Jockey Club Precision Prevention Programme on Young Onset Diabetes

NCT06693934 | Recruiting

• 1 other identifier: CRE-2024.243
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes; Pre Diabetes; Hypertension; Dyslipidemia; Obesity

Keywords

Diabetes; Pre Diabetes; YOD; DM; Young Onset diabetes; Genetic test; Management; Prevention; Hypertension; Dyslipidemia; Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the date of recruitment until the end of the programme in 2 years.

• Change in the HbA1c over the study period

  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

  From the date of recruitment until the end of the Programme in 2 years

• Change in the blood pressure level over the study period

  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

  From the date of recruitment until the end of the programme in 2 years

Study Arms (4)

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

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.

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

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

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

Interventions

Risk assessment with biogenetic and clinical test to predict diabetes risk GENETIC

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).

Diabetes; High risk progressors; Impaired glucose tolerance (IGT); Low risk

Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors DIAGNOSTIC_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.

Diabetes; High risk progressors; Impaired glucose tolerance (IGT)

Medication DRUG

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.

Diabetes; High risk progressors; Impaired glucose tolerance (IGT)

Continuous glucose monitoring (CGM) devices and/or weighing scale DEVICE

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.

Diabetes; High risk progressors; Impaired glucose tolerance (IGT)

Visit to family doctor with nurse education BEHAVIORAL

All participants in high risk, IGT and diabetes groups will have regular follow-up by family doctors and nurses.

Diabetes; High risk progressors; Impaired glucose tolerance (IGT)

Joint Asia Diabetes Evaluation (JADE) assessment DIAGNOSTIC_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.

Diabetes

Education webinars, workshops and health messages BEHAVIORAL

All participants would join the webinars. High risk progressors, IGT and DM group will receive regular WhatsApp messages, webinars and workshops.

Diabetes; High risk progressors; Impaired glucose tolerance (IGT); Low risk

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 44 years old
• With at least one risk factor for diabetes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juliana CN Chan: lead
• Chinese University of Hong Kong: collaborator
• St. James' Settlement: collaborator
• Asia Diabetes Foundation: collaborator

Study Sites (1)

Asia Diabetes Foundation

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Hypertension; Dyslipidemias; Obesity

Interventions

Risk Assessment; Glucose Tolerance Test; Dosage Forms; Continuous Glucose Monitoring; Physical Examination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Pharmaceutical Preparations; Technology, Pharmaceutical; Monitoring, Physiologic

Study Officials

• Juliana CN Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana CN Chan

CONTACT

+85226376624; jchan@cuhk.edu.hk

Amy Fu

CONTACT

+85226376624; afu@adf.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 19, 2024
• Study Start: November 23, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)