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Health Education During Ramadan Fasting in Type 1 Diabetes

Not Applicable
Completed
Conditions
Fasting
Diabetes Mellitus, Type 1
Interventions
Behavioral: Conversational Maps
Behavioral: IDF modules
Registration Number
NCT03501511
Lead Sponsor
Ain Shams University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
53
Inclusion Criteria
  1. Patients are intending to fast .
  2. Duration of diabetes is more than 5 years .
  3. Insulin regimen is basal-bolus .
Read More
Exclusion Criteria
  1. Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
  2. Pregnancy .
  3. Previous stroke, MI, or unstable angina .
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conversational MapsConversational MapsDiabetes Educations using Ramadan fasting conversational maps (Arabic maps)
IDF modulesIDF modulesDiabetes educations using IDF Arabic translated modules
Primary Outcome Measures
NameTimeMethod
HypoglycemiaDetected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting

Rate of attacks of hypoglycemia during Ramadan

Secondary Outcome Measures
NameTimeMethod
Insulin Dose AdjustmentDuring 4 weeks of Ramadan fasting

percent reduction or increase in basal and bolus insulin dose during month of Ramadan

Number of successful fasting daysDuring 4 weeks of Ramadan fasting

Number of days completed fasting per patient

Body Weight ChangeMeasurement of body weight prior month of Ramadan and after the month of Ramadan

Increase or decrease of body weight at the end of Ramadan month fasting

Trial Locations

Locations (1)

Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit

🇪🇬

Cairo, Egypt

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