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NCT Number: NCT06033872

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

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.

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Key information

Conditions

Diabetes Mellitus Behavior Diabetes Complications Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sengkang General Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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

  • Adults 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,
  • 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

  • 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
  • Most recent HbA1c level was >7.0% (>53mmol/mol)
  • Ability to give informed consent,
  • Ability to perform weekly recordings in the diary,
  • Able to use and owns a mobile phone for recordings on mobile application
  • 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:

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

Treatment and study plan

Focused education, medication adjustment and telemonitoring

Combination Product
  • Focused diabetes education session for Ramadan fasting

Participants will be taught to record

  • Meal plans
  • Physical activities
  • Blood glucose monitoring, and
  • Monitoring 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.

Primary outcomes

  1. a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan

    Time frame: 30 day

Secondary outcomes

  1. 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

    Time frame: 12 weeks

  2. 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

    Time frame: 12 weeks

  3. 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.

    Time frame: 17 weeks

    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

  4. 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.

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Sengkang General Hospital

Other

Collaborators

  • SingHealth Polyclinics
  • Singapore Clinical Research Institute

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 13, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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