Jockey Club Precision Prevention Programme on Young Onset Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9,000
- 试验地点
- 1
- 主要终点
- Incidence of prediabetes or diabetes in the high and low risk progressor groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 44 years old
- •With at least one risk factor for diabetes
排除标准
- •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.
研究组 & 干预措施
Low risk
Low risk progressors are those who are in the bottom 75% of the risk score based on both clinical and biogenetic risk markers
干预措施: Risk assessment with biogenetic and clinical test to predict diabetes risk (Genetic)
Low risk
Low risk progressors are those who are in the bottom 75% of the risk score based on both clinical and biogenetic risk markers
干预措施: Education webinars, workshops and health messages (Behavioral)
Impaired glucose tolerance (IGT)
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
干预措施: Medication (Drug)
High risk progressors
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.
干预措施: Risk assessment with biogenetic and clinical test to predict diabetes risk (Genetic)
High risk progressors
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.
干预措施: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors (Diagnostic Test)
High risk progressors
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.
干预措施: Medication (Drug)
High risk progressors
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.
干预措施: Continuous glucose monitoring (CGM) devices and/or weighing scale (Device)
High risk progressors
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.
干预措施: Visit to family doctor with nurse education (Behavioral)
High risk progressors
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.
干预措施: Education webinars, workshops and health messages (Behavioral)
Impaired glucose tolerance (IGT)
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
干预措施: Risk assessment with biogenetic and clinical test to predict diabetes risk (Genetic)
Impaired glucose tolerance (IGT)
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
干预措施: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors (Diagnostic Test)
Impaired glucose tolerance (IGT)
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
干预措施: Continuous glucose monitoring (CGM) devices and/or weighing scale (Device)
Impaired glucose tolerance (IGT)
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
干预措施: Visit to family doctor with nurse education (Behavioral)
Impaired glucose tolerance (IGT)
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
干预措施: Education webinars, workshops and health messages (Behavioral)
Diabetes
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
干预措施: Risk assessment with biogenetic and clinical test to predict diabetes risk (Genetic)
Diabetes
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
干预措施: Oral glucose tolerance test (OGTT) and cardiovascular-kidney-metabolic (CKM) risk factors (Diagnostic Test)
Diabetes
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
干预措施: Medication (Drug)
Diabetes
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
干预措施: Continuous glucose monitoring (CGM) devices and/or weighing scale (Device)
Diabetes
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
干预措施: Visit to family doctor with nurse education (Behavioral)
Diabetes
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
干预措施: Joint Asia Diabetes Evaluation (JADE) assessment (Diagnostic Test)
Diabetes
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
干预措施: Education webinars, workshops and health messages (Behavioral)
结局指标
主要结局
Incidence of prediabetes or diabetes in the high and low risk progressor groups
时间窗: 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.
次要结局
- 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)
- Change in body weight over the study period(From the date of the recruitment until the end of the programme in 2 years)
- Change in waist circumference over the study period(From the date of the recruitment until the end of the Programme in 2 years)
- Change in albuminuria over the study period(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(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(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(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(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(From the date of recruitment until the end of the programme in 2 years)
研究者
Juliana CN Chan
Professor
Asia Diabetes Foundation