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

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 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.

Conditions

• Diabetes Mellitus
• Fasting
• Diabetes Complications

Interventions

COMBINATION_PRODUCT

Focused education, medication adjustment and telemonitoring

1. Focused diabetes education session for Ramadan fasting Participants will be taught to record 1. Meal plans 2. Physical activities 3. Blood glucose monitoring, and 4. Monitoring for diabetes complications. Then perform a trial fasting day prior to Ramadan when control is not optimal or medication with risk of hypoglycemia. 2. Medication adjustment for Ramadan fasting Participants will be provided regimen modified for Ramadan fasting. 3. 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.

Sponsors & Collaborators

• SingHealth Polyclinics

  collaborator OTHER

• Singapore Clinical Research Institute

  collaborator OTHER

• Sengkang General Hospital

  lead OTHER

Principal Investigators

• Sueziani B Zainudin, MBBS FRCPG · Sengkang General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2021-09-01

Completion

2022-05-31

Countries

• Singapore

Study Locations