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PROFESSIONAL INSERTION HELPS REDUCE MEMBER ERROR AND RISK
 

PROFESSIONAL INSERTION HELPS REDUCE MEMBER ERROR AND RISK

 
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Eversense’s unique fully inserted

Eversense’s unique subcutaneous sensor is designed to be inserted and removed by a health care professional in a sterile clinical setting. This can reduce the risk of injuries, site infections and other adverse events associated with patient self-insertions and removals in the home.

In two pivotal studies (PRECISE ll and PRECISION), the Eversense CGM demonstrated an excellent safety profile, as measured by the low incidence of adverse events tied to the device or sensor insertion/removal procedures, during continuous use for up to 90 days.1,2

 

“The study had demonstrated the safety of an implanted CGM system in a controlled multicenter clinical trial and did not expose any unanticipated risks.”²

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NO DEVICE-RELATED SAE ACROSS TWO MAJOR STUDIES

NO DEVICE-RELATED SAE ACROSS MAJOR STUDIES1,2

Serious adverse event (SAE) findings | Precise II

SAE BY
RELATIONSHIP TO STUDY
NUMBER OF
SAES
All SAEs 1
Device related
SAEs
0
Sensor
procedure
related SAEs
1
Study
procedure
related SAEs
0
Unrelated to
study SAEs
0
SAE by
relationship to study
Subject with
SAEs (%)
All SAEs 1 (1.1%)
Device related
SAEs
0 (0.0%)
Sensor
procedure
related SAEs
1 (1.1%)
Study
procedure
related SAEs
0 (0.0%)
Unrelated to
study SAEs
0 (0.0%)
SAE by
relationship to study
95%
Confidence
interval
All SAEs 0.0% - 6.0%
Device related
SAEs
0.0% - 4.0%
Sensor
procedure
related SAEs
0.0% - 6.0%
Study
procedure
related SAEs
0.0% - 4.0%
Unrelated to
study SAEs
0.0% - 4.0%

Ninety (90) study subjects were implanted with the sensor in their upper arm. A subset of fifteen (15) subjects had two (2) sensors inserted bilaterally.

 

Source | Precise II Pivotal trial of a long term implantable CGM system: 90 days of sustained accuracy and strong safety profile. 2017

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To learn more on how a professionally

To learn more on how a professionally-inserted CGM system can reduce risk to members, download the Eversense Safety Profile Info Sheet.

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List
  1. PRECISE II Pivotal Trial of A Long Term Implantable CGM System: 90 Days of Sustained Accuracy and Strong Safety Profile. 2017.
  2. Christiansen MP, The PRECISION Study. Diabetes Technology & Therapeutics. 2019;21(5):231-237.
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