Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.
Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin. PART 1: Objective: To characterize Chinese patients diabetes classified by fasting CP and GADA positivity and their prognostic significance. Methods: Fasting CP levels and GADA in stored biosamples of 4000 patients in the Hong Kong Diabetes Register (HKDR) followed up since 1995. PART 2: Objective: To uncover genetic variants/sequences associated with familial YOD. Methods: Whole genome sequencing (WGS) in stored DNA of 100-120 sibpairs of YOD after 13 years of follow-up for imputation with exome data of case-control cohort of YOD and genome wide association studies (GWAS) data of 200 YOD families and 6000 T2D patients. PART 3: Objectives: To examine the impacts of precision medicine augmented by information technology and biogenetic markers (JADEPRISM) on attainment of cardiometabolic targets at 1 year and clinical outcomes at 3 year (n=440), compared with JADE-augmented care (n=440) in YOD. Deliverables A catalogue of biogenetic markers to guide precision medicine augmented by the JADE-Technology to optimize clinical outcomes in YOD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
884
* JADE report and JADE APP * Biogenetic explanation * First-year intensive management by endocrinologists * Follow up by their usual care doctors for continue treatment regimen maintenance. * Yearly DM nurses follow up for blood taking and questionnaires
* JADE report and JADE APP * Attend their usual care clinic for ongoing treatment * Yearly DM nurses follow up for blood taking and questionnaires
The Chinese University of Hong Kong
Shatin, Hong Kong
Prevalence of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) in Chinese adult patients with T2D (Part 1 of study)
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose. We shall measure CP and GADA in 4000-5000 patients.
Time frame: through study completion, an average of 4 years
The correlation of C-Peptide (CP) and Glutamic Acid Decarboxylase Antibody (GADA) on clinical outcomes (Part 1 of study)
Between 1995 to 2004, all patients in the HKDR had structured assessment with storage of blood samples (collected at registration) for future research purpose.
Time frame: through study completion, an average of 4 years
Incidence of young-onset type 2 diabetes and its genetic susceptibility (Part 2 of study)
Between 1998 to 2013, subjects from the HKFDS and the community-based LKS cohort had storage of blood samples at registration.
Time frame: through study completion, an average of 4 years
Incidence of any diabetes-related micro/macrovascular endpoints (Part 3 of study)
Incident including cardiovascular disease (coronary heart disease, congestive heart failure, stroke, peripheral artery disease), chronic kidney disease, all-cause death and/or incident/progression/remission of albuminuria, estimated glomerular filtration rate, retinopathy, visual acuity and sensory neuropathy
Time frame: through study completion, an average of 4 year
The levels of CP and GADA and the number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of genetic variants for disease prognositication and classification to guide precision medicine in YOD (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of novel targets and pathways for discovery of drug targets with companian diagnostics (Part 1 and 2 of study)
Time frame: through study completion, an average of 4 years
The number of patients attaining ≥3 cardiometabolic risk factors (Part 3 of study)
Defined as A1c\<6,2%, blood pressure\<120/80 mmHg, LDL-C\<1.8 mmol/L , triglyceride\<1.2 mmol/L, waist circumference\<80 cm in women \<85 cm in men which has been shown to reduce cardiovascular-renal endpoint in the JDOIT- 3 Study compared to conventional targets (A1c\<7%, BP\<130/80, LDL-C\<1.8 mmol/L, triglyceride \<1.7 mmol/L)
Time frame: through study completion, an average of 4 years
Incidence of severe hypoglycaemia (Part 3 of study)
Defined as hospitalization due to hypoglycaemia
Time frame: through study completion, an average of 4 year
Rate of changes in glycaemic control (Part 3 of study)
changes in HbA1c
Time frame: through study completion, an average of 4 year
On-treatment changes in blood pressure (Part 3 of study)
measure both systolic and diastolic blood pressure in mmHg
Time frame: through study completion, an average of 4 year
On-treatment changes in lipid profiles (Part 3 of study)
measure the changes in Total cholesterol, Triglyceride, High-density lipo-protein cholesterol, Low-density lipo-protein cholesterol
Time frame: through study completion, an average of 4 year
On-treatment changes in Body Mass Index (Part 3 of study)
Measure by BW in kg
Time frame: through study completion, an average of 4 year
On-treatment changes in CP (Part 3 of study)
Measure by changes in C-peptide
Time frame: through study completion, an average of 4 year
Rate of changes in use of medications (Part 3 of study)
Time frame: through study completion, an average of 4 year
Changes in patient's Quality of life (Part 3 of study)
Measure by questionnaire: EQ-5D For Quality of life (Total 5 questions with total score 1-15, highest score indicates the worst outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's reported outcomes : Depression (Part 3 of study)
Measure by questionnaire: PHQ-9 For Depression (Total 9 questions with total score 0-27, highest score indicates the worst outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's compliance (Part 3 of study)
Measure by questionnaire: CQ-4 For Compliance (Total 4 questions with total score 0-4, highest score indicates the worst outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes empowerment (Part 3 of study)
Measure by Diabetes Empowerment Scale (DES-20 for efficacy) (Total 20 questions with total score 0-80, highest score indicates better outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes self care activities (Part 3 of study)
Measure by questionnaire: Summary of diabetes self care activities (SDSCA-15 For self care) (Total 15 questions with total score 0-105, highest score indicates better outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's perceived personal control (Part 3 of study)
Measure by Perceived personal control (PPC) questionnaire (Total 9 questions with total score 0-18, highest score indicates better outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's genetic counseling satisfaction (Part 3 of study)
Measure by Genetic counseling satisfaction scale (GCSS) (Total 6 questions with total score 1-30, highest score indicates better outcome)
Time frame: through study completion, an average of 4 year
Changes in patient's diabetes related distress (Part 3 of study)
Measures by questionnaire: Diabetes Distress Scale (DDS; total score from 17-102), comprising 3 subscales namely emotional, physician, regimen / social support. A lower score indicates better outcome
Time frame: through study completion, an average of 4 year
Changes in patient's Depression Anxiety Stress (Part 3 of study)
Measure by Depression Anxiety Stress Scale (DASS-21) (Total 21 questions with total score 0-63, lowest score indicates better outcome)
Time frame: through study completion, an average of 4 year
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