Actively Recruiting
Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia
Led by Sengkang General Hospital · Updated on 2023-09-21
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sengkang General Hospital
Lead Sponsor
U
Universiti Putra Malaysia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetes is a serious global health issue with many complications, especially during the fasting month of Ramadan for Muslims. This trial evaluates a Ramadan-focused structured diabetes tele-education program to help reduce diabetes complications during Ramadan fasting among adults with type 2 diabetes in South East Asia. Researchers aim to understand if this education can lower the risk of hypoglycemia and other diabetes-related problems during Ramadan. Participants will be randomly assigned to one of two groups: an intervention group receiving Ramadan-focused tele-education and medication adjustments based on guidelines, along with remote monitoring, and a control group receiving standard care. The tele-education includes online sessions on fasting rules, blood glucose monitoring, managing diabetes complications, nutrition, and safe exercise. Participants will also try a fasting trial day before Ramadan, and their medication doses will be adjusted according to their HbA1c levels. During the study, participants will track their blood glucose up to four times daily before, during, and after Ramadan and upload the data online. Researchers will monitor the occurrence of hypoglycemia and other diabetes complications, clinic visits, hospital admissions, and adherence to diabetes management recommendations. Weight changes and fasting compliance will also be assessed. The study follows participants through Ramadan and for several weeks afterwards to evaluate outcomes and safety.
CONDITIONS
Brief Title
Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with type 2 diabetes aged at least 21 years old
- Planning to fast at least 15 days during Ramadan based on previous fasting experience
- Using basal insulin with one or more doses of prandial insulin, or at least twice-daily premixed insulin
- Completed standard laboratory tests including HbA1c, cholesterol levels, and serum creatinine
- Able to give informed consent
- Able to perform self-monitoring of blood glucose
- Had diabetes-related clinic visits or hospitalization within the past 10 months
- Have access to video conferencing via internet with mobile phone or computer
You will not qualify if you...
- Severe diabetes complications including end-stage renal failure
- Severe hypoglycemia or hyperglycemic crises within the last 3 months
- Advanced health conditions preventing fasting
- Pregnancy
- Using only oral medications or oral medications plus basal insulin alone
- Taking sulfonylurea medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks including 4 weeks before, 4 weeks during, and 4 weeks after Ramadan
Participants receive Ramadan-focused online education and medication adjustments with remote monitoring. They will be educated on fasting, self-monitoring blood glucose, diabetes complications, nutrition, and safe physical activity. Participants perform a trial fasting day prior to Ramadan and adjust medications according to guidelines based on their HbA1c. Glucose monitoring is done up to 4 times daily before, during, and after Ramadan.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Sengkang General Hospital
Singapore, Singapore
Actively Recruiting
Research Team
B
Baskar Rajamanickam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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