aim to identify 9,000 adults aged between 18 and 44 years (inclusive) in community- and clinic settings during a 2-year period, followed by 2 years of risk-stratified intervention. Investigators shall use clinical and biogenetic assessment including DNA testing, capillary blood test and administration of questionnaires to classify participants to high risk and low risk progressors. All participants will receive risk-based intervention. Low risk progressors will receive a personalized report indicating their genetic and modifiable risk explained by nurses and with repeated clinical and biogenetic assessment at year 2. The high risk progressors will additionally undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT) and will receive a personalized report explained by doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices for IGT and DM groups only, weighing scale for all high risk progressors) to motivate behavioural change.
INCLUSION and EXCLUSION CRITERIA Age 18-44 (inclusive) years without known diabetes, at least one risk factor for diabetes and with usual place of residence in Hong Kong, The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension, high blood glucose level, abnormal lipid level/ vascular disease, or fatty liver, history of gestational diabetes polycystic ovary syndrome or delivery of baby≥ 4kg (for women only), less than 150mins of physical activity every week.
People with known diabetes or conditions considered to be unsuitable by the project team including illiteracy will be excluded.
OUTCOME MEASURES The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.
- Conditions
- Diabetes, Pre Diabetes, Hypertension, Dyslipidemia, Obesity
- Being tested
- Risk assessment with biogenetic and clinical test to predict diabetes risk, Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors, Medication, Continuous glucose monitoring (CGM) devices and/or weighing scale, Visit to family doctor with nurse education
- Keywords
- Diabetes, Pre Diabetes, YOD, DM, Young Onset diabetes, Genetic test, Management, Prevention, Hypertension, Dyslipidemia, Obesity
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Hypertension, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk assessment with biogenetic and clinical test to predict diabetes riskGenetic
All participants will undergo genetic test and clinical measurement including body weight, body height, blood pressure, waist circumference and capillary blood glucose to predict diabetes risk with report explanation by doctors (for high risk, IGT and DM) and nurses (low risk). Genetic report will be updated annually for high risk and IGT group using updated clinical factors (e.g. age, BMI, BP).
Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factorsDiagnostic test
High risk progressors will undergo OGTT and measurement of CKM factors at baseline. In those without IGT or diabetes, they will undergo OGTT and CKM risk factor assessment annually for 2 years. The IGT group will additionally have measurement of beta-cell function (HOMA indexes) and the DM group will additionally have autoimmune marker measurement.
MedicationDrug
Nurse and medical consultations and subsidized medications (metformin, statin, ARB) will be provided to the high risk progressor, IGT and diabetes groups as appropriate for control of glucose and CKM risk factors.
Continuous glucose monitoring (CGM) devices and/or weighing scaleDevice
All high risk progressors will be given subsidized weighing scale and low-intensity laboratory assessments, nurse and doctor consultation, regular WhatsApp messages and webinars for 2 years. The IGT and DM group will receive additional subsidized CGM devices for empowerment.
Visit to family doctor with nurse educationBehavioural
All participants in high risk, IGT and diabetes groups will have regular follow-up by family doctors and nurses.
Joint Asia Diabetes Evaluation (JADE) assessmentDiagnostic test
Participants found to have diabetes on OGTT will undergo annual JADE assessment which include eye/foot/urine/blood tests with issue of a personalized JADE report. The JADE Program is a quality improvement program to improve self management and inform shared decision making between doctor and patient.
