Evaluation of the A1CNow+ Test Kit

The purpose of this study was to assure that consumers could successfully use the new
version of A1CNow+ Test Kit along with revised instructional materials. The primary
objective was to establish accuracy and secondary objectives were to establish precision,
comprehension of instructional materials, and user feedback about the overall testing
experience.

Inclusion Criteria:

1. Adults (age 18 and older) approximately 80% being ≤55 years old

2. Persons with:

- known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of
subject population per site

- no known diagnosis of diabetes - approximately 15% of subject population per
site

3. Individuals who are interested in performing a test using the kit at home

4. Individuals willing to complete all study procedures (including venous draw and
allowing site staff to perform finger punctures)

5. Individuals who are able to speak, read, and understand English

6. Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional
materials to demonstrate ability to read the print (may use glasses, if needed)

Exclusion Criteria:

1. Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have
clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not
excluded)

2. Individuals with known Rheumatoid Arthritis or other condition causing significant
impairment of manual dexterity

3. Individuals with a known hemoglobin variant such as HbS or HbC

4. Individuals with any known disorder of the blood or blood-forming organs (such as
recovery from blood loss, hemolytic anemia, or iron deficiency anemia)

5. Individuals who have received a blood transfusion within the 4 months prior to the
study.

6. Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)

7. Individuals working for a competitive medical device company

8. Individuals who have participated in previous studies on the A1CNow+ product

9. Persons missing a digit or partial digits on the hand

10. Individuals with the following impairments which, in the opinion of the investigator,
would seriously compromise the integrity of the study:

- Significant visual impairment

- Significant hearing impairment

- Cognitive disorder

- Any other condition as per investigator's discretion