DiabetesEMERALDNCT01690208
Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by a Diabetes Specialist Team
A study testing EMERALD in people with Diabetes and Obesity, run by Asia Diabetes Foundation at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- EMERALD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Juliana Chan, MD contact
Rebecca Wong contact
Hong Kong1 site, 1 recruiting
- Recruiting
DMEC Centre, Prince of Wales Hospital
Shatin
Rebecca Wong, wongymr@ha.org.hk
Tammy So, tammytyso@yahoo.com.hk
About this study
Official title: 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.
Read the 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:
- 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.
- Being tested
- EMERALD, Usual Care
- Keywords
- Diabetes, Structure Care
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMERALDOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EMERALD | 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. Receives: Other: EMERALD |
| Usual Care | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control as measured by HbA1c compared to baseline
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
Measured: 36 months
Secondary outcomes (3)
Control of BP compared to baseline.
Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year.
Measured: 36 months
Control of low density lipoprotein (LDL) cholesterol compared to baseline.
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
Measured: 36 months
Control of BMI and other obesity indices compared to baseline
Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia Diabetes Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana Chan, MD, Principal investigator, Asia Diabetes Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690208
- Sponsor's protocol ID
- CRE-2012.136-T
- Acronym
- EMERALD
- Status last verified
- Aug 2015
- First submitted
- 19 Sep 2012
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team
- ClinicalTrials.gov ID
- NCT01690208
- Acronym / sponsor ID
- EMERALD / CRE-2012.136-T
- Keywords
- Diabetes, Structure Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Asia Diabetes FoundationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMERALD | Experimental | Other: EMERALDPatients 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. |
| Usual Care | Active comparator | Other: Usual CareIrrespective 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMERALDPatients 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. | Other | EMERALD |
| Usual CarePatients 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. | Other | Usual Care |
Primary outcome
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.
3 secondary outcomes
Control of BP compared to baseline.
Time frame: 36 months
Control of low density lipoprotein (LDL) cholesterol compared to baseline.
Time frame: 36 months
Control of BMI and other obesity indices compared to baseline
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana Chan, MD contact
Rebecca Wong contact
Juliana Chan, MD principal investigator
Asia Diabetes Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMERALD in people with Diabetes and Obesity, run by Asia Diabetes Foundation at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Chan, MD (jchan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control as measured by HbA1c compared to baseline (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.