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

Sengkang General Hospital

Status: Enrolling

Conditions: Diabetes Complications; Diabetes Mellitus; Fasting

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06043843

2020/3137

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Focused structured tele-education, medication adjustment and remote monitoring

Active Comparator group

Treatment:

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

Control

No Intervention group

Description:

Standard Care