Clinical trial NCT06043843: Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan
Official title: Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Fasting
Diabetes Complications
Lead sponsor: Sengkang General Hospital
Sponsor class: OTHER
Collaborators: name: Universiti Putra Malaysia
name: Universiti Teknologi Mara
name: Universiti Kebangsaan Malaysia Medical Centre
name: University of Malaya
name: Universiti Sains Malaysia
name: Khoo Teck Puat Hospital
name: Singapore General Hospital
name: Changi General Hospital
First posted: 2023-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Adults with diabetes planning to fast in Ramadan,

  1. Adults with type 2 diabetes aged at least 21 years old,
  2. Able to fast at least 15 days in Ramadan based on experience of fasting in previous year's Ramadan,
  3. Underlying type 2 diabetes treated with basal insulin and one or more doses of prandial insulin, or at least twice-daily premixed insulin
  4. Performed laboratory tests as per standard care - glycated haemoglobin (HbA1c), serum Low Density Lipoprotein- cholesterol, serum triglycerides, serum High Density Lipoprotein- cholesterol, serum Total cholesterol and serum creatinine
  5. Ability to give informed consent,
  6. Ability to perform self-monitoring blood glucose
  7. Have had diabetes-related clinic visits or hospitalization in the past 10 months.
  8. Have the capacity for video conferencing (internet connection with mobile phone or computer)

Exclusion Criteria:

1. Severe diabetes complications including end-stage renal failure
2. Severe hypoglycemia and hyperglycemic crises within the last 3 months
3. Advanced comorbidities negating the ability to fast
4. Pregnancy
5. Patients on oral medications alone or oral medications plus basal insulin alone
6. Patients on sulfonylureas

Primary outcomes:
measure: Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
timeFrame: 4 weeks
Secondary outcomes:
measure: 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
timeFrame: 12 weeks
measure: Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions
timeFrame: 12 weeks
measure: Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
timeFrame: 4 weeks
measure: 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
timeFrame: 12 weeks
measure: Compare the weight changes after Ramadan as compared to pre-Ramadan weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
affiliation: Sengkang General Hospital
name: Sueziani B Zainudin
role: PRINCIPAL_INVESTIGATOR
References: