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

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ClinicalTrials.gov Identifier: NCT06043843
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborators:
Universiti Putra Malaysia
Universiti Teknologi Mara
Universiti Kebangsaan Malaysia Medical Centre
University of Malaya
Universiti Sains Malaysia
Khoo Teck Puat Hospital
Singapore General Hospital
Changi General Hospital
Information provided by (Responsible Party):
Sengkang General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Fasting Diabetes Complications Combination Product: Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 weeks ]
  2. 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 ]
  3. Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan [ Time Frame: 4 weeks ]
  4. 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 ]
  5. Compare the weight changes after Ramadan as compared to pre-Ramadan weight [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043843


Contacts
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Contact: Baskar Rajamanickam 69304463 research@skh.com.sg

Locations
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Singapore
Sengkang General Hospital Recruiting
Singapore, Singapore
Contact: Baskar Rajamanicka    69304463      
Principal Investigator: Rohana Abdul Ghani         
Principal Investigator: Nisak Barakatun         
Principal Investigator: Norlaila Mustafa         
Principal Investigator: Zanariah Hussein         
Sub-Investigator: Ester Yeoh         
Sub-Investigator: Hong Chang Tan         
Sub-Investigator: Wanling Zeng         
Sponsors and Collaborators
Sengkang General Hospital
Universiti Putra Malaysia
Universiti Teknologi Mara
Universiti Kebangsaan Malaysia Medical Centre
University of Malaya
Universiti Sains Malaysia
Khoo Teck Puat Hospital
Singapore General Hospital
Changi General Hospital
Investigators
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Principal Investigator: Sueziani B Zainudin Sengkang General Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sengkang General Hospital
ClinicalTrials.gov Identifier: NCT06043843    
Other Study ID Numbers: 2020/3137
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases