Hong Kong Diabesity Register & 3-Year Trial on Integrated Care for Chinese With Diabesity
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About
People with diabetes and obesity (diabesity) are difficult to treat with many unmet needs requiring personalized treatment regimens, intensive counselling and emotional support. Here, we propose to conduct a pragmatic trial including 2 parts: (1) establishment of a register for Hong Kong Chinese with diabesity and through this register, identify participants consecutively to enter (2) a 3-year randomized clinical trial to assess the effects of multicomponent integrated care program supported by a team of endocrinologist, dietitian, psychologist and research assistant with elements including medical therapy, cognitive behavioural therapy, e-care, artificial intelligence chatbot, biofeedback, peer support to improve the physical and mental health in people with diabesity, with weight reduction as primary outcome. Other outcomes include cardiometabolic risk factors, diabetes distress, lifestyles and sleep hygiene.
Full description
Diabetes is both a public and personal health disaster if not diagnosed, treated or managed properly. Over 60% of all cause deaths and disabilities including stroke, leg amputation, heart disease, cancer, kidney disease, depression to name but a few are causally linked to diabetes. In the United Kingdom Prospective Diabetes Study (UKPDS), a landmark clinical trial of patients with type 2 diabetes, 0.9% reduction in glycated hemoglobin (HbA1c) reduced diabetes-related microvascular complications by 12-25%. In the 10-year post-trial follow-up period, the benefits of attaining glycemic control early had a legacy effect in reducing all clinical outcomes including cardiovascular complications and death. Nonetheless, it is a worldwide phenomenon that majority of people with type 2 diabetes are not reaching glycemic goals due to clinical inertia with delayed escalation of therapy, poor treatment compliance and/or insufficient self management.
Since 1995, as part of a quality improvement program, patients attending our twice-weekly diabetic complication screening sessions at the Prince of Wales Hospital (PWH) underwent detailed documentations of clinical and biochemical information which formed the basis of the Hong Kong Diabetes Register. Data from this prospective cohorts and others have shown that obese people with type 2 diabetes are particularly difficult to treat with extremely high risk for future events. Weight control is a major therapeutic challenge which often requires cognitive-psychological-behavioral therapy (CBT) in addition to pharmacological which at times might call for surgical interventions. Many traditionally used glucose lowering agents, such as sulphonylurea and insulin, can cause weight gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing levels of free fatty acids from adipose tissues. During a 6-month study, patients with type 2 diabetes treated with intensive insulin therapy dropped their HbA1c by 2.6% but gained an average of 8.7kg. Similarly, data from the UKPDS which recruited newly diagnosed type 2 diabetes, showed that patients had significant weight gain during a 10-year follow up period, particularly those on insulin therapy.
In a prospective analysis, insulin-treated type 2 diabetic patients with residual beta cell function as evidenced by high fasting serum C-peptide levels, had the highest rate of cardiovascular events of over 10%. This high event rate might be due to long disease duration, renal impairment and autonomic neuropathy with incresaed risk of hypoglycemia which substantially increased the risk of cardivoascular disease. People with diabesity have many unmet needs which require individualized therapy, intensive counselling and emotional support which cannot be adequately addressed in a busy clinic setting with 10-15 minute consultation. Besides, many patients with diabetes of working age tend to default due to competing priorities and silent nature of the disease and regrettably only to present with preventable complications after a few years.
In a series of randomized studies and disease management programs which has demonstrated the benefits of team approach, case management, quality improvement and patient empowerment on risk factor control, we have confirmed the marked benefits of using a interdisciplinary team to deliver protocol-driven care on clinical outcomes. Important features of this program included continuation of care through periodic reminders, decision support, empowerment, peer support and feedback. In a multicentre randomized study involving over 600 type 2 diabetic patients, we have demonstrated the benefits of a web-based disease management program,Joint Asia Diabetes Evaluation (JADE) program, which provides integrated and visual information to communicate personalized risks and treatment targets on reducing multiple risk factors, reducing treatment non-compliance, improving psychological health and enhancing self efficiacy in 20-30% of participants . Amongst those with negative emotions who accounted for 20% of the cohort, peer support further improved compliance and reduced hospitalization rates.
Against this background, we propose to conduct a study with 2 parts: 1) First, the establishment of Diabesity Register of Hong Kong Chinese, and through this Diabesity Register, identify eligible participants to enter: 2) a 3-year Randomized Clinical Trial (RCT) to evaluate the effectiveness of multicomponent integrated care (MIC) program in these people with diabesity.
Enrollment
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Inclusion criteria
- Type 2 diabetes;
- Obesity reaching action level as defined as body mass index (BMI) ³27.5 kg/m2 and/or waist circumference (WC) ³80cm in women and ³90cm in men;
- Age between 18 and 50 years;
- Able to conversate with smartphone technology and web-based program.
- Able to read Chinese and communicate using Chinese.
Exclusion criteria
- Type 1 diabetes;
- Active malignant disease including those with history of malignant disease less than 5 years of disease-free duration;
- Life expectancy less than 12 months;
- Any medical illness or condition as judged by the investigators as ineligible to participate the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Central trial contact
Alice Pik Shan Kong, MD
Data sourced from clinicaltrials.gov
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