Clinical trial NCT00499824: GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets
Official title: GIANT: General Practitioner Implementation in Asia of Normoglycaemic Targets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Management guidelines
Efficacy
Lead sponsor: International Diabetes Institute, Australia
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-07-11
Enrollment: 386
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5%
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 & 12 months
Other outcomes:
Locations:
city: Shatin
country: China
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong
state: Hong Kong
city: Beijing
country: China
facility: Department of Endocrinology & Metabolism, Peking University People's Hospital
city: Surabaya
country: Indonesia
facility: Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University,
city: Seoul
country: Korea, Republic of
facility: Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine
city: Johor Bahru
country: Malaysia
facility: School of Medicine and Health Sciences, Monash University House
city: Manila
country: Philippines
facility: Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine
city: Singapore
country: Singapore
facility: Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre
city: Taipei
country: Taiwan
facility: Dept of Medical Research and Education, Taipei Veterans General Hospital,
city: Bangkok
country: Thailand
facility: Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital,
city: Hanoi
country: Vietnam
facility: National Hospital of Endocrinology,
state: Dongda district
Study officials:
affiliation: International Diabetes Institute, Australia
name: Jonathan E Shaw, MD MRCP FRACP
role: PRINCIPAL_INVESTIGATOR
References: