DiabetesAP-JDNCT01631084
Comparing the Effect of Structured Care Versus Usual Care in Type 2 Diabetes Patients Across the Asia Pacific Region
A study testing JADE and DIAMOND in people with Diabetes, run by Asia Diabetes Foundation at 1 site in Hong Kong.
Trial summary
In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short) supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- JADE and DIAMOND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,834 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2012to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients who are willing or can be persuaded to return for 'regular' follow-up at 3-4 monthly intervals
- Patients with newly diagnosed or established disease, treated with lifestyle modification or blood glucose lowering drugs including oral agents with or without insulin
- For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:
- Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or
- Random or 2-hour PG >11.1 mmol/L (after 75 gram oral glucose tolerance test) on 2 or more occasions, and/or
- HbA1c >6.5%
Who cannot join
- Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
- Patients with reduced life expectancy (e.g. less than 6 months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life-threatening conditions
- Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
- Patients actively enrolled in another intervention study
- Patients who are unwilling to return for regular follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomized Program to Compare the Effect of the Joint Asia Diabetes Evaluation (JADE, Structured Care) Versus the DIAbetes MONitoring Database (DIAMOND, Usual Care) Programs in Type 2 Diabetes in the Asia Pacific Region
In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short) supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care) group.
All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter. Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a protocol based on risk stratification with predefined follow up (FU) schedules together with shared information and decision support (i.e. structured collaborative care). The DIAMOND protocol involves only baseline and yearly CA without predefined FU schedules or feedback of information between CA visits (i.e. usual care).
The primary composite endpoint is all-diabetes related clinical endpoints. The secondary composite endpoint is attainment of treatment goals and/or control of risk factors. The tertiary changes are behavioral changes, psychological well being and quality of life.
Read the detailed description
Rationale: Change of practice environment and an interdisciplinary team is needed to implement evidence-based diabetes care which requires risk stratification, periodic assessments, education and treatment to targets.
Hypothesis: The use of a web-based disease management program (Joint Asia Diabetes Evaluation (JADE) Program) delivered by a doctor-nurse-HCA team reduces the incidence of all diabetes-associated clinical endpoint and improves control of risk factors compared to usual care (DIAbetes MONitoring Database (DIAMOND) group) in type 2 diabetes.
Objective: To compare structured care using the JADE portal versus usual care using the DIAMOND portal on incidence of all-diabetes related events, physical and psychological health.
Study design: A multicentre, randomized, integrated disease management program Setting and patients: 600 patients from each site will be randomized to the JADE group (n=300) or the DIAMOND group (n=300) and followed up for at least 24 months.
Intervention: All patients will undergo comprehensive assessment (CA) guided by the templates in the respective portal at baseline, month 12 and 24. The JADE group will be further managed by a doctor-nurse-HCA team guided by the JADE portal with risk stratification program and recommendation to different care protocols with predefined follow up (FU) schedules, information sharing and decision supports.
Outcome measures: Primary composite outcomes include all diabetes-related clinical events; secondary composite outcomes include control of risk factors and tertiary composite outcomes include behavioral changes, psychological health, quality of life and cost-effective analysis.
- Conditions
- Diabetes
- Being tested
- JADE, DIAMOND
- Keywords
- Diabetes, Structured care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JADEOther
Patients are booked for reviews led by the doctor-nurse-HCA team every 2-4 months, preferably in a setting different from the busy clinics in order to facilitate group education and promote peer support.
Between each follow-up visit, the nurse or HCA will contact the patient by phone or email to remind them of the appointments (e.g. medical FU visit or laboratory tests), adhere to medications and healthy lifestyles, perform self glucose monitoring and provide psychosocial support, as appropriate.
DIAMONDOther
Patients randomized to the DIAMOND group will receive usual care after the initial baseline comprehensive assessment (CA), with repeat CA at 12 and 24 months.
| Study group | Role | What they receive |
|---|---|---|
| JADE | Experimental | Patients randomized to the JADE group will be followed according to protocol-driven diabetes care based on their individual risk levels, using a web-based disease management program. In addition to their annual comprehensive assessments at baseline, year 1 and year 2, all subsequent follow-up visits will be documented and entered into the JADE portal, which will then issue reports to both patients and doctor to promote sharing of information and informed decisions. Receives: Other: JADE |
| DIAMOND | Active comparator | Patients will receive a comprehensive assessment at baseline, year 1 and year 2. In the interim between these time points patients will be managed according to 'usual care' procedures. Receives: Other: DIAMOND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all diabetes-related clinical endpoints
- cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions)
- chronic kidney disease (eGFR<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR<15 ml/min/1.73m2)
- visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery
- lower extremity amputation or foot ulcers requiring hospitalizations
- major infections - pulmonary and non-pulmonary requiring hospitalizations
- all-site cancers
- death
Measured: 12 months
Secondary outcomes (1)
Proportions of patients with improved control of risk factors
- 2 or more of the 'ABC' targets: i) HbA1c<7%, ii) BP<130/80 mmHg, iii) LDL-C <2.6 mmol/L.
- and/or
- 2 of the following changes in risk factor control: i) at least 0.5% reduction in HbA1c, ii) at least 5 mmHg reduction in systolic BP, iii) at least 0.5 mmol/L reduction in LDL-C, iv) at least 3% reduction in body weight.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 20,834 participants (actual)
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
- NCT01631084
- Sponsor's protocol ID
- CRE-2012.199-T
- Acronym
- AP-JD
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2012
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ko GT, So WY, Tong PC, Le Coguiec F, Kerr D, Lyubomirsky G, Tamesis B, Wolthers T, Nan J, Chan J. From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program. BMC Med Inform Decis Mak. 2010 May 13;10:26. doi: 10.1186/1472-6947-10-26.
PubMed 20465815Chan J, So W, Ko G, Tong P, Yang X, Ma R, Kong A, Wong R, Le Coguiec F, Tamesis B, Wolthers T, Lyubomirsky G, Chow P. The Joint Asia Diabetes Evaluation (JADE) Program: a web-based program to translate evidence to clinical practice in Type 2 diabetes. Diabet Med. 2009 Jul;26(7):693-9. doi: 10.1111/j.1464-5491.2009.02751.x.
PubMed 19573118Lim LL, Lau ESH, Fu AWC, Ray S, Hung YJ, Tan ATB, Chamnan P, Sheu WHH, Chawla MS, Chia YC, Chuang LM, Nguyen DC, Sosale A, Saboo BD, Phadke U, Kesavadev J, Goh SY, Gera N, Huyen Vu TT, Ma RCW, Lau V, Luk AOY, Kong APS, Chan JCN; Asia-Pacific JADE Study Group. Effects of a Technology-Assisted Integrated Diabetes Care Program on Cardiometabolic Risk Factors Among Patients With Type 2 Diabetes in the Asia-Pacific Region: The JADE Program Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e217557. doi: 10.1001/jamanetworkopen.2021.7557.
PubMed 33929522
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Program to Compare the Effect of the Joint Asia Diabetes Evaluation (JADE, Structured Care) Versus the DIAbetes MONitoring Database (DIAMOND, Usual Care) Programs in Type 2 Diabetes in the Asia Pacific Region
- ClinicalTrials.gov ID
- NCT01631084
- Acronym / sponsor ID
- AP-JD / CRE-2012.199-T
- Conditions
- Diabetes
- Keywords
- Diabetes, Structured care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,834 participants (actual)
- Lead sponsor
- Asia Diabetes FoundationUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Jun 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.
In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short) supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care) group.
All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter. Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a protocol based on risk stratification with predefined follow up (FU) schedules together with shared information and decision support (i.e. structured collaborative care). The DIAMOND protocol involves only baseline and yearly CA without predefined FU schedules or feedback of information between CA visits (i.e. usual care).
The primary composite endpoint is all-diabetes related clinical endpoints. The secondary composite endpoint is attainment of treatment goals and/or control of risk factors. The tertiary changes are behavioral changes, psychological well being and quality of life.
Detailed description
Rationale: Change of practice environment and an interdisciplinary team is needed to implement evidence-based diabetes care which requires risk stratification, periodic assessments, education and treatment to targets.
Hypothesis: The use of a web-based disease management program (Joint Asia Diabetes Evaluation (JADE) Program) delivered by a doctor-nurse-HCA team reduces the incidence of all diabetes-associated clinical endpoint and improves control of risk factors compared to usual care (DIAbetes MONitoring Database (DIAMOND) group) in type 2 diabetes.
Objective: To compare structured care using the JADE portal versus usual care using the DIAMOND portal on incidence of all-diabetes related events, physical and psychological health.
Study design: A multicentre, randomized, integrated disease management program Setting and patients: 600 patients from each site will be randomized to the JADE group (n=300) or the DIAMOND group (n=300) and followed up for at least 24 months.
Intervention: All patients will undergo comprehensive assessment (CA) guided by the templates in the respective portal at baseline, month 12 and 24. The JADE group will be further managed by a doctor-nurse-HCA team guided by the JADE portal with risk stratification program and recommendation to different care protocols with predefined follow up (FU) schedules, information sharing and decision supports.
Outcome measures: Primary composite outcomes include all diabetes-related clinical events; secondary composite outcomes include control of risk factors and tertiary composite outcomes include behavioral changes, psychological health, quality of life and cost-effective analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JADE | Experimental | Other: JADEPatients randomized to the JADE group will be followed according to protocol-driven diabetes care based on their individual risk levels, using a web-based disease management program. In addition to their annual comprehensive assessments at baseline, year 1 and year 2, all subsequent follow-up visits will be documented and entered into the JADE portal, which will then issue reports to both patients and doctor to promote sharing of information and informed decisions. |
| DIAMOND | Active comparator | Other: DIAMONDPatients will receive a comprehensive assessment at baseline, year 1 and year 2. In the interim between these time points patients will be managed according to 'usual care' procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetic patients who are willing or can be persuaded to return for 'regular' follow-up at 3-4 monthly intervals
- Patients with newly diagnosed or established disease, treated with lifestyle modification or blood glucose lowering drugs including oral agents with or without insulin
- For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be:
Key exclusion criteria (5 listed)
- Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
- Patients with reduced life expectancy (e.g. less than 6 months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life-threatening conditions
- Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
- Patients actively enrolled in another intervention study
- Patients who are unwilling to return for regular follow up.
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 |
|---|---|---|
| JADEPatients are booked for reviews led by the doctor-nurse-HCA team every 2-4 months, preferably in a setting different from the busy clinics in order to facilitate group education and promote peer support. Between each follow-up visit, the nurse or HCA will contact the patient by phone or email to remind them of the appointments (e.g. medical FU visit or laboratory tests), adhere to medications and healthy lifestyles, perform self glucose monitoring and provide psychosocial support, as appropriate. | Other | JADE |
| DIAMONDPatients randomized to the DIAMOND group will receive usual care after the initial baseline comprehensive assessment (CA), with repeat CA at 12 and 24 months. | Other | DIAMOND |
Primary outcome
Incidence of all diabetes-related clinical endpoints
Time frame: 12 months
1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) 2. chronic kidney disease (eGFR<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR<15 ml/min/1.73m2) 3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery 4. lower extremity amputation or foot ulcers requiring hospitalizations 5. major infections - pulmonary and non-pulmonary requiring hospitalizations 6. all-site cancers 7. death
1 secondary outcome
Proportions of patients with improved control of risk factors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 20465815Ko GT, So WY, Tong PC, Le Coguiec F, Kerr D, Lyubomirsky G, Tamesis B, Wolthers T, Nan J, Chan J. From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program. BMC Med Inform Decis Mak. 2010 May 13;10:26. doi: 10.1186/1472-6947-10-26.
- Background: PubMed 19573118Chan J, So W, Ko G, Tong P, Yang X, Ma R, Kong A, Wong R, Le Coguiec F, Tamesis B, Wolthers T, Lyubomirsky G, Chow P. The Joint Asia Diabetes Evaluation (JADE) Program: a web-based program to translate evidence to clinical practice in Type 2 diabetes. Diabet Med. 2009 Jul;26(7):693-9. doi: 10.1111/j.1464-5491.2009.02751.x.
- Derived from this study: PubMed 33929522Lim LL, Lau ESH, Fu AWC, Ray S, Hung YJ, Tan ATB, Chamnan P, Sheu WHH, Chawla MS, Chia YC, Chuang LM, Nguyen DC, Sosale A, Saboo BD, Phadke U, Kesavadev J, Goh SY, Gera N, Huyen Vu TT, Ma RCW, Lau V, Luk AOY, Kong APS, Chan JCN; Asia-Pacific JADE Study Group. Effects of a Technology-Assisted Integrated Diabetes Care Program on Cardiometabolic Risk Factors Among Patients With Type 2 Diabetes in the Asia-Pacific Region: The JADE Program Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e217557. doi: 10.1001/jamanetworkopen.2021.7557.
- Asia Diabetes Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 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 JADE and DIAMOND in people with Diabetes, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all diabetes-related clinical endpoints (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631084, which also lists 3 linked publications.
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 19 Apr 2022.