Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes
RAMDAM
Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System
1 other identifier
observational
23
1 country
1
Brief Summary
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedStudy Start
First participant enrolled
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedNovember 7, 2023
November 1, 2023
3 months
February 17, 2023
November 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose time
time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period
Day 30
Secondary Outcomes (3)
Glucose time
Day 60
Glucose time
Day 30
Glucose time
Day 60
Interventions
observational non-interventional study
Eligibility Criteria
People with type 1 Diabetes
You may qualify if:
- age \> 18 years
- type 1 diabetes for \> 1 year
- on using closed-loop hybrid insulin administration
- scheduled Ramadan fasting
- patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fast
- percentage of continuous glucose monitoring sensor wear \> 70% in at least one of the two 30-day periods
You may not qualify if:
- patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fast
- patient who is pregnant or wants to become pregnant immediately
- patient informed of the study who objected to the collection of his/her data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106, France
Related Publications (1)
Outenah C, Ly Sall K, Penfornis A, Amadou C, Dardari D. Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes. Diabetes Technol Ther. 2024 Nov;26(11):e881-e884. doi: 10.1089/dia.2024.0168. Epub 2024 Jul 17.
PMID: 38888435DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Dured DARDARI, MD
Centre Hospitalier Sud Francilien
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2023
First Posted
February 28, 2023
Study Start
June 5, 2023
Primary Completion
September 13, 2023
Study Completion
September 13, 2023
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share