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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05747352
Other study ID # 2023/0003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date September 13, 2023

Study information

Verified date November 2023
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 13, 2023
Est. primary completion date September 13, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
closed-loop hybrid insulin administration
observational non-interventional study

Locations

Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose time time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in the Ramadan period Day 30
Secondary 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
Secondary Glucose time time spent below target 3.9 mmol/l Day 30
Secondary 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
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