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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 100
Healthy Volunteers: f
View:

• Adults with diabetes planning to fast in Ramadan,

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

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

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

⁃ 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

⁃ Ability to give informed consent,

⁃ Ability to perform self-monitoring blood glucose

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

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

Locations
Other Locations
Singapore
Sengkang General Hospital
RECRUITING
Singapore
Contact Information
Primary
Baskar Rajamanickam
research@skh.com.sg
69304463
Time Frame
Start Date: 2021-02-16
Estimated Completion Date: 2026-06
Participants
Target number of participants: 300
Treatments
Active_comparator: Focused structured tele-education, medication adjustment and remote monitoring
No_intervention: Control
Standard Care
Related Therapeutic Areas
Sponsors
Collaborators: Singapore General Hospital, Khoo Teck Puat Hospital, Universiti Teknologi Mara, University of Malaya, Universiti Kebangsaan Malaysia Medical Centre, Universiti Sains Malaysia, Changi General Hospital, Universiti Putra Malaysia
Leads: Sengkang General Hospital

This content was sourced from clinicaltrials.gov