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

NCT ID: NCT06043843

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Focused structured tele-education, medication adjustment and remote monitoring

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: COMBINATION_PRODUCT

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

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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.

Control

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: collaborator

Universiti Teknologi Mara

OTHER

Sponsor Role: collaborator

Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: collaborator

Khoo Teck Puat Hospital

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: collaborator

Changi General Hospital

OTHER

Sponsor Role: collaborator

Sengkang General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sueziani B Zainudin

Role: PRINCIPAL_INVESTIGATOR

Sengkang General Hospital

Locations

Sengkang General Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Baskar Rajamanickam

Role: CONTACT

research@skh.com.sg

69304463

Facility Contacts

Baskar Rajamanicka

Role: primary

69304463

Other Identifiers

2020/3137

Identifier Type: -

Identifier Source: org_study_id