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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT04879693
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and older
* Admitted to the hospital in a non-ICU bed or once transferred out of ICU
* Anticipate at least 48 hours of hospital stay
* On treatment for glucose control.
* Willingness to complete the study.
* Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on the back of the arm or one on each arm and one on the abdomen.
* Subject and/or caretaker are able to speak, read, and write English
Exclusion Criteria:
* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis)
* Currently in an intensive care unit (ICU) of the following type (does not apply to participants placed in an ICU bed due to space issues in the non-ICU areas)
* Known allergy to medical-grade adhesives
* Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)
* Women admitted to give birth or any other admission related to pregnancy
* Patients receiving Hydroxyurea
* Bleeding disorder
* Participants that are currently being treated for malignancies, cancer
* Participant that are hospitalized to receive an organ transplant
* Require a Magnetic Resonance Imaging (MRI) scan
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Current participation in another investigational study protocol (If a subject has recently completed participation in another drug study, the subject must have completed that study at least 7 days prior to being enrolled in this study.)
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT04879693
Study Brief:
Protocol Section:
NCT04879693