Health Education During Ramadan Fasting in Type 1 Diabetes

Ain Shams University

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Fasting

Treatments: Behavioral: IDF modules; Behavioral: Conversational Maps

Study type: Interventional

Funder types: Other

Identifiers

NCT03501511

FMASU/MS 20/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients are intending to fast .
2. Duration of diabetes is more than 5 years .
3. Insulin regimen is basal-bolus .

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 .

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

IDF modules

Active Comparator group

Description:

Diabetes educations using IDF Arabic translated modules

Treatment:

Behavioral: IDF modules

Conversational Maps

Experimental group

Description:

Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)

Treatment:

Behavioral: Conversational Maps