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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05747352

Acronym

RAMDAM

Enrollment

Registered

2023-02-28

Start date

2023-06-05

Completion date

2023-09-13

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes

Keywords

type1diabetes, the Ramadan fasting period, closed-loop hybrid insulin administration

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

Interventions

OTHERclosed-loop hybrid insulin administration

observational non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026