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:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT06035367
Eligibility Criteria:
Inclusion Criteria:
* patients with type I diabetes
* male and female patients aged 18 to 50 years
* wearing a FreeStyle Libre CGM and giving the access of collected data
* using insulin pump or insulin pen and giving the access of collected data
* willing to wear the investigational device continuously throughout the study (24h/24h)
* affiliated with French Social Security
* having signed the informed consent form
Exclusion Criteria:
* any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases of skin, change in skin color...)
* any serious disease that could interfere with the study
* body mass index (BMI) \> 30kg/m2
* scars or tattoos on the upper side of the wrist wearing the investigational device
* who may have an allergy to one of the material used in the device
* who have magnetic resonance imagery (MRI), computed tomography (CT) scan or high frequency electrical heat (diathermy) treatment during the study
* persons mentioned in articles L1121-5 to L1121-9 of the public health code (Pregnancy or Lactation ; Females with childbearing potential, defined as a premenopausal female and not using an effective form of birth control\*; Person deprived of liberty by judicial order ; Person under guardianship or curatorship ; Minors ; Adults who are incapable or unable to give their consent ; Cross-over situations)
* who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
* who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of language problem, poor mental development
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06035367
Study Brief:
Protocol Section:
NCT06035367