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

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05747352

Collaborator

(none)

Enrollment

Location

1.9

Anticipated Duration (Months)

36.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type1diabetes	Other: closed-loop hybrid insulin administration

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 Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 21, 2023

Anticipated Primary Completion Date :

Apr 21, 2023

Anticipated Study Completion Date :

Apr 21, 2023

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Glucose time [Day 60]
The time spent in the 3.9-10.0 mmol/l glucose target (TIR)) in 30 days prior the Ramadan period
Glucose time [Day 30]
time spent below target 3.9 mmol/l
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.