GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets (GIANT)

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Education of general practitioners on the IDF-WPR guidelines

Detailed Description

Description of intervention(s) / exposure and control treatment: This is a prospective multinational, multicentre, cluster-randomised study conducted within the primary care setting, with two parallel treatment arms: standard clinical practice versus education on diabetes management using International Diabetes Federation - Western Pacific Region (IDF-WPR) "Type 2 diabetes practical targets and treatments". The study duration will be 12 months.

100 General Practitioners (GPs) (10 per country) will be randomised to receive education on the IDF-WPR guidelines or to receive no trial-related education.

• GPs in both groups will be required to recruit 4 of their own patients meeting the eligibility criteria. The complete entry criteria are detailed in a following section.
• GPs in both groups will manage the recruited patients according to their own clinical judgement. Frequency of patient visits to the GP's clinic will be determined by the GP. All medication prescribed by the GPs should already be registered in the participating countries.
• Blood sampling of patients will be required at Study Visit 1 (Screening/Baseline), Study Visit 2 (month 6) and Study Visit 3 (month 12).

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). The educational program for the GPs randomised to the intervention arm will:

1. Combine didactic and interactive sessions.
2. Involve opinion leaders, i.e. the national lead investigator
3. Aim to resolve barriers to practical implementation of guidelines already identified from previous studies (e.g. discuss starting insulin)
4. Present the evidence for the guidelines.
5. Highlight any conflicts between the guidelines and local prescribing regulations, and confirm the need to follow the local prescribing regulations in these instances
6. Involve an initial educational symposium and a follow-up continuing medical education symposium at 3 months

Organisational changes to improve guideline adherence for the study will include:

1. Paper or electronic reminders of the guidelines will be sent to GPs every 3 months.
2. Desktop reminders cards with key guideline algorithms.
3. Insertion of a flowsheet (diabetes action plan) into the patient's medical notes by the study nurse (at the time of review of the practitioner's baseline HbA1c utilisation).

Patient-centred approaches to improve guideline adherence for the study will include:

1. Encouragement and empowerment of patients to ask questions of the treating practitioners
2. Provision of each patient with a "diabetes passport" to be held by the patient, to encourage discussion between the patient and practitioner and also recording of results of medical examinations. This will be provided at the baseline visit to the national coordinating centre.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100044
    • Department of Endocrinology & Metabolism, Peking University People's Hospital
  • Hong Kong
    • Shatin, Hong Kong, China
      • Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong
• Indonesia
  • Surabaya, Indonesia, 60286
    • Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University,
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • School of Medicine and Health Sciences, Monash University House
• Philippines
  • Manila, Philippines
    • Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine
• Singapore
  • Singapore, Singapore, 258499
    • Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre
• Taiwan
  • Taipei, Taiwan
    • Dept of Medical Research and Education, Taipei Veterans General Hospital,
• Thailand
  • Bangkok, Thailand, 10400
    • Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital,
• Vietnam
  • Dongda district
    • Hanoi, Dongda district, Vietnam
      • National Hospital of Endocrinology,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

• Men or women who are 30 to 75 years of age (inclusive) at Study Visit 1.
• Clinical diagnosis of type 2 diabetes (defined according to IDF Guidelines) for a minimum of 6 months prior to Study Visit 1
• Patients for whom the GP is the primary medical provider of diabetes care and for whom referral to another doctor for diabetes care is not anticipated within 3 months of Study Visit 1
• Patients who give informed consent to participate.

EXCLUSION CRITERIA

• Patients with type 1 diabetes mellitus
• Patients with any previous episode of ketoacidosis
• Patients who required chronic use (>/= 6 months) of insulin at any time in the past, with the exception of females during pregnancy
• Patients receiving insulin treatment at Study Visit 1 or within the previous 6 months, with the exception of patients who received short-term treatment (= 7 days) with insulin to maintain glycaemic control for an acute event (e.g. hospitalisation or medical procedure/intervention, infection or trauma).
• Treatment with glucocorticoid at Study Visit 1 or within the previous 6 months, with the exception of topical or inhaled glucocorticoid
• Females who are pregnant or considering pregnancy or stopping contraception within the course of the study
• Patients with end-stage renal disease, defined as glomerular filtration rate (GFR) by the MDRD (Modification of Diet in Renal Disease) formula < 15 ml/min/1.73 m2, or on renal replacement therapy with haemodialysis, peritoneal dialysis or renal transplant.
• Patients with psychiatric disease, active drug or alcohol abuse or other cognitive impairment that may interfere with treatment compliance.
• Receipt of any investigational drug within 30 days of Study Visit 1.
• Patients receiving diabetes care from another doctor (specialist endocrinologist, general physician, or another GP) Other eligibility criteria considerations The HbA1c at entry for newly recruited patients will be monitored centrally. If there is a significant risk that more than 25% of the total study population will have a baseline HbA1c </= 6.5%, then recruitment of subsequent patients will be restricted to those with HbA1c > 6.5%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Medical Practitioners who receive education on diabetes management following the guidelines of the International Diabetes Federation Western Pacific Region	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.
No Intervention: 2; Medical practitioners who follow standard practice for management of their patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5%	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
HbA1c, FPG, BP, lipids; hypoglycemic events; health care use; number of GP HbA1c measurements; number of treatment escalations; adverse events; barriers to guideline implementation; determine if study patients are representative of GP's diabetic practice	6 & 12 months

Collaborators and Investigators

• Sponsor: International Diabetes Institute, Australia
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Jonathan E Shaw, MD MRCP FRACP, International Diabetes Institute, Australia

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: July 9, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 11, 2007

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes; Efficacy; Management guidelines
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IDI Project 4/2006