Health Education During Ramadan Fasting in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Health Education Modalities for Safe Ramadan Fasting in People With Type 1 Diabetes

Conditions
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Fasting, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: IDF modules
* Behavioral: Conversational Maps


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are intending to fast . Duration of diabetes is more than 5 years . Insulin regimen is basal-bolus . Exclusion Criteria: Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan . Pregnancy . Previous stroke, MI, or unstable angina .

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IDF modules<br>Diabetes educations using IDF Arabic translated modules | Behavioral: IDF modules<br>* Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting<br>|
| Experimental: Conversational Maps<br>Diabetes Educations using Ramadan fasting conversational maps (Arabic maps) | Behavioral: Conversational Maps<br>* Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Rate of attacks of hypoglycemia during Ramadan | Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Dose Adjustment | percent reduction or increase in basal and bolus insulin dose during month of Ramadan | During 4 weeks of Ramadan fasting | 
| Body Weight Change | Increase or decrease of body weight at the end of Ramadan month fasting | 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 | During 4 weeks of Ramadan fasting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia