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

August 6, 2015 updated by: Asia Diabetes Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control as measured by HbA1c compared to baseline
Time Frame: 36 months
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of BP compared to baseline.
Time Frame: 36 months
Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year.
36 months
Control of low density lipoprotein (LDL) cholesterol compared to baseline.
Time Frame: 36 months
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
36 months
Control of BMI and other obesity indices compared to baseline
Time Frame: 36 months
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asia Diabetes Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2012.136-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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