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NCT05747352
Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes
Conditions: Type1diabetes
Sex: All
Ages: 18 Years – N/A
Enrollment: 70
Sponsor: Centre Hospitalier Sud Francilien
Location: France
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.
Eligibility Criteria
Inclusion Criteria:age > 18 yearstype 1 diabetes for > 1 yearon using closed-loop hybrid insulin administrationscheduled Ramadan fastingpatient put on using closed-loop hybrid insulin administration more than 2 months before the start of the Ramadan fastpercentage of continuous glucose monitoring sensor wear > 70% in at least one of the two 30-day periodsExclusion Criteria:patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the Ramadan fastpatient who is pregnant or wants to become pregnant immediatelypatient informed of the study who objected to the collection of his/her data.
Source: ClinicalTrials.gov (NCT05747352). StuddyBuddy aggregates publicly available trial information.