Health Education During Ramadan Fasting in Type 1 Diabetes
NCT ID: NCT03501511
Last Updated: 2018-06-29
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
53 participants
INTERVENTIONAL
2018-04-07
2018-06-28
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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IDF modules
Diabetes educations using IDF Arabic translated modules
IDF modules
Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting
Conversational Maps
Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)
Conversational Maps
Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting
Interventions
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IDF modules
Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting
Conversational Maps
Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting
Eligibility Criteria
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Inclusion Criteria
2. Duration of diabetes is more than 5 years .
3. Insulin regimen is basal-bolus .
Exclusion Criteria
2. Pregnancy .
3. Previous stroke, MI, or unstable angina .
16 Years
35 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Dr.Yara Eid
Professor of Internal Medicine-Endocrinology and Metabolism Unit , Ain-Shams University
Principal Investigators
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Yara M Eid, MD
Role: PRINCIPAL_INVESTIGATOR
Ain-Shams University -Faculty of Medicine
Manal A AbuShady, MD
Role: STUDY_CHAIR
Ain-Shams University -Faculty of Medicine
Mona M AbdelSalam, MD
Role: STUDY_DIRECTOR
Ain-Shams University -Faculty of Medicine
Locations
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Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU/MS 20/2017
Identifier Type: -
Identifier Source: org_study_id