Diabetes Mellitus, Type 1NCT03501511
Health Education During Ramadan Fasting in Type 1 Diabetes
A study testing IDF modules and Conversational Maps in people with Diabetes Mellitus, Type 1 and Fasting, run by Ain Shams University at 1 site in Egypt.
Trial summary
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Fasting
- What is being tested?
- IDF modules and Conversational Maps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2018to 28 Jun 2018
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients are intending to fast .
- Duration of diabetes is more than 5 years .
- Insulin regimen is basal-bolus .
Who cannot join
- Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
- Pregnancy .
- Previous stroke, MI, or unstable angina .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit
Cairo, 11591
About this study
Official title: Comparison of Two Health Education Modalities for Safe Ramadan Fasting in People With Type 1 Diabetes
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season.
People with type 1 Diabetes are among those who are risky to fast this holy month in the Muslim faith and thus are exempted from fasting. Yet many patients fast in spite of medical advice and religious exemption and for those patients, healthcare professionals should provide the utmost care and continuous diabetes education.
Read more
Different diabetes education modalities exist like DSME (Diabetes self-management education with proven efficacy. One modality is the Diabetes Conversation Map which delivers diabetes education interactively through a series of maps that address different issues in diabetes management and includes a specially designed Ramadan map.
In this study, two modalities of Diabetes focused Ramadan education will be compared regarding aiding patients to fast Ramadan safely. One modality will be Diabetes conversation maps and the other the International Diabetes Federation Education modules.
Read the detailed description
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season. Although exempt, many diabetics refuse to take this concession as they feel psychologically \& spiritually inclined to fast along with other Muslims.
Fasting at Ramadan carries a very high risk for people with T1DM. This risk is particularly exacerbated in poorly controlled patients and those with limited access to medical care, hypoglycemic unawareness, unstable glycemic control, or recurrent hospitalizations.
Structured education interventions have been endorsed by the National Institute for Health and Clinical Excellence as important in empowering patients to improve their jour¬ney with diabetes. In a large observational study, patients who fasted during Ramadan without attending a structured education session had a fourfold increase in hypoglycae¬mic events, whereas those who attended an education pro¬gramme focusing on Ramadan had a significant decrease in hypoglycemic events.
Conversation Map aims to help people with diabetes experience a healthier Ramadan. The interactive Map covers a number of topics including understanding the risks and complications of fasting and the importance of creating a diabetes management plan during this time.
- Conditions
- Diabetes Mellitus, Type 1, Fasting
- Being tested
- IDF modules, Conversational Maps
- Keywords
- Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDF modulesBehavioural
Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting
Conversational MapsBehavioural
Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting
| Study group | Role | What they receive |
|---|---|---|
| IDF modules | Active comparator | Diabetes educations using IDF Arabic translated modules Receives: Behavioral: IDF modules |
| Conversational Maps | Experimental | Diabetes Educations using Ramadan fasting conversational maps (Arabic maps) Receives: Behavioral: Conversational Maps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Rate of attacks of hypoglycemia during Ramadan
Measured: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Secondary outcomes (3)
Insulin Dose Adjustment
percent reduction or increase in basal and bolus insulin dose during month of Ramadan
Measured: During 4 weeks of Ramadan fasting
Body Weight Change
Increase or decrease of body weight at the end of Ramadan month fasting
Measured: Measurement of body weight prior month of Ramadan and after the month of Ramadan
Number of successful fasting days
Number of days completed fasting per patient
Measured: During 4 weeks of Ramadan fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start7 Apr 2018
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Yara Eid, Ain Shams University
- Investigators
- Yara M Eid, MD, Principal investigator, Ain-Shams University -Faculty of MedicineManal A AbuShady, MD, Study chair, Ain-Shams University -Faculty of MedicineMona M AbdelSalam, MD, Study director, Ain-Shams University -Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501511
- Sponsor's protocol ID
- FMASU/MS 20/2017
- Status last verified
- Jun 2018
- First submitted
- 10 Apr 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Health Education Modalities for Safe Ramadan Fasting in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03501511
- Acronym / sponsor ID
- FMASU/MS 20/2017
- Conditions
- Diabetes Mellitus, Type 1, Fasting
- Keywords
- Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Apr 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 18 Apr 2018 (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.
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season.
People with type 1 Diabetes are among those who are risky to fast this holy month in the Muslim faith and thus are exempted from fasting. Yet many patients fast in spite of medical advice and religious exemption and for those patients, healthcare professionals should provide the utmost care and continuous diabetes education.
Different diabetes education modalities exist like DSME (Diabetes self-management education with proven efficacy. One modality is the Diabetes Conversation Map which delivers diabetes education interactively through a series of maps that address different issues in diabetes management and includes a specially designed Ramadan map.
In this study, two modalities of Diabetes focused Ramadan education will be compared regarding aiding patients to fast Ramadan safely. One modality will be Diabetes conversation maps and the other the International Diabetes Federation Education modules.
Detailed description
Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season. Although exempt, many diabetics refuse to take this concession as they feel psychologically \& spiritually inclined to fast along with other Muslims.
Fasting at Ramadan carries a very high risk for people with T1DM. This risk is particularly exacerbated in poorly controlled patients and those with limited access to medical care, hypoglycemic unawareness, unstable glycemic control, or recurrent hospitalizations.
Structured education interventions have been endorsed by the National Institute for Health and Clinical Excellence as important in empowering patients to improve their jour¬ney with diabetes. In a large observational study, patients who fasted during Ramadan without attending a structured education session had a fourfold increase in hypoglycae¬mic events, whereas those who attended an education pro¬gramme focusing on Ramadan had a significant decrease in hypoglycemic events.
Conversation Map aims to help people with diabetes experience a healthier Ramadan. The interactive Map covers a number of topics including understanding the risks and complications of fasting and the importance of creating a diabetes management plan during this time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDF modules | Active comparator | Behavioral: IDF modulesDiabetes educations using IDF Arabic translated modules |
| Conversational Maps | Experimental | Behavioral: Conversational MapsDiabetes Educations using Ramadan fasting conversational maps (Arabic maps) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients are intending to fast .
- Duration of diabetes is more than 5 years .
- Insulin regimen is basal-bolus .
Key exclusion criteria (3 listed)
- Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
- Pregnancy .
- Previous stroke, MI, or unstable angina .
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 |
|---|---|---|
| IDF modulesPatients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting | Behavioural | IDF modules |
| Conversational MapsPatients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting | Behavioural | Conversational Maps |
Primary outcome
Hypoglycemia
Time frame: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Rate of attacks of hypoglycemia during Ramadan
3 secondary outcomes
Insulin Dose Adjustment
Time frame: During 4 weeks of Ramadan fasting
Body Weight Change
Time frame: Measurement of body weight prior month of Ramadan and after the month of Ramadan
Number of successful fasting days
Time frame: During 4 weeks of Ramadan fasting
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 29 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yara M Eid, MD principal investigator
Ain-Shams University -Faculty of Medicine
Manal A AbuShady, MD study chair
Ain-Shams University -Faculty of Medicine
Mona M AbdelSalam, MD study director
Ain-Shams University -Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDF modules and Conversational Maps in people with Diabetes Mellitus, Type 1 and Fasting, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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 29 Jun 2018. 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 Egypt. 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?
Hypoglycemia (time frame: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting). 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 29 Jun 2018.