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

September 12, 2023 updated by: Sengkang General Hospital

Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Sengkang General Hospital
        • Sub-Investigator:
          • Hong Chang Tan
        • Contact:
          • Baskar Rajamanicka
          • Phone Number: 69304463
        • Principal Investigator:
          • Rohana Abdul Ghani
        • Principal Investigator:
          • Nisak Barakatun
        • Principal Investigator:
          • Norlaila Mustafa
        • Principal Investigator:
          • Zanariah Hussein
        • Sub-Investigator:
          • Ester Yeoh
        • Sub-Investigator:
          • Wanling Zeng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Focused structured tele-education, medication adjustment and remote monitoring
Combination product: Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram

  1. 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.
No Intervention: Control
Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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 weeks
12 weeks
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 weeks
12 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Time Frame: 4 weeks
4 weeks
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 weeks
12 weeks
Compare the weight changes after Ramadan as compared to pre-Ramadan weight
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sengkang General Hospital

Collaborators

Universiti Putra Malaysia
University of Malaya
Khoo Teck Puat Hospital
Singapore General Hospital
Universiti Kebangsaan Malaysia Medical Centre
Changi General Hospital
Universiti Sains Malaysia
Universiti Teknologi Mara

Investigators

  • Principal Investigator: Sueziani B Zainudin, Sengkang General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/3137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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