Diabetes MellitusNCT06043843
Effectiveness of Focused Tele-education in Reducing Diabetes Complications During Ramadan
A study testing Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram 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 diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 16 Feb 2021to Jun 2026
- 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
- Adults with diabetes planning to fast in Ramadan,
- Adults with type 2 diabetes 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,
- Underlying type 2 diabetes treated with basal insulin and one or more doses of prandial insulin, or at least twice-daily premixed insulin
- Performed laboratory tests as per standard care - glycated haemoglobin (HbA1c), serum Low Density Lipoprotein- cholesterol, serum triglycerides, serum High Density Lipoprotein- cholesterol, serum Total cholesterol and serum creatinine
- Ability to give informed consent,
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- Ability to perform self-monitoring blood glucose
- Have had diabetes-related clinic visits or hospitalization in the past 10 months.
- Have the capacity for video conferencing (internet connection with mobile phone or computer)
Who cannot join
- Severe diabetes complications including end-stage renal failure
- Severe hypoglycemia and hyperglycemic crises within the last 3 months
- Advanced comorbidities negating the ability to fast
- Pregnancy
- Patients on oral medications alone or oral medications plus basal insulin alone
- Patients on sulfonylureas
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore
Baskar Rajamanicka, 69304463
Rohana Abdul Ghani
About this study
Official title: Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia
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 mealtimes to avoid the risk of diabetes complications during Ramadan.
Objective Investigators aim to investigate the effectiveness of Ramadan-focused structured diabetes tele-education to reduce diabetes complications during Ramadan fasting for Muslims with diabetes in South East Asia.
Read more
Methodology In a parallel group randomized controlled trial, investigators aim to recruit 300 adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized to the intervention group comprising of a Ramadan-focused structured diabetes tele-education and control group receiving standard care. You will be reviewed again after Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department, hospital admissions, and compliance to recommendations for diabetes management during Ramadan.
Clinical Significance The study enables investigators to evaluate Ramadan-focused structured diabetes tele-education to reduce the risk of diabetes complications for a large population during the fasting month.
- Conditions
- Diabetes Mellitus, Fasting, Diabetes Complications
- Being tested
- Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram
- 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 diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout RamCombination product
- Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing
- Fasting and exemptions
- Self-monitoring of blood glucose
- Acute diabetes complications and treatment
- Ramadan nutritional plan
- Safe physical activity You will be taught to record <!-- -->
- Meal plans
- Physical activities
- Blood glucose monitoring, and
- Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan.
- Medication adjustments will be made according to the Diabetes and Ramadan Alliance guideline as well as individualized modifications based on their HbA1c as follows Baseline HbA1c Recommended dose reduction < 8% 30% 8 to 10% 15% > 10% None
- Glucose monitoring
- up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week
- uploaded into an online portal for data collection, without remote monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Focused structured tele-education, medication adjustment and remote monitoring | Active comparator | Not described Receives: Combination Product: Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram |
| Control | No intervention | Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Measured: 4 weeks
Secondary outcomes (5)
Compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to 4 weeks before and 4 weeks post-Ramadan
Measured: 12 weeks
Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions
Measured: 12 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Measured: 4 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of days of fast terminated in the event of hypoglycaemia or hyperglycemia
Measured: 12 weeks
Compare the weight changes after Ramadan as compared to pre-Ramadan weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 Feb 2021
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sengkang General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia, Universiti Teknologi Mara, Universiti Kebangsaan Malaysia Medical Centre, University of Malaya, Universiti Sains Malaysia, Khoo Teck Puat Hospital, Singapore General Hospital, Changi General Hospital
- Responsible party
- Sponsor
- Investigators
- Sueziani B Zainudin, Principal investigator, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043843
- Sponsor's protocol ID
- 2020/3137
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Ramadan-focused Structured Diabetes Tele-education in Reducing Diabetes Complications During Ramadan Fasting in South East Asia
- ClinicalTrials.gov ID
- NCT06043843
- Acronym / sponsor ID
- 2020/3137
- Conditions
- Diabetes Mellitus, Fasting, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sengkang General HospitalUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia, Universiti Teknologi Mara, Universiti Kebangsaan Malaysia Medical Centre, University of Malaya, Universiti Sains Malaysia, Khoo Teck Puat Hospital, Singapore General Hospital, Changi General Hospital
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 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 mealtimes to avoid the risk of diabetes complications during Ramadan.
