Safety of Closed-loop Hybrid Insulin Administration During Ramadan Fasting in People Living With Type 1 Diabetes

Completed

• Conditions: Type1diabetes

• Registration Number: NCT05747352
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Detailed Description

Primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (CGM) glycemic parameters during the Ramadan fasting period Primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (TIR) from 30 days prior to the Ramadan fasting period to 30 days during the fasting period

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Study Start: 2023-06-05
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose time	Day 30	time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period

Secondary Outcome Measures

Name	Time	Method
Glucose time	Day 60	time spent below target 2.97 mmol/l, between 2.97 and 3.79 mmol/l, between 9.05 mmol/l and 12.5mmol/l and \> 12.5 mmol/l

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France