Suspended

EMERALDEvaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team

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What is being tested

EMERALD

+ Usual Care

Other
Who is being recruted

Body Weight+9

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 70 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorAsia Diabetes Foundation
Study ContactJuliana Chan, MDMore contacts
Last updated: August 10, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

Diabetic patients are at high risk for co-morbidities which are closely related to disease duration and coexisting cardiovascular risk factors and complications. Data has shown that the following 3 groups of diabetic patients are at extremely high risk for future events: Obese type 2 diabetic patients: Weight control is a major therapeutic challenge which often requires cognitive-psychological-behavioral therapy (CBT) in addition to pharmacological and surgical interventions. After long disease duration, often characterized by the presence of complications, many obese diabetic patients need insulin to control glycemia which put them at risk of further weight gain which sets up a vicious cycle. Young type 2 diabetic patients: In both Pima Indian and Caucasian type 2 diabetic patients, young age of onset substantially increased risk of cardiovascular and renal complications, mainly due to long disease duration. Furthermore, these patients often default follow up or are non-compliant due to competing priorities and lack of symptoms. These young patients also have marked phenotypic heterogeneity characterised by insulin insufficiency and/or obesity with strong family history. Diabetic patients with established cardiovascular-renal complications. In a series of analyses, Chinese type 2 diabetic patients with established cardiovascular and kidney disease had 38% event rates including all-cause death and cardiovascular-renal complications including peripheral vascular disease (PVD) over 5 years. These 3 groups of patients are difficult to treat with many unmet needs requiring complex treatment regimens, intensive counselling and emotional support. In a series of studies, the investigators have confirmed the marked benefits of using a team approach to deliver structured care with particular emphasis on continuation of care and periodic reminders on clinical outcomes. Preliminary analysis from our peer support program also demonstrated the benefits of utilizing organized and visual information to communicate personalized risks and targets, further augmented by peer support, to improve risk factor control in type 2 diabetic patients.

Principal SponsorAsia Diabetes Foundation
Study ContactJuliana Chan, MDMore contacts
Last updated: August 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightDiabetes MellitusObesity

Criteria

3 inclusion criteria required to participate
Diabetic patients with established cardiovascular-renal complications: HbA1c > 8% and known cardiovascular and renal complications with chronic kidney disease (CKD) stage 3-4 (i.e. estimated glomerular filtration rate < 60 to > 15 ml/min/ per 1.73m2) aged 18-70 years

Obese type 2 diabetic patients: body mass index (BMI) > 27 kg/m2 and/or waist circumference (WC) > 80cm in women and > 90cm in men and HbA1c > 8% aged 18-70 years

Young type 2 diabetic patients: age 35-55 years and HbA1c > 8%

4 exclusion criteria prevent from participating
Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)

Any medical illness or condition as judged by the investigators as ineligible to participate the study

Life expectancy less than 12 months

Type 1 diabetes

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients assigned to the EMERALD group will be invited to join the multi-component program which will last for 1 year. This program will be held on a 4-weekly basis for the first 3-4 months followed by a maintenance program involving 2-4 group activities every year. Between clinic visits, patients in this group will also receive telephone reminders from the staff and peer supporters to reinforce compliance and for social support.

Group II

Active Comparator
Irrespective of the assignment group, all patients will undergo a baseline comprehensive assessment using the JADE portal disease management system. All patients will also receive a 2-hour session on how to interpret their individualised JADE report and risk profiles, whilst the importance of achieving targets and optimizing self care will be reinforced. Patients assigned to the UC group will be followed up in their usual clinic according to the 'standard' practice.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

DMEC Centre, Prince of Wales Hospital

Shatin, Hong KongOpen DMEC Centre, Prince of Wales Hospital in Google Maps
SuspendedOne Study Center