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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

NCT01941238

Type 1 Diabetes

COMPLETED

Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

NCT01624116

Diabetes, Type 2

COMPLETED NA

Effect of Fasting on Insulin-induced Hypoglycemia Counterregulation in Healthy Humans

NCT04392843

Hypoglycemia

COMPLETED NA

Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

NCT03970772

Fasting Hypoglycemia Diabetes Mellitus, Type 1

COMPLETED NA

Hybrid Method Between Low-ratio Premixed Insulin and Short Acting Insulin in Fasting Type 2 Diabetic Patients in Ramadan

NCT06528002

Continous Blood Glucose Monitoring Calculation of Body Mass Index Measurment of Blood Pressure

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type1diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

closed-loop hybrid insulin administration

observational non-interventional study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No