Health Education During Ramadan Fasting in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501511
• Other study ID #: FMASU/MS 20/2017
• Status: Completed
• Phase: N/A
• Start date: April 7, 2018
• Est. completion date: June 28, 2018

Study information

• Verified date: June 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fasting

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Egypt	Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia	Rate of attacks of hypoglycemia during Ramadan	Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Secondary	Insulin Dose Adjustment	percent reduction or increase in basal and bolus insulin dose during month of Ramadan	During 4 weeks of Ramadan fasting
Secondary	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
Secondary	Number of successful fasting days	Number of days completed fasting per patient	During 4 weeks of Ramadan fasting