Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

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