The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of < 4%.

The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.

Change in HbA1c from Baseline at 6-Month Intervals. Window for 6, 12, and 18-month intervals was ± 30 days. Window for 24-month interval was -30 days to anything greater than 24 months.

CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.

The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.

Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.

The number analyzed in the first 2 rows are the subsets of the overall insertions based on HCP experience.

Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.

The number analyzed in the first 2 rows are the subsets of the overall removals based on HCP experience.

The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

The residual dexamethasone (DXA) content in Sensors was analyzed after removal.