Comparing the Effect of Structured Care Versus Usual Care in Type 2 Diabetes Patients Across the Asia Pacific Region

NCT01631084 | Completed DMC

• 1 other identifier: CRE-2012.199-T
• Study Type: interventional
• Target: 20,834
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes

Keywords

Diabetes; Structured care

Outcome Measures

Primary Outcomes (1)

• Incidence of all diabetes-related clinical endpoints

  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

  12 months

Secondary Outcomes (1)

• Proportions of patients with improved control of risk factors

  12 months

Study Arms (2)

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.

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.

Other: DIAMOND

Interventions

JADE OTHER

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.

JADE

DIAMOND OTHER

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.

DIAMOND

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asia Diabetes Foundation: lead

Study Sites (1)

Asia Diabetes Foundation

Shatin, Hong Kong

Location

Related Publications (3)

• 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.

  PMID: 20465815 BACKGROUND

• Chan 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.

  PMID: 19573118 BACKGROUND

• Lim 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.

  PMID: 33929522 DERIVED

Related Links

• Asia Diabetes Foundation website

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diamond

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Juliana Chan, MD

  Asia Diabetes Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 28, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)