Education webinars, workshops and health messagesBehavioural
All participants would join the webinars. High risk progressors, IGT and DM group will receive regular WhatsApp messages, webinars and workshops.
| Study group | Role | What they receive |
|---|---|---|
| Low risk | Other | Low risk progressors are those who are in the bottom 75% of the risk score based on both clinical and biogenetic risk markers Receives: Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk; Behavioral: Education webinars, workshops and health messages |
| High risk progressors | Other | High risk progressors are those who are in the top 25% of the risk score based on both clinical and biogenetic risk markers. They will undergo yearly OGTT to detect undiagnosed diabetes or impaired glucose tolerance (IGT) for early intervention. They will also receive low intensity team-based care with regular empowerment using webinars and whatsapp messages for 2 years. Receives: Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk; Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors; Drug: Medication; Device: Continuous glucose monitoring (CGM) devices and/or weighing scale; Behavioral: Visit to family doctor with nurse education; Behavioral: Education webinars, workshops and health messages |
| Impaired glucose tolerance (IGT) | Other | Subjects with IGT will receive team-based care including lifestyle modification and early use of metformin, subsidized weighing scale and CGM, supplemented by WhatsApp messages and webinars for empowerment for 2 years Receives: Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk; Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors; Drug: Medication; Device: Continuous glucose monitoring (CGM) devices and/or weighing scale; Behavioral: Visit to family doctor with nurse education; Behavioral: Education webinars, workshops and health messages |
| Diabetes | Other | Subjects with newly diagnosed diabetes will receive team-based care with structured assessment, JADE personalized report, testing for autoimmune markers, , subsidized CGM, weighing scale and medications with regular WhatsApp messages and webinars for empowerment for 2 years Receives: Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk; Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors; Drug: Medication; Device: Continuous glucose monitoring (CGM) devices and/or weighing scale; Behavioral: Visit to family doctor with nurse education; Diagnostic Test: Joint Asia Diabetes Evaluation (JADE) assessment; Behavioral: Education webinars, workshops and health messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of prediabetes or diabetes in the high and low risk progressor groups
DForesee risk score will be used to define the high and low risk progressor groups at baseline and oral glucose tolerance test (OGTT) will be used to detect IGT or diabetes in the high risk progressor group and 10% of low risk progressor group.
DForesee risk score consists of the overall risk for prediabetes and the overall risk for type 2 diabetes which will have 4 different risk levels including low, moderate, high and very high risk.
Measured: From the date of recruitment until the end of the programme in 2 years.
Secondary outcomes (13)
The conversion rate of glycaemic status including Impaired fasting glucose (IFG), Impaired glucose tolerance (IGT) and diabetes over the study period
The conversion rate of impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and diabetes will be assessed for all high risk progressors using OGTT at baseline and annually. In addition,1 in 10 of the low risk progressors will also undergo OGTT at baseline and year 2 to ascertain their conversion rate to IGT or diabetes.
Measured: From the date of recruitment until the end of the programme in 2 years.
Change in the HbA1c over the study period
High risk progressors will undergo yearly assessment to evaluate the HbA1c to determine the change in the blood glucose level during the program periods.
Measured: From the date of recruitment until the end of the Programme in 2 years
Change in the blood glucose level including FPG and 2-hour PG over the study period
High risk progressors will undergo yearly assessment to evaluate the blood glucose level including FPG and 2-hour PG to determine the change in the blood glucose level during the program periods. In addition, 1 in 10 of the low risk progressors will evaluate the blood glucose level including FPG and 2-hour PG at baseline and year 2.
Measured: From the date of recruitment until the end of the Programme in 2 years
Change in the blood pressure level over the study period
High risk progressors will measure the blood pressure including the systolic and diastolic blood pressure at least once a year to evaluate the change or control of blood pressure. In addition, low risk progressors will also measure the blood pressure at baseline and year 2.
Measured: From the date of the recruitment until the end of the Programme in 2 years
Change in lipids level including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides over study period
High risk progressors will undergo yearly assessment to evaluate the control and changes of lipids throughout the study period.
Measured: From the date of recruitment until the end of the programme in 2 years
Change in body weight over the study period
High risk progressors will undergo yearly assessment to evaluate the change in body weight over the study period. Low risk progressors will also measure the body weight at baseline and year 2.
