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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043843
• Other study ID #: 2020/3137
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Sengkang General Hospital
• Contact: Baskar Rajamanickam
• Phone: 69304463
• Email: research[@]skh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults with diabetes planning to fast in Ramadan,

1. Adults with type 2 diabetes aged at least 21 years old,

2. Able to fast at least 15 days in Ramadan based on experience of fasting in previous year's Ramadan,

3. Underlying type 2 diabetes treated with basal insulin and one or more doses of prandial insulin, or at least twice-daily premixed insulin

4. Performed laboratory tests as per standard care - glycated haemoglobin (HbA1c), serum Low Density Lipoprotein- cholesterol, serum triglycerides, serum High Density Lipoprotein- cholesterol, serum Total cholesterol and serum creatinine

5. Ability to give informed consent,

6. Ability to perform self-monitoring blood glucose

7. Have had diabetes-related clinic visits or hospitalization in the past 10 months.

8. Have the capacity for video conferencing (internet connection with mobile phone or computer)

Exclusion Criteria:

1. Severe diabetes complications including end-stage renal failure

2. Severe hypoglycemia and hyperglycemic crises within the last 3 months

3. Advanced comorbidities negating the ability to fast

4. Pregnancy

5. Patients on oral medications alone or oral medications plus basal insulin alone

6. Patients on sulfonylureas

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Fasting

Intervention

Combination Product:
• Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram
Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing Fasting and exemptions Self-monitoring of blood glucose Acute diabetes complications and treatment Ramadan nutritional plan Safe physical activity You will be taught to record Meal plans Physical activities Blood glucose monitoring, and Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan. 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 up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week uploaded into an online portal for data collection, without remote monitoring.

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore

Sponsors (9)

Lead Sponsor	Collaborator
Sengkang General Hospital	Changi General Hospital, Khoo Teck Puat Hospital, Singapore General Hospital, Universiti Kebangsaan Malaysia Medical Centre, Universiti Putra Malaysia, Universiti Sains Malaysia, Universiti Teknologi Mara, University of Malaya

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan		4 weeks
Secondary	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
Secondary	Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions		12 weeks
Secondary	Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan		4 weeks
Secondary	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
Secondary	Compare the weight changes after Ramadan as compared to pre-Ramadan weight		12 weeks