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

Type1diabetes Clinical Trial

— RAMDAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747352
• Other study ID #: 2023/0003
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

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