Diabetes MellitusNCT06033872
Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan
A study testing Focused education, medication adjustment and telemonitoring in people with Diabetes Mellitus and Fasting, run by Sengkang General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Fasting, Diabetes Complications
- What is being tested?
- Focused education, medication adjustment and telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Jan 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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
- 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
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- 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.
Who cannot join
- -
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Focused education, medication adjustment and telemonitoring
- Medical subject headings
- Diabetes Mellitus, Fasting, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused education, medication adjustment and telemonitoringCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Focused education, medication adjustment and telemonitoring Receives: Combination Product: Focused education, medication adjustment and telemonitoring |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan
Measured: 30 day
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Jan 2021
- Primary completion1 Sep 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinics, Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Sueziani B Zainudin, MBBS FRCPG, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033872
- Sponsor's protocol ID
- 2019/2888
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diabetes Education and Medication Adjustment With Telemonitoring Intervention in Reducing Diabetes Complications During Ramadan Fasting - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06033872
- Acronym / sponsor ID
- 2019/2888
- Conditions
- Diabetes Mellitus, Fasting, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- SingHealth Polyclinics, Singapore Clinical Research Institute
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Combination Product: Focused education, medication adjustment and telemonitoringFocused education, medication adjustment and telemonitoring |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- 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
- 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
Key exclusion criteria (4 listed)
- -
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused education, medication adjustment and telemonitoring1. 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. | Combination product | Intervention |
Primary outcome
a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan
Time frame: 30 day
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sueziani B Zainudin, MBBS FRCPG principal investigator
Sengkang General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused education, medication adjustment and telemonitoring in people with Diabetes Mellitus and Fasting, run by Sengkang General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a. To compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.