Measured: From the date of the recruitment until the end of the programme in 2 years
Change in waist circumference over the study period
High risk progressors will undergo yearly assessment to evaluate the change or control of waist circumference. Low risk progressors will also measure the waist circumference at baseline and year 2.
Measured: From the date of the recruitment until the end of the Programme in 2 years
Change in albuminuria over the study period
High risk progressors will undergo yearly assessment to evaluate the change in albuminuria over the study period.
Measured: From the date of the recruitment until the end of the programme in 2 years
Change in health literacy over the study period by using questionnaire
Questionnaire will be used by all participants to assess the health literacy by comparing the number of questions being answered correctly at baseline and at year 2 of the programme. The questionnaire consists of 10 multiple choice questions with 5 options including the questions about the health knowledge on 4 highs (diabetes, hypertension, dyslipidemia and obesity) and healthy diet. There will be one point for each question with a total of 10 points. The higher scores mean a better outcome.
Measured: From the date of recruitment until the end of the programme in 2 years
Quality of life using EuroQoL with 5 demensions and 3 levels (EQ-5D-3L) Questionnaire
Questionnaire will be used to assess the quality of life (EuroQoL - EQ-5D-3L) of all participants at baseline and year 2. The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, and extreme problems (labelled 1-3).
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale numbered from 0 to 100. The endpoints are labelled 'The best health you can image' at number 100 and 'The worst health you can image' at number 0. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: From the date of recruitment until the end of the programme in 2 years
Change in lifestyles including eating habits, exercises, sleeping habits, smoking and alcohol over the study period by using questionnaire
Questionnaire, adopted from the questionnaire of a health promotion campaign named "Better Health for a Better Hong Kong", will be used to assess the change in lifestyles of all participants including eating habits, exercises, sleeping habits, smoking and alcohol at baseline and year 2.
The questionnaire consists of 38 questions with multiple choice and free text questions which will enquiry about the intake frequency and serving of different food types, frequency, duration and intensity of exercises, smoking and drinking frequency, sleeping duration, etc.
Measured: From the date of recruitment until the end of the programme in 2 years
The number of usage in healthcare resources such as clinic visits and hospital admissions
The number of usage in healthcare resources such as clinic visits and hospital admissions by self reporting by the participants during nurse and doctor consultations of high risk progressors and information from publicly available resources for all participants.
Measured: From the date of recruitment until the end of the programme in 2 years
Cost-effectiveness analysis by mearsuring the transition rate of progression from normal glucose tolerace to IGT and IGT to diabetes during 4 year programme
A Markov model will be developed to evaluate the cost-effectiveness of the study by measuring the transition rate of progression from normal glucose tolerance to IGT and IGT to diabetes during the programme period. Cost effectiveness results will be estimated using incremental cost effectiveness ratios (ICER) derived by dividng the difference in total costs by difference in health outcome or effect (QALYs or YLL).
Measured: From the date of recruitment until the end of the programme in 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start23 Nov 2024
- Primary completionOct 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juliana CN Chan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, St. James' Settlement, Asia Diabetes Foundation
- Responsible party
- Sponsor-investigator, Juliana CN Chan, Asia Diabetes Foundation
- Investigators
- Juliana CN Chan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693934
- Sponsor's protocol ID
- CRE-2024.243
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent for sharing of individual data have not been sought from participants. Summary statistics may be shared depending on nature of request
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jockey Club Precision Prevention Programme on Young Onset Diabetes
- ClinicalTrials.gov ID
- NCT06693934
- Acronym / sponsor ID
- CRE-2024.243
- Conditions
- Diabetes, Pre Diabetes, Hypertension, Dyslipidemia, Obesity
- Keywords
- Diabetes, Pre Diabetes, YOD, DM, Young Onset diabetes, Genetic test, Management, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Juliana CN ChanUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, St. James' Settlement, Asia Diabetes Foundation
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 Nov 2024 (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 is a community-based implementation program consisting of multiple components delivered by a multidisciplinary team to detect and prevent young onset diabetes with precision and value using biogenetic markers, digital tools, integrated care through public private partnership. Adults aged between 18 and 44 (inclusive) without known diabetes and with at least one risk factor for diabetes will undergo a saliva DNA and capillary blood test and complete a questionnaire. Depending on their risk levels, participants will be stratified to high risk and low risk progressors to diabetes. The high risk progressors will undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT). All participants will receive a personalized report indicating their genetic and modifiable risk explained by nurses or doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices, weighing scale) to motivate behavioural change. The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.
Detailed description
BACKGROUND AND RATIONALE:
In Hong Kong, 1 in 10 adults have diabetes. In hospital-based clinic setting, 1 in 5 adults with diabetes were diagnosed before the age of 40, i.e. young-onset diabetes (YOD). The latter is the major driver of recurrent hospitalizations, critical illnesses and premature death. Compared to fasting plasma glucose (FPG) or HbA1c, 2-hour PG is needed to detect impaired glucose tolerance (IGT) and diabetes (DM). Besides, 2-h PG is more robust than FPG or HbA1c in predicting major events and death. The selection of participants with IGT for intervention is based on the positive effects of lifestyle modification and metformin only in individuals with IGT and not in individuals with isolated IFG in randomized clinical trials. Besides, there is strong familial tendency of YOD and based on our published and in-house 20-year prospective data in a workforce, 80% of people who developed DM came from 20-30% of individuals with high genetic risk unmasked by modifiable risk factors such as obesity and smoking.
In this implementation project, investigators shall use a 2-stepped approach to identify adults aged between 18 and 44 (inclusive) with genetic predisposition to undergo yearly OGTT to diagnose IGT and diabetes early for intervention. Investigators shall apply the proprietary DForesee (DF) risk algorithm including clinical and biogenetic risk factors to select the top 25% of participants at the highest risk for IGT or diabetes in next 10 years to undergo yearly OGTT accompanied by a risk-based intervention program.
STUDY DESIGN AND METHODS:
By using quasi-experimental design based on an evidence-based multi-component strategy, investigators aim to detect and delay the onset of diabetes in adults aged less than 45 years. Investigators aim to identify 9,000 adults aged between 18 and 44 years (inclusive) in community- and clinic settings during a 2-year period, followed by 2 years of risk-stratified intervention. Investigators shall use clinical and biogenetic assessment including DNA testing, capillary blood test and administration of questionnaires to classify participants to high risk and low risk progressors. All participants will receive risk-based intervention. Low risk progressors will receive a personalized report indicating their genetic and modifiable risk explained by nurses and with repeated clinical and biogenetic assessment at year 2. The high risk progressors will additionally undergo annual oral glucose tolerance test to detect diabetes and impaired glucose tolerance (IGT) and will receive a personalized report explained by doctors. All participants will be offered regular access to webinars for education and empowerment for 2 years. The high risk group will additionally receive a 2-year risk-stratified intervention with different combinations of care interventions. These include clinical and laboratory assessment for comprehensive evaluation of cardiovascular-kidney-metabolic risks, medical and nurse consultations, empowerment by health messages, webinars, face-to-face workshops, subsidies for medications and self-monitoring tools (e.g. CGM devices for IGT and DM groups only, weighing scale for all high risk progressors) to motivate behavioural change.
INCLUSION and EXCLUSION CRITERIA Age 18-44 (inclusive) years without known diabetes, at least one risk factor for diabetes and with usual place of residence in Hong Kong, The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension, high blood glucose level, abnormal lipid level/ vascular disease, or fatty liver, history of gestational diabetes polycystic ovary syndrome or delivery of baby≥ 4kg (for women only), less than 150mins of physical activity every week.
People with known diabetes or conditions considered to be unsuitable by the project team including illiteracy will be excluded.
OUTCOME MEASURES The outcomes will be analysed within the REAIM framework (reach, effectiveness, adoption, implementation and maintenance), progresssion to prediabetes or diabetes, patient reported outcomes and cost effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk | Other | Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk, Behavioral: Education webinars, workshops and health messagesLow risk progressors are those who are in the bottom 75% of the risk score based on both clinical and biogenetic risk markers |
| High risk progressors | Other | Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk, Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors, Drug: Medication, Device: Continuous glucose monitoring (CGM) devices and/or weighing scale, Behavioral: Visit to family doctor with nurse education, Behavioral: Education webinars, workshops and health messagesHigh risk progressors are those who are in the top 25% of the risk score based on both clinical and biogenetic risk markers. They will undergo yearly OGTT to detect undiagnosed diabetes or impaired glucose tolerance (IGT) for early intervention. They will also receive low intensity team-based care with regular empowerment using webinars and whatsapp messages for 2 years. |
| Impaired glucose tolerance (IGT) | Other | Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk, Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors, Drug: Medication, Device: Continuous glucose monitoring (CGM) devices and/or weighing scale, Behavioral: Visit to family doctor with nurse education, Behavioral: Education webinars, workshops and health messagesSubjects with IGT will receive team-based care including lifestyle modification and early use of metformin, subsidized weighing scale and CGM, supplemented by WhatsApp messages and webinars for empowerment for 2 years |
| Diabetes | Other | Genetic: Risk assessment with biogenetic and clinical test to predict diabetes risk, Diagnostic Test: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors, Drug: Medication, Device: Continuous glucose monitoring (CGM) devices and/or weighing scale, Behavioral: Visit to family doctor with nurse education, Diagnostic Test: Joint Asia Diabetes Evaluation (JADE) assessment, Behavioral: Education webinars, workshops and health messagesSubjects with newly diagnosed diabetes will receive team-based care with structured assessment, JADE personalized report, testing for autoimmune markers, , subsidized CGM, weighing scale and medications with regular WhatsApp messages and webinars for empowerment for 2 years |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 44 years old
- With at least one risk factor for diabetes
Key exclusion criteria (3 listed)
- Known history of Diabetes
- With conditions considered not suitable by the project team (including illiteracy)
- The risk factors for diabetes include central or general obesity, family history of diabetes, smoking history, history of hypertension/ high blood glucose level/ abnormal lipid level/ vascular disease/ fatty liver, history of gestational diabetes/ polycystic ovary syndrome/ delivery of baby≥ 4kg (for women only), and less than 150mins of physical activity every week.
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 |
|---|---|---|
| Risk assessment with biogenetic and clinical test to predict diabetes riskAll participants will undergo genetic test and clinical measurement including body weight, body height, blood pressure, waist circumference and capillary blood glucose to predict diabetes risk with report explanation by doctors (for high risk, IGT and DM) and nurses (low risk). Genetic report will be updated annually for high risk and IGT group using updated clinical factors (e.g. age, BMI, BP). | Genetic | Diabetes, High risk progressors, Impaired glucose tolerance (IGT), Low risk |
| Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factorsHigh risk progressors will undergo OGTT and measurement of CKM factors at baseline. In those without IGT or diabetes, they will undergo OGTT and CKM risk factor assessment annually for 2 years. The IGT group will additionally have measurement of beta-cell function (HOMA indexes) and the DM group will additionally have autoimmune marker measurement. | Diagnostic test | Diabetes, High risk progressors, Impaired glucose tolerance (IGT) |
| MedicationNurse and medical consultations and subsidized medications (metformin, statin, ARB) will be provided to the high risk progressor, IGT and diabetes groups as appropriate for control of glucose and CKM risk factors. | Drug | Diabetes, High risk progressors, Impaired glucose tolerance (IGT) |
| Continuous glucose monitoring (CGM) devices and/or weighing scaleAll high risk progressors will be given subsidized weighing scale and low-intensity laboratory assessments, nurse and doctor consultation, regular WhatsApp messages and webinars for 2 years. The IGT and DM group will receive additional subsidized CGM devices for empowerment. | Device | Diabetes, High risk progressors, Impaired glucose tolerance (IGT) |
| Visit to family doctor with nurse educationAll participants in high risk, IGT and diabetes groups will have regular follow-up by family doctors and nurses. | Behavioural | Diabetes, High risk progressors, Impaired glucose tolerance (IGT) |
| Joint Asia Diabetes Evaluation (JADE) assessmentParticipants found to have diabetes on OGTT will undergo annual JADE assessment which include eye/foot/urine/blood tests with issue of a personalized JADE report. The JADE Program is a quality improvement program to improve self management and inform shared decision making between doctor and patient. | Diagnostic test | Diabetes |
| Education webinars, workshops and health messagesAll participants would join the webinars. High risk progressors, IGT and DM group will receive regular WhatsApp messages, webinars and workshops. | Behavioural | Diabetes, High risk progressors, Impaired glucose tolerance (IGT), Low risk |
Primary outcome
Incidence of prediabetes or diabetes in the high and low risk progressor groups
Time frame: From the date of recruitment until the end of the programme in 2 years.
DForesee risk score will be used to define the high and low risk progressor groups at baseline and oral glucose tolerance test (OGTT) will be used to detect IGT or diabetes in the high risk progressor group and 10% of low risk progressor group. DForesee risk score consists of the overall risk for prediabetes and the overall risk for type 2 diabetes which will have 4 different risk levels including low, moderate, high and very high risk.
13 secondary outcomes
The conversion rate of glycaemic status including Impaired fasting glucose (IFG), Impaired glucose tolerance (IGT) and diabetes over the study period
Time frame: From the date of recruitment until the end of the programme in 2 years.
Change in the HbA1c over the study period
Time frame: From the date of recruitment until the end of the Programme in 2 years
Change in the blood glucose level including FPG and 2-hour PG over the study period
Time frame: From the date of recruitment until the end of the Programme in 2 years
Change in the blood pressure level over the study period
Time frame: From the date of the recruitment until the end of the Programme in 2 years
Change in lipids level including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides over study period
Time frame: From the date of recruitment until the end of the programme in 2 years
Change in body weight over the study period
Time frame: From the date of the recruitment until the end of the programme in 2 years
Change in waist circumference over the study period
Time frame: From the date of the recruitment until the end of the Programme in 2 years
Change in albuminuria over the study period
Time frame: From the date of the recruitment until the end of the programme in 2 years
Change in health literacy over the study period by using questionnaire
Time frame: From the date of recruitment until the end of the programme in 2 years
Quality of life using EuroQoL with 5 demensions and 3 levels (EQ-5D-3L) Questionnaire
Time frame: From the date of recruitment until the end of the programme in 2 years
Change in lifestyles including eating habits, exercises, sleeping habits, smoking and alcohol over the study period by using questionnaire
Time frame: From the date of recruitment until the end of the programme in 2 years
The number of usage in healthcare resources such as clinic visits and hospital admissions
Time frame: From the date of recruitment until the end of the programme in 2 years
Cost-effectiveness analysis by mearsuring the transition rate of progression from normal glucose tolerace to IGT and IGT to diabetes during 4 year programme
Time frame: From the date of recruitment until the end of the programme in 2 years
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 19 Mar 2025.
- Individual participant dataSharing planned: No. Consent for sharing of individual data have not been sought from participants. Summary statistics may be shared depending on nature of request
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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.
Juliana CN Chan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk assessment with biogenetic and clinical test to predict diabetes risk, Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors and Medication in people with Diabetes and Pre Diabetes, run by Juliana CN Chan at 1 site in Hong Kong.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 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 Hong Kong. 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 Juliana CN Chan (+85226376624, jchan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of prediabetes or diabetes in the high and low risk progressor groups (time frame: From the date of recruitment until the end of the programme in 2 years.). 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 19 Mar 2025.