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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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).
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.
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:
Organisational changes to improve guideline adherence for the study will include:
Patient-centred approaches to improve guideline adherence for the study will include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Medical Practitioners who receive education on diabetes management following the guidelines of the International Diabetes Federation Western Pacific Region |
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| 2 | No Intervention | Medical practitioners who follow standard practice for management of their patients with type 2 diabetes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education of general practitioners on the IDF-WPR guidelines | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline in subjects with baseline HbA1c >/=6.5% | 6 months |
| Measure | Description | 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 |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan E Shaw, MD MRCP FRACP | International Diabetes Institute, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong | Shatin | Hong Kong | China | |||
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| Department of Endocrinology & Metabolism, Peking University People's Hospital |
| Beijing |
| 100044 |
| China |
| Diabetes and Nutrition Center, Dr. Soetomo Teaching Hospital - Airlangga University, | Surabaya | 60286 | Indonesia |
| School of Medicine and Health Sciences, Monash University House | Johor Bahru | 80100 | Malaysia |
| Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of the Philippines College of Medicine | Manila | Philippines |
| Diabetes, Lipid and Endocrine Practice, Gleneagles Medical Centre | Singapore | 258499 | Singapore |
| Department of Endocrinology & Metabolism, Kangnam St. Mary's Hospital, The Catholic University of Medicine | Seoul | South Korea |
| Dept of Medical Research and Education, Taipei Veterans General Hospital, | Taipei | Taiwan |
| Diabetes and Endocrinology Unit, Department of Medicine, Rajavithi Hospital, | Bangkok | 10400 | Thailand |
| National Hospital of Endocrinology, | Hanoi | Dongda District | Vietnam |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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