Actively Recruiting

Phase Not Applicable
Age: 21Years - 100Years
All Genders
NCT06043843

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

Age: 21Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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