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

Primary Purpose

Diabetes Mellitus, Fasting, Diabetes Complications

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Ability to give informed consent, Ability to perform self-monitoring blood glucose Have had diabetes-related clinic visits or hospitalization in the past 10 months. Have the capacity for video conferencing (internet connection with mobile phone or computer) Exclusion Criteria: 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 Patients on oral medications alone or oral medications plus basal insulin alone Patients on sulfonylureas

Sites / Locations

  • Sengkang General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Focused structured tele-education, medication adjustment and remote monitoring

Control

Arm Description

Standard Care

Outcomes

Primary Outcome Measures

Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan

Secondary Outcome Measures

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
Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
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
Compare the weight changes after Ramadan as compared to pre-Ramadan weight

Full Information

First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Sengkang General Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT06043843
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sengkang General Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Fasting, Diabetes Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focused structured tele-education, medication adjustment and remote monitoring
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard Care
Intervention Type
Combination Product
Intervention Name(s)
Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram
Intervention Description
Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing Fasting and exemptions Self-monitoring of blood glucose Acute diabetes complications and treatment Ramadan nutritional plan Safe physical activity You will be taught to record Meal plans Physical activities Blood glucose monitoring, and Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan. 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 up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week uploaded into an online portal for data collection, without remote monitoring.
Primary Outcome Measure Information:
Title
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Time Frame
4 weeks
Title
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
Title
Compare the weight changes after Ramadan as compared to pre-Ramadan weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Ability to give informed consent, Ability to perform self-monitoring blood glucose Have had diabetes-related clinic visits or hospitalization in the past 10 months. Have the capacity for video conferencing (internet connection with mobile phone or computer) Exclusion Criteria: 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 Patients on oral medications alone or oral medications plus basal insulin alone Patients on sulfonylureas
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baskar Rajamanickam
Phone
69304463
Email
research@skh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sueziani B Zainudin
Organizational Affiliation
Sengkang General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sengkang General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baskar Rajamanicka
Phone
69304463
First Name & Middle Initial & Last Name & Degree
Rohana Abdul Ghani
First Name & Middle Initial & Last Name & Degree
Nisak Barakatun
First Name & Middle Initial & Last Name & Degree
Norlaila Mustafa
First Name & Middle Initial & Last Name & Degree
Zanariah Hussein
First Name & Middle Initial & Last Name & Degree
Ester Yeoh
First Name & Middle Initial & Last Name & Degree
Hong Chang Tan
First Name & Middle Initial & Last Name & Degree
Wanling Zeng

12. IPD Sharing Statement

Learn more about this trial

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

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