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:

• Male and female subjects 18 years of age and older
• Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1, respectively)
• 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.

• Willingness to complete the protocol requirements, including the use of self-monitoring of blood glucose (SMBG) and attendance at all scheduled study visits; if selected for continious glucose monitoring (CGM) , a willingness to follow the additional requirements and to use only the CGM device model provided for the study
• 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:

• 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):

• End-stage renal disease
• Chronic kidney disease of Stage 3 or greater
• Liver cirrhosis
• Uncontrolled or untreated thyroid disease
• 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)
• History within the last 6 months of a blood transfusion
• 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