NCT03501511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

April 10, 2018

Last Update Submit

June 28, 2018

Conditions

Diabetes Mellitus, Type 1Fasting

Keywords

Diabetes MellitusType1;Fasting;Health Education;Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia

    Rate of attacks of hypoglycemia during Ramadan

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

Secondary Outcomes (3)

  • Insulin Dose Adjustment

    During 4 weeks of Ramadan fasting

  • Body Weight Change

    Measurement of body weight prior month of Ramadan and after the month of Ramadan

  • Number of successful fasting days

    During 4 weeks of Ramadan fasting

Study Arms (2)

IDF modules

ACTIVE COMPARATOR

Diabetes educations using IDF Arabic translated modules

Behavioral: IDF modules

Conversational Maps

EXPERIMENTAL

Diabetes Educations using Ramadan fasting conversational maps (Arabic maps)

Behavioral: Conversational Maps

Interventions

IDF modulesBEHAVIORAL

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

IDF modules
Conversational MapsBEHAVIORAL

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

Conversational Maps

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Fasting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesFeeding BehaviorBehavior

Study Officials

  • Yara M Eid, MD

    Ain-Shams University -Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Manal A AbuShady, MD

    Ain-Shams University -Faculty of Medicine

    STUDY CHAIR

  • Mona M AbdelSalam, MD

    Ain-Shams University -Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine-Endocrinology and Metabolism Unit , Ain-Shams University

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

April 7, 2018

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Locations

EG(1)