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

Primary Purpose

Diabetes Mellitus, Fasting, Diabetes Complications

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Focused education, medication adjustment and telemonitoring
Sponsored by
Sengkang General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - You 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 you 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.

Sites / Locations

  • Sengkang General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Focused education, medication adjustment and telemonitoring

Standard care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.

Full Information

First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Sengkang General Hospital
Collaborators
SingHealth Polyclinics, Singapore Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06033872
Brief Title
Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan
Official Title
Effectiveness of Diabetes Education and Medication Adjustment With Telemonitoring Intervention in Reducing Diabetes Complications During Ramadan Fasting - a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sengkang General Hospital
Collaborators
SingHealth Polyclinics, Singapore Clinical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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. You will be randomized to the intervention group comprising of focused diabetes education, medication adjustment and telemonitoring, and control group receiving standard care. You 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Fasting, Diabetes Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Focused education, medication adjustment and telemonitoring
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Combination Product
Intervention Name(s)
Focused education, medication adjustment and telemonitoring
Intervention Description
Focused diabetes education session for Ramadan fasting You 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 You will be provided regimen modified for Ramadan fasting. Telemonitoring You 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 Outcome Measure Information:
Title
a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan
Time Frame
30 day
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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.
Description
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
Time Frame
17 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - You 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 you 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sueziani B Zainudin, MBBS FRCPG
Organizational Affiliation
Sengkang General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sengkang General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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

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