Actively Recruiting
Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan
Led by Sengkang General Hospital · Updated on 2023-09-21
300
Participants Needed
1
Research Sites
275 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
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
Official 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 21 years or older
- Able to fast at least 15 days during Ramadan based on previous experience
- Treated with basal insulin plus one or more doses of prandial insulin, or at least twice-daily premixed insulin
- Have completed standard laboratory tests including HbA1c, cholesterol panels, and serum creatinine
- Able to give informed consent
- Able to perform self-monitoring of blood glucose
- Have had diabetes-related clinic visits or hospitalizations in the past 10 months
- Have capacity for video conferencing using a mobile phone or computer with internet
You will not qualify if you...
- Severe diabetes complications such as end-stage renal failure
- Severe hypoglycemia or hyperglycemic crises within the last 3 months
- Advanced health conditions preventing fasting
- Pregnancy
- Currently using only oral diabetes medications or oral medications plus basal insulin alone
- Using sulfonylurea medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sengkang General Hospital
Singapore, Singapore
Actively Recruiting
Research Team
B
Baskar Rajamanickam
CONTACT
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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