Clinical trial

Jockey Club Precision Prevention Programme on Young Onset Diabetes

Recruiting now · Not applicable · 1 countries · Registry ID NCT06693934

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 44 Years

SexAll

Healthy volunteersAccepted

ConditionDiabetes, Pre Diabetes, Hypertension, Dyslipidemia, Obesity

Full registry criteria

Inclusion Criteria: * Aged between 18 and 44 years old * With at least one risk factor for diabetes Exclusion Criteria: * 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.

Treatments and study arms

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).

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.

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.

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.

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.

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.

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.

Primary outcomes

Incidence of prediabetes or diabetes in the high and low risk progressor groupsFrom 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.

Study locations

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Asia Diabetes Foundation🇭🇰 Hong Kong, Hong Kong

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Amy Fu, MPHContact