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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
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
Combination product1. Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing 1. Fasting and exemptions 2. Self-monitoring of blood glucose 3. Acute diabetes complications and treatment 4. Ramadan nutritional plan 5. Safe physical activity You will be taught to record <!-- --> 1. Meal plans 2. Physical activities 3. Blood glucose monitoring, and 4. Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan. 2. Medication adjustments will be made according to the Diabetes and Ramadan Alliance guideline as well as individualized modifications based on their HbA1c as follows Baseline HbA1c Recommended dose reduction \< 8% 30% 8 to 10% 15% \> 10% None 2\) Glucose monitoring 1. up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week 2. uploaded into an online portal for data collection, without remote monitoring.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Focused structured tele-education, medication adjustment and remote monitoringActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Time frame
4 weeksSecondary outcomes
1
Compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to 4 weeks before and 4 weeks post-Ramadan
Time frame
12 weeks2
Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions
Time frame
12 weeks3
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Time frame
4 weeks4
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of days of fast terminated in the event of hypoglycaemia or hyperglycemia
Time frame
12 weeksSponsors and contacts
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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
Source ClinicalTrials.gov