Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan
NCT ID: NCT06033872
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2021-01-25
2022-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention
Focused education, medication adjustment and telemonitoring
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.
Control
Standard care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
100 Years
ALL
No
Sponsors
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SingHealth Polyclinics
OTHER
Singapore Clinical Research Institute
OTHER
Sengkang General Hospital
OTHER
Responsible Party
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Principal Investigators
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Sueziani B Zainudin, MBBS FRCPG
Role: PRINCIPAL_INVESTIGATOR
Sengkang General Hospital
Locations
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Sengkang General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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2019/2888
Identifier Type: -
Identifier Source: org_study_id