Clinical trial NCT03501511: Health Education During Ramadan Fasting in Type 1 Diabetes
Official title: Comparison of Two Health Education Modalities for Safe Ramadan Fasting in People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Fasting
Keywords: Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 53
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Hypoglycemia
timeFrame: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Secondary outcomes:
measure: Insulin Dose Adjustment
timeFrame: During 4 weeks of Ramadan fasting
measure: Body Weight Change
timeFrame: Measurement of body weight prior month of Ramadan and after the month of Ramadan
measure: Number of successful fasting days
timeFrame: During 4 weeks of Ramadan fasting
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit
Study officials:
affiliation: Ain-Shams University -Faculty of Medicine
name: Yara M Eid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain-Shams University -Faculty of Medicine
name: Manal A AbuShady, MD
role: STUDY_CHAIR
affiliation: Ain-Shams University -Faculty of Medicine
name: Mona M AbdelSalam, MD
role: STUDY_DIRECTOR
References: