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GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets

NCT00499824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2010-05-04

No results posted yet for this study

Summary

To test whether the International Diabetes Federation - Western Pacific Region (IDF-WPR) Guidelines are more effective than standard practices in primary care (general practitioner) clinics for the management of type 2 diabetes mellitus (T2DM) in Asia. A 12-month multinational multicentre prospective cluster randomisation clinical trial within a primary care setting, with 2 parallel treatment arms: diabetes management using IDF-WPR guidelines versus standard clinic practices. 400 subjects will be recruited from 100 sites (4 subjects per site) in ten Asian countries (China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).

Conditions

Interventions

BEHAVIORAL

Education of general practitioners on the IDF-WPR guidelines

The intervention will comprise an educational program on the guidelines for GPs, and will be carried out by the national coordinating centre in each country, based on a template provided by the international coordinating centre (International Diabetes Institute, Australia). This will involve: an initial educational symposium and a follow-up continuing medical education symposium at 3 months; paper or electronic reminders of the guidelines sent to GPs every 3 months; desktop reminder cards with guideline algorithms; insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse; provision of each patient with a "diabetes passport" to be held by the patient.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • International Diabetes Institute, Australia

    lead OTHER

Principal Investigators

  • Jonathan E Shaw, MD MRCP FRACP · International Diabetes Institute, Australia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • China
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00499824 on ClinicalTrials.gov