Health Education During Ramadan Fasting in Type 1 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Fasting
• Intervention / Treatment: Behavioral: IDF modules; Behavioral: Conversational Maps

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Yara M Eid, MD, Ain-Shams University -Faculty of Medicine; Study Chair: Manal A AbuShady, MD, Ain-Shams University -Faculty of Medicine; Study Director: Mona M AbdelSalam, MD, Ain-Shams University -Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: FMASU/MS 20/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No