Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05560568
Eligibility Criteria:
Inclusion Criteria:
* Patients usually followed by the Diab-eCare service (HCL), male or female, between 18 and 50 years old,
* Confirmed diagnosis of type 1 diabetes for more than 1 year regardless of age of diagnosis,
* Eligible according to current recommendations and the center's practices for a hybrid closed-loop solution including all Dexcom G6,
* On pump, whatever the device used, for at least 6 months and with a Dexcom G6 CGM sensor for at least one month with more than 95% of data obtained,
* BMI\<30 kg/m2,
* HbA1C \<10%,
* Do not oppose to the said research.
Exclusion Criteria:
* Patients with type 2 diabetes,
* Patients with a cause other than diabetes that could disrupt sleep:
* Known or suspected sleep apnea syndrome with high risk according to the Berlin questionnaire, And/or
* Presence of risk factors such as severe retinopathy, nephropathy, hypertension, autonomic neuropathy, chronic psychiatric disorders, endocrine or metabolic pathologies that have not been stabilized, therapeutics that may alter sleep (i.e. sleeping pills, corticosteroids, antidepressants, anxiolytics, antihistamines), regular use of cannabis, abusive use of alcohol (regularly \> 3 drinks per day for a man and \> 2 drinks for a woman) And/or
* Night or shift work,
* Inability to collect data and/or understand the objectives of the study according to the investigator,
* Persons under legal protection,
* Persons not affiliated with a social security system
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05560568
Study Brief:
Protocol Section:
NCT05560568