NCT06043843

Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan

Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sengkang General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus
• Fasting
• Diabetes Complications

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram	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.

Timeline

• Start date: 2021-02-16
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Singapore