Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan

Effectiveness of Diabetes Education and Medication Adjustment With Telemonitoring Intervention in Reducing Diabetes Complications During Ramadan Fasting - a Randomized Control Trial

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 meal times to avoid the risk of diabetes complications during Ramadan.

Objective Investigators aim to investigate the effectiveness of focused diabetes education and medication adjustment with telemonitoring to reduce diabetes complications during Ramadan fasting as well as to assess the cost-effectiveness of this intervention for Muslims with diabetes in Singapore.

Methodology In a parallel group randomized controlled trial, investigators aim to recruit 100 adults with diabetes who are able to fast at least 15 days in Ramadan. Participants will be randomized to the intervention group comprising of focused diabetes education, medication adjustment and telemonitoring, and control group receiving standard care. Participants will be followed up during Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are (i) incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department and that of hospital admission, and (ii) cost-effectiveness of the intervention.

Clinical Significance The study enables investigators to evaluate focused pre-Ramadan diabetes education and medication adjustment with tele-monitoring as a means to reduce the markedly increased risk of diabetes complications for a large population during the fasting month, with potential for increased cost-effectiveness through reducing unscheduled attendances at clinic and hospital.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Diabetes Complications; Fasting
• Intervention / Treatment: Combination product: Focused education, medication adjustment and telemonitoring

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Sengkang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-

Participants must meet all of the inclusion criteria to participate in this study:

1. Adults 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. Known physician-diagnosed diabetes mellitus (DM) based on the following criteria before starting treatment

   a. Symptoms of polyuria, polydipsia and unexplained weight loss with i. fasting glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1 mmol/l or iii. 2-hour post 75g oral glucose challenge test plasma glucose ≥ 11.1 mmol/l b. Absence of symptoms of polyuria, polydipsia and unexplained weight loss with the following tests done twice showing the values i. fasting glucose ≥ 7.0mmol/l or ii. random plasma glucose ≥ 11.1 mmol/l or iii. 2-hour post 75g oral glucose challenge test plasma glucose ≥ 11.1 mmol/l

4. Performed laboratory tests as per standard care : serum glycated hemoglobin A1c (HbA1c) level, blood Low Density Lipoprotein-Cholesterol, blood triglyceride level, blood High Density Lipoprotein-Cholesterol, blood Total Cholesterol and serum creatinine
5. Most recent HbA1c level was >7.0% (>53mmol/mol)
6. Ability to give informed consent,
7. Ability to perform weekly recordings in the diary,
8. Able to use and owns a mobile phone for recordings on mobile application
9. Should have had DM-related clinic visits or hospitalization in the past 10 months.

Exclusion Criteria:

-

Meeting any of the exclusion criteria at baseline will exclude participants from participation:

1. Severe diabetes complications including end-stage renal failure, severe hypoglycemia and hyperglycemic crises within the last 1 month negating ability to fast,
2. Pregnancy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care
Active Comparator: Intervention; Focused education, medication adjustment and telemonitoring	Combination product: Focused education, medication adjustment and telemonitoring; Focused diabetes education session for Ramadan fastingParticipants will be taught to recordMeal plansPhysical activitiesBlood glucose monitoring, andMonitoring for diabetes complications. Then perform a trial fasting day prior to Ramadan when control is not optimal or medication with risk of hypoglycemia.; Medication adjustment for Ramadan fasting Participants will be provided regimen modified for Ramadan fasting.; Telemonitoring Participants will be taught to perform blood glucose monitoring 4 times daily using a glucometer and upload recordings of glucose levels onto the data software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
i. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to before and after Ramadan		12 weeks
ii. To compare the first incidence rate of complications in Ramadan when compared to before and after 1. Hyperglycemia and crises 2. Acute infections, clinic and emergency department attendances and hospital admissions		12 weeks
Health-related Quality-of-Life using European Quality of Life Five Dimensions (EQ-5D) - to provide a summary of index value of health and health change, cost-utility calculation.	Five dimensions are mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Scored health as 0 to 100 where 0 is worst and 100 is best	17 weeks
Healthcare utilizations costs - Medical services, drugs and devices utilized, outpatient and inpatient visits, cost of intervention sessions, telemonitoring and equipment, indirect costs related to health care utilisation, and caregiver costs.		17 weeks

Collaborators and Investigators

• Sponsor: Sengkang General Hospital
• Collaborators: Singapore Clinical Research Institute; SingHealth Polyclinics
• Investigators: Principal Investigator: Sueziani B Zainudin, MBBS FRCPG, Sengkang General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Complications
• Other Study ID Numbers: 2019/2888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No