Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

In order to confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term
(preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes, subjects
with Type 1 or Type 2 diabetes will be enrolled whose HbA1c values range from 7.5% to 12%
(or higher) in Group 1 and <7.5% in Group 2 at Visit 1, and the comparison of glycated
albumin (GA) and other glycemic control indices will be performed during 6 months in 8
clinical sites in US. Group 1 will consist of 90 evaluable subjects who have a change in
diabetes management to improve glycemic control; this therapy can include oral agents,
insulin, or noninsulin injectable anti-diabetic medications. Group 2 will consist of 40
evaluable subjects already on a stable diabetic management program, who have had no change
in treatment in the last 3 months and for whom there is no plan to make a change during the
study period.

Inclusion Criteria:

Subjects may be included in the study if they meet all the following criteria:

1. Male and female subjects 18 years of age and older

2. Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1,
respectively)

3. Subjects with an HbA1c value within the range of 7.5% to 12% (or higher) for Group 1
and <7.5% for Group 2

Note: The study investigator or primary physician must be planning to institute, or
must be in the process of instituting, therapy to improve glycemic control for
subjects in Group 1; this therapy can include oral agents, insulin, or non-insulin
injectable anti-diabetic medications.

4. Willingness to complete the protocol requirements, including the use of SMBG and
attendance at all scheduled study visits; if selected for CGM monitoring, a
willingness to follow the additional requirements and to use only the CGM device
model provided for the study

5. Satisfactory completion of home SMBG measurements during the screening period of the
study prior to enrollment at Visit 2

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Any clinically significant disease, as determined by the investigator, that would
interfere with study evaluations including but not limited to the following current
or historical conditions/procedures (self-reported by the subject):

1. End-stage renal disease

2. Chronic kidney disease of Stage 3 or greater

3. Liver cirrhosis

4. Uncontrolled or untreated thyroid disease

5. Any other acute or chronic conditions that, in the opinion of the investigator,
may significantly influence albumin or glucose metabolism (Note: routine iron
deficiencies and abnormal hemoglobin variants are not exclusions)

2. History within the last 6 months of a blood transfusion

3. Any other condition or factor that, in the opinion of the investigator, would
complicate or compromise the study or the well-being of the subject