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CLINICAL TRIALS

PROVEN PERFORMANCE ACROSS THREE PIVOTAL STUDIES

 

The two PRECISE trials investigated the system’s accuracy, longevity and safety, along with glycemic control data and self-reported quality of life. The PRECISION study captured additional data on safety and accuracy. Combined, the three studies supported the clinical efficacy of Eversense and its exceptional long-term accuracy and wear time.

THE PRECISE (EUROPEAN) TRIAL, COMPLETED 201548

 

Performed over 180 days at 7 clinical sites in Europe, it studied a group of 71 adults with Type 1 and Type 2 diabetes using the Eversense CGM System at home and in the clinic. CGM accuracy was assessed during 8 in-clinic visits. The primary safety outcome was device-related serious adverse events. This trial also included a psychosocial sub-study to explore key issues including impact of device on perceptions of diabetes self-management and diabetes control.49

HbA1c improved in the study group from 7.54% (59 mmol/mol) at baseline to 7.19% (55 mmol/mol) at end of study. Device use coincided with a significant reduction in HbA1c within a short period of time.

HbA1c IMPROVEMENT ACROSS SUBJECTS REGARDLESS OF BASELINