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Establishing a Diabetes Registry Using the JADE-DIAMOND Electronic Portal (CN001) (China-JD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274364
First Posted: January 11, 2011
Last Update Posted: March 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asia Diabetes Foundation
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: China-JD Program: 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

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 ]

    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 ]

    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 ]
  • Frequency of hypoglycaemia (in the last 3 months) [ Time Frame: 12 months ]
  • Behavioral changes (in the last 3 months) [ Time Frame: 12 months ]
    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 ]
  • Default rates at end of study [ Time Frame: 12 months ]

Enrollment: 3586
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274364


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT01274364     History of Changes
Other Study ID Numbers: CRE-2010-112
First Submitted: January 9, 2011
First Posted: January 11, 2011
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by Asia Diabetes Foundation:
Diabetes
Structured Care

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