Objective Investigators aim to investigate the effectiveness of Ramadan-focused structured diabetes tele-education to reduce diabetes complications during Ramadan fasting for Muslims with diabetes in South East Asia.
Methodology In a parallel group randomized controlled trial, investigators aim to recruit 300 adults with diabetes who are able to fast at least 15 days in Ramadan. You will be randomized to the intervention group comprising of a Ramadan-focused structured diabetes tele-education and control group receiving standard care. You will be reviewed again after Ramadan. The primary outcome is the incidence of hypoglycemia in Ramadan. The secondary outcomes are incidence of other diabetes complications in Ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department, hospital admissions, and compliance to recommendations for diabetes management during Ramadan.
Clinical Significance The study enables investigators to evaluate Ramadan-focused structured diabetes tele-education to reduce the risk of diabetes complications for a large population during the fasting month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused structured tele-education, medication adjustment and remote monitoring | Active comparator | Combination Product: Focused diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram |
| 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 (9 listed)
- Adults with diabetes planning to fast in Ramadan,
Key exclusion criteria (6 listed)
- Severe diabetes complications including end-stage renal failure
- Severe hypoglycemia and hyperglycemic crises within the last 3 months
- Advanced comorbidities negating the ability to fast
- Pregnancy
- Patients on oral medications alone or oral medications plus basal insulin alone
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 diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram1. Ramadan-focused online education by physician, specialist nurse, and dietitian via video conferencing 1. Fasting and exemptions 2. Self-monitoring of blood glucose 3. Acute diabetes complications and treatment 4. Ramadan nutritional plan 5. Safe physical activity You will be taught to record <!-- --> 1. Meal plans 2. Physical activities 3. Blood glucose monitoring, and 4. Monitoring for diabetes complications Perform a trial fasting day prior to Ramadan. 2. Medication adjustments will be made according to the Diabetes and Ramadan Alliance guideline as well as individualized modifications based on their HbA1c as follows Baseline HbA1c Recommended dose reduction < 8% 30% 8 to 10% 15% > 10% None 2) Glucose monitoring 1. up to 4 times daily Before Ramadan for 1 week During Ramadan After Ramadan for 1 week 2. uploaded into an online portal for data collection, without remote monitoring. | Combination product | Focused structured tele-education, medication adjustment and remote monitoring |
Primary outcome
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan
Time frame: 4 weeks
5 secondary outcomes
Compare the first incidence rate of hypoglycemia or severe hypoglycemia between intervention and control groups in Ramadan when compared to 4 weeks before and 4 weeks post-Ramadan
Time frame: 12 weeks
Compare the first incidence rate of other complications in Ramadan - hyperglycemia and crises, acute infections, clinic and emergency department attendances and hospital admissions
Time frame: 12 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of blood glucose monitoring during Ramadan
Time frame: 4 weeks
Compare the compliance to current Ramadan treatment recommendations for diabetes based on number of days of fast terminated in the event of hypoglycaemia or hyperglycemia
Time frame: 12 weeks
Compare the weight changes after Ramadan as compared to pre-Ramadan weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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 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 diabetes tele-education and medication adjustment based on guidelines with remote monitoring from trial of fasting from before to throughout Ram 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baskar Rajamanickam (69304463, research@skh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare first incidence rate of hypoglycaemia or severe hypoglycemia between intervention and control groups in Ramadan (time frame: 4 weeks). 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 21 Sep 2023.