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Health Education During Ramadan Fasting in Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1, Fasting

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IDF modules
Conversational Maps
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IDF modules

Conversational Maps

Arm Description

Diabetes educations using IDF Arabic translated modules

Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)

Outcomes

Primary Outcome Measures

Hypoglycemia
Rate of attacks of hypoglycemia during Ramadan

Secondary Outcome Measures

Insulin Dose Adjustment
percent reduction or increase in basal and bolus insulin dose during month of Ramadan
Body Weight Change
Increase or decrease of body weight at the end of Ramadan month fasting
Number of successful fasting days
Number of days completed fasting per patient

Full Information

First Posted
April 10, 2018
Last Updated
June 28, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03501511
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Fasting
Keywords
Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDF modules
Arm Type
Active Comparator
Arm Description
Diabetes educations using IDF Arabic translated modules
Arm Title
Conversational Maps
Arm Type
Experimental
Arm Description
Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)
Intervention Type
Behavioral
Intervention Name(s)
IDF modules
Intervention Description
Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting
Intervention Type
Behavioral
Intervention Name(s)
Conversational Maps
Intervention Description
Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting
Primary Outcome Measure Information:
Title
Hypoglycemia
Description
Rate of attacks of hypoglycemia during Ramadan
Time Frame
Detected through Self monitoring of blood glucose during 4 weeks of Ramadan fasting
Secondary Outcome Measure Information:
Title
Insulin Dose Adjustment
Description
percent reduction or increase in basal and bolus insulin dose during month of Ramadan
Time Frame
During 4 weeks of Ramadan fasting
Title
Body Weight Change
Description
Increase or decrease of body weight at the end of Ramadan month fasting
Time Frame
Measurement of body weight prior month of Ramadan and after the month of Ramadan
Title
Number of successful fasting days
Description
Number of days completed fasting per patient
Time Frame
During 4 weeks of Ramadan fasting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yara M Eid, MD
Organizational Affiliation
Ain-Shams University -Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manal A AbuShady, MD
Organizational Affiliation
Ain-Shams University -Faculty of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona M AbdelSalam, MD
Organizational Affiliation
Ain-Shams University -Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ain-Shams University-Faculty of Medicine- Ain-Shams University Hospitals -Internal Medicine Department -Endocrinology and Metabolism Unit
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Health Education During Ramadan Fasting in Type 1 Diabetes

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