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Completed

NCT Number: NCT03501511

Health Education During Ramadan Fasting in 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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Diabetes Mellitus Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
  • Pregnancy .
  • Previous stroke, MI, or unstable angina .

Treatment and study plan

IDF modules

Behavioral

Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting

Conversational Maps

Behavioral

Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting

Primary outcomes

  1. Hypoglycemia

    Time frame: Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting

    Rate of attacks of hypoglycemia during Ramadan

Secondary outcomes

  1. Insulin Dose Adjustment

    Time frame: During 4 weeks of Ramadan fasting

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

  2. Body Weight Change

    Time frame: Measurement 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

  3. Number of successful fasting days

    Time frame: During 4 weeks of Ramadan fasting

    Number of days completed fasting per patient

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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