Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by a Diabetes Specialist Team (EMERALD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Asia Diabetes Foundation
Sponsor:
Information provided by (Responsible Party):
Asia Diabetes Foundation
ClinicalTrials.gov Identifier:
NCT01690208
First received: September 19, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

This is a pilot translational study aiming to compare the effects of a multi-component care program with personalized drug regimen augmented by behavioural therapy with psychological support and peer influence, led by a diabetes specialist team on metabolic control, psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus usual care.

The study hypothesis is to evaluate a novel individualized, multicomponent care program to optimize glycemic control in difficult-to-treat type 2 diabetic patients.


Condition Intervention
Diabetes
Obesity
Other: EMERALD
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team

Resource links provided by NLM:


Further study details as provided by Asia Diabetes Foundation:

Primary Outcome Measures:
  • Glycemic control as measured by HbA1c compared to baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.


Secondary Outcome Measures:
  • Control of BP compared to baseline. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year.

  • Control of low density lipoprotein (LDL) cholesterol compared to baseline. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.

  • Control of BMI and other obesity indices compared to baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.


Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMERALD
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.
Other: EMERALD

Patients assigned to the EMERALD group will be followed up at a Diabetes Centre led by the nurses and supported by diabetologists, with a particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm.

These patients will also undergo an intensive 3 to 4 months empowerment program where patients within the same group, and therefore sharing similar profiles, will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. Between medical visits, the nurses or HCA will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule.

Active Comparator: Usual Care

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.

Other: Usual Care
Patients randomised to the usual care group will receive their routine care after the initial baseline comprehensive assessment & explanation of the JADE reports. A repeat comprehensive assessment will then be conducted at year 3.

Detailed Description:

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:

  1. 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.
  2. 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.
  3. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%
  • 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.

Exclusion Criteria:

  • Type 1 diabetes
  • Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)
  • Life expectancy less than 12 months
  • Any medical illness or condition as judged by the investigators as ineligible to participate the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690208

Contacts
Contact: Juliana Chan, MD jchan@cuhk.edu.hk
Contact: Rebecca Wong wongymr@ha.org.hk

Locations
Hong Kong
DMEC Centre, Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Rebecca Wong       wongymr@ha.org.hk   
Contact: Tammy So       tammytyso@yahoo.com.hk   
Sponsors and Collaborators
Asia Diabetes Foundation
Investigators
Principal Investigator: Juliana Chan, MD Asia Diabetes Foundation
  More Information

No publications provided

Responsible Party: Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT01690208     History of Changes
Other Study ID Numbers: CRE-2012.136-T
Study First Received: September 19, 2012
Last Updated: September 20, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Asia Diabetes Foundation:
Diabetes
Structure Care

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014