NCT06043843

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
0mo left

Started Feb 2021

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Jun 2026

Study Start

First participant enrolled

February 16, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.3 years

First QC Date

September 5, 2023

Last Update Submit

September 12, 2023

Conditions

Diabetes MellitusFastingDiabetes Complications

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (5)

  • 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

    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

    12 weeks

  • Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan

    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

    12 weeks

  • Compare the weight changes after Ramadan as compared to pre-Ramadan weight

    12 weeks

Study Arms (2)

Focused structured tele-education, medication adjustment and remote monitoring

ACTIVE COMPARATOR
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

Standard Care

Interventions

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

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.

Focused structured tele-education, medication adjustment and remote monitoring

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sengkang General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusFastingDiabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehavior

Study Officials

  • Sueziani B Zainudin

    Sengkang General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Baskar Rajamanickam

CONTACT

69304463research@skh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 21, 2023

Study Start

February 16, 2021

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

SG(1)