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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT04838392
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be 18 years and older
* Subjects must have a diagnosis of type 1 or type 2 diabetes mellitus
* Subjects must be available to participate in all clinical sessions with the following parameters:
* Subject must be willing to wear 1 sensor on each upper arm simultaneously.
* Subjects must be willing to have their glucose levels manipulated in each in-clinic visit.
* Subjects must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Subjects must be willing and able to provide signed written consent.
* Subjects must be able to speak, read and write English.
Exclusion Criteria:
* Known allergy and not able to tolerate to medical grade tape adhesive.
* Presence and unresolved of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Subjects who have or are female of child-bearing potential age:
* Has a positive pregnancy screening test
* That plans to become pregnant during the course of study.
* Diagnosed with hemophilia or any other bleeding disorders
* Acute or chronic kidney disease
* Currently managed by dialysis or anticipating initiating dialysis during the course of study.
* Current or know history of coronary artery or cardiovascular disease that is not stable with medical management thromboembolic disease.
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose excessive risk to study staff.
* Prior to enrollment, subject has had:
* Severe hypoglycemia within past 6 months.
* History of Diabetic Ketoacidosis (DKA) within the past 6 months,
* History of a seizure disorder within the last 6 month
* Hypoglycemia unawareness.
* Severe diabetes related complications.
* Required or scheduled to have a Magnetic Resonance Imagining (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period.
* Plans to donate blood during the course of the study
* Insulin-dependent type 2 subjects that receive sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor) treatment\[14\]
* Hematocrit (Hct) level lower than the normal reference range
* Weight less than 110 pounds (50 kg)
* Participated in another clinical trial within 2 weeks prior to screening
* Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04838392
Study Brief:
Protocol Section:
NCT04838392