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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06977633
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes for at least 1 year without significant endogenous insulin production
* Currently using insulin pump
* Understanding and willingness to follow the protocol and sign informed consent.
* Willingness to sign a consent for release of medical information at the time of enrollment
* Ability to speak, read and write in the language of the investigators.
Exclusion Criteria:
* History of DKA or severe hypoglycemia within the past 6 months
* eGFR \<45 mL/min/1.73 m2 or other significant renal impairment
* Pregnancy or breastfeeding
* Current use of non-insulin medications affecting ketone production, including SGLT2 inhibitors
* Active skin infections or conditions affecting sensor application sites
* Known skin allergies to tapes or adhesives
* Current use of any long-acting insulin analogs
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06977633
Study Brief:
Protocol Section:
NCT06977633