Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes

Comparison of Clinical Decisions and Outcomes Employing a Treat to Target Design for Subjects With Type 2 Diabetes Randomized to Either SMBG or CGM

The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM for clinical diabetes management decision-making.

This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes:

1. Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter.
2. Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).

Inclusion Criteria:

• Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM)
• Clinical diagnosis of type 2 diabetes
• HbA1c ≥7.0%
• Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin.

Exclusion Criteria:

• Treated with Thiazolidinediones (TZD)
• Administered prednisone or cortisone medications in the previous 30 days
• Currently pregnant or planning pregnancy during the study period
• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
• HbA1c <7.0%
• Unable to follow the study protocol
• Unable to speak, read and write in English