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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
| Universiti Teknologi Mara | OTHER |
| Universiti Kebangsaan Malaysia Medical Centre | OTHER |
| University of Malaya |
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Introduction Diabetes is a global emergency with detrimental clinical and financial consequences. Poorly managed diabetes leads to a myriad of serious complications, especially cardiovascular and infectious complications, with consequent increased cost and mortality rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when diabetes control is essential. Adequate adjustments in diabetes management need to be made in line with the allowed mealtimes to avoid the risk of diabetes complications during Ramadan.
Objective Investigators aim to investigate the effectiveness of Ramadan-focused structured diabetes tele-education to reduce diabetes complications during Ramadan fasting for Muslims with diabetes in South East Asia.
Methodology In a parallel group randomized controlled trial, investigators aim to recruit 300 adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized to the intervention group comprising of a Ramadan-focused structured diabetes tele-education and control group receiving standard care. You will be reviewed again after Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department, hospital admissions, and compliance to recommendations for diabetes management during Ramadan.
Clinical Significance The study enables investigators to evaluate Ramadan-focused structured diabetes tele-education to reduce the risk of diabetes complications for a large population during the fasting month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused structured tele-education, medication adjustment and remote monitoring | Active Comparator |
| |
| Control | No Intervention | Standard Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram | Combination Product |
2) Glucose monitoring
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to 4 weeks before and 4 weeks post-Ramadan | 12 weeks | |
| Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions |
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Inclusion Criteria:
Adults with diabetes planning to fast in Ramadan,
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baskar Rajamanickam | Contact | 69304463 | research@skh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Sueziani B Zainudin | Sengkang General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
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| OTHER |
| Universiti Sains Malaysia | OTHER |
| Khoo Teck Puat Hospital | OTHER |
| Singapore General Hospital | OTHER |
| Changi General Hospital | OTHER |
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|
| 12 weeks |
| Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan | 4 weeks |
| Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of days of fast terminated in the event of hypoglycaemia or hyperglycemia | 12 weeks |
| Compare the weight changes after Ramadan as compared to pre-Ramadan weight | 12 weeks |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D005215 | Fasting |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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