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 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