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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT03607435
Eligibility Criteria:
Inclusion Criteria:
Ideally, all enrolled participants will represent an ethnically diverse population with as close to an even ratio of males to females as possible.
1\) Age ≥ 21 years. 2) Willingness and ability to provide informed consent.
* Additional inclusion criteria specific to KBS-1 (Test Article #01) testing:
1\) Diabetic hospital staff
* Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
1. Hospital patients with a physician prescribed hospital laboratory blood test.
2. Diabetic hospital staff
Exclusion Criteria:
The following exclusion criteria apply to all prospective study participants.
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1. A member of a vulnerable population (i.e. children, pregnant women, prisoners, etc.)
2. People with clotting factor disorders and/or currently taking anticoagulation medication.
3. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee).
* Additional exclusion criteria specific to KBS-1 (Test Article #01) testing:
1. Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded.
2. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.
* Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
1. Patient is in isolation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03607435
Study Brief:
Protocol Section:
NCT03607435