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

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Glycemic Profile During the Ramadan Fasting in People With Type 1 Diabetes Treated With Closed-loop Hybrid Insulin System

Conditions
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Type1diabetes

Intervention / Treatment
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* Other: closed-loop hybrid insulin administration


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: closed-loop hybrid insulin administration|observational non-interventional study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose time | time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose time | The time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in 30 days prior the Ramadan period | Day 60 | 
| Glucose time | time spent below target 3.9 mmol/l | Day 30 | 
| Glucose time | 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 | Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type1diabetes, the Ramadan fasting period, closed-loop hybrid insulin administration