Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Inclusion Criteria:

• Ages 2 or older
• Diagnosis of Type 1 diabetes or Type 2 diabetes
• Willing to wear the required number of Systems for the total duration of study wear
• Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

• Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin

• Known allergy to medical-grade adhesives

• Pregnancy

• Hematocrit outside specification

• ≥ 18 years of age:

  • Male: 36.0%;
  • Female: 33.0%;

• 13-17 years of age: 35.0%;

• 7 years - 12 years of age: 32.0%;

• End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period

• Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period