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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501511
Enrollment
53
Registered
2018-04-18
Start date
2018-04-07
Completion date
2018-06-28
Last updated
2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Fasting

Keywords

Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia

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.

Interventions

BEHAVIORALIDF modules

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

BEHAVIORALConversational Maps

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
HypoglycemiaDetected through Self monitoring of blood glucose during 4 weeks of Ramadan fastingRate of attacks of hypoglycemia during Ramadan

Secondary

MeasureTime frameDescription
Insulin Dose AdjustmentDuring 4 weeks of Ramadan fastingpercent reduction or increase in basal and bolus insulin dose during month of Ramadan
Body Weight ChangeMeasurement of body weight prior month of Ramadan and after the month of RamadanIncrease or decrease of body weight at the end of Ramadan month fasting
Number of successful fasting daysDuring 4 weeks of Ramadan fastingNumber of days completed fasting per patient

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026