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Establishing an International Diabetes Registry Using the DIabetes MONitoring Database (DIAMOND) Electronic Portal (HK012)(CN001)

This study is currently recruiting participants.
Verified June 2012 by Asia Diabetes Foundation
Sponsor:
Information provided by (Responsible Party):
Asia Diabetes Foundation
ClinicalTrials.gov Identifier:
NCT01274364
First received: January 9, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

Quality diabetes care requires a team approach and informed decisions of patients and care providers. Several lines of evidence suggests that a protocol-driven care model delivered by trained staff with focus on periodic assessments, reinforcement of patient compliance and attainment of multiple treatment targets reduces risk of cardio-renal complications and early death in type 2 diabetes.

The investigators hypothesize that the use of state of the art information technology to record, manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team.


Condition Intervention
Diabetes
 Other: JADE
Other: DIAMOND

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre Demonstration Project to Evaluate the Effectiveness and Acceptability of the Joint Asia Diabetes Evaluation (JADE) and DIAbetes MONitoring Database (DIAMOND) Programs in Asian Type 2 Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Asia Diabetes Foundation:

Primary Outcome Measures:
  • Percentage of patients who attain 2 or more of the 'ABC' targets [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Percentage of patients who attain 2 or more of the following 3 targets:

    • HbA1c <7%
    • BP <130/80 mmHg
    • LDL cholesterol <2.6 mmol/L


Secondary Outcome Measures:
  • New onset of all diabetes-related endpoints [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    This includes;

    • cardiovascular endpoints (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation or foot ulcers)
    • chronic kidney disease (eGFR<60 ml/min/1.73m2) and end stage renal disease (dialysis and/or eGFR<30 ; ml/min/1.73m2)
    • visual impairment (corrected visual acuity of 20/200 or lower) or eye surgery;
    • cancer
    • any hospitalization due to complications related to diabetes and/or its treatment (such as hypoglycaemic attacks)
    • death

  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency of hypoglycaemia (in the last 3 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Behavioral changes (in the last 3 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    1. Frequency of Self Blood Glucose Monitoring
    2. Adherence to balanced eating
    3. Adherence to regular exercise
    4. Adherence to recommended procedures (e.g. return for blood tests or education classes)

  • Number of hospitalizations, follow up visits by doctors and other care professionals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Default rates at end of study [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3600
Study Start Date: March 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JADE Other: JADE
Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will receive protocol-driven diabetes care using a web-based disease management program (JADE), delivered by a trio-team comprising of a trained doctor, nurse and physician assistant.
Active Comparator: DIAMOND Other: DIAMOND
Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will be managed according to 'usual care' procedures.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients attending hospitals or affiliated clinics led by PIs of the JADE Program who are living in the area with an intention to have 'regular' follow-up
  • Aged >18 years
  • Patients can have newly diagnosed or established disease, treated with lifestyle 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: a) Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or b) Random (or post-OGTT 2h) PG >11.1 mmol/L on 2 or more occasions, and/or c) HbA1c >6.5%

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274364

Contacts
Contact: Juliana Chan, MD 852 - 2632 3138 jchan@cuhk.edu.hk
Contact: Nicola Brown, MSc nicolabrown@adf.org.hk

Locations
Hong Kong
Asia Diabates Foundation Recruiting
Shatin, Hong Kong
Sponsors and Collaborators
Asia Diabetes Foundation
Investigators
Principal Investigator: Juliana Chan, MD Asia Diabetes Foundation
  More Information

Additional Information:
Works of the Asia Diabetes Foundation, including the DIAMOND program.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT01274364     History of Changes
Other Study ID Numbers: CRE-2010-112
Study First Received: January 9, 2011
Last Updated: June 19, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Asia Diabetes Foundation:
Diabetes
Structured Care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 18, 2012