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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-100
SponsorSengkang General Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Severe diabetes complications including end-stage renal failure

Severe hypoglycemia and hyperglycemic crises within the last 3 months

Advanced comorbidities negating the ability to fast

Pregnancy

Trial design

Treatments tested in this trial

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

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sengkang General Hospital

Lead sponsor

Universiti Putra Malaysia

Collaborator

Universiti Teknologi Mara

Collaborator

Universiti Kebangsaan Malaysia Medical Centre

Collaborator

University of Malaya

Collaborator

Universiti Sains Malaysia

Collaborator

Khoo Teck Puat Hospital

Collaborator

Singapore General Hospital

Collaborator

Changi General Hospital

Collaborator