Status:
UNKNOWN
A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?
Lead Sponsor:
Dasman Diabetes Institute
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21+ years
Brief Summary
Fasting Ramadan is one of the five pillars of Islam and requested only from healthy adults to abstain from eating and drinking from sunrise to sunset. People with type 1 diabetes mellitus (TIDM) are e...
Detailed Description
INTRODUCTION/BACKGROUND Diabetes and Ramadan (DAR) and IDF international collaboration created the IDF-DAR guidelines which include the practical recommendations for HCP to better manage people with ...
Eligibility Criteria
Inclusion
- T1DM for 12 months or more
- Age \>21 years old
- Current user of FSL and plan to use it during Ramadan
- HbA1C \<10%
- Planning to fast Ramadan
- People with T1DM on insulin pump
Exclusion
- Any significant diabetes-related complications including, but not limited to
- Any recent episode of severe hypoglycemia in the preceding 12 months
- Any recent DKA in the preceding 12 months
- Diabetic nephropathy with eGFR \<60ml/minute/1.73m2
- Diabetic retinopathy ≥R2, ≥M1
- Peripheral neuropathy
- Active or recent foot ulcers
- HbA1c greater than 10%.
- Hypoglycaemia unawareness
- Pregnancy or plannig for pregnancy over the duration of the study
- Breast feeding
- Active malignancy
- Uncontrolled thyroid disorders
- Not able to attend study visits
- Not able or not willing to give written informed consent
- Not DAFNE graduates
Key Trial Info
Start Date :
April 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 17 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04135248
Start Date
April 18 2019
End Date
April 17 2020
Last Update
October 22 2019
Active Locations (1)
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1
Dasman Diabetes Institute
Kuwait City, Dasman, Kuwait, 15462