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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
1. Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing 1. Fasting and exemptions 2. Self-monitoring of blood glucose 3. Acute diabetes complications and treatment 4. Ramadan nutritional plan 5. Safe physical activity You will be taught to record <!-- --> 1. Meal plans 2. Physical activities 3. Blood glucose monitoring, and 4. Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan. 2. Medication adjustments will be made according to the Diabetes and Ramadan Alliance guideline as well as individualized modifications based on their HbA1c as follows Baseline HbA1c Recommended dose reduction \< 8% 30% 8 to 10% 15% \> 10% None 2\) Glucose monitoring 1. up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week 2. uploaded into an online portal for data collection, without remote monitoring.
Sengkang General Hospital
Singapore, Singapore
RECRUITINGCompare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Time frame: 4 weeks
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
Time frame: 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
Time frame: 12 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Time frame: 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
Time frame: 12 weeks
Compare the weight changes after Ramadan as compared to pre-Ramadan weight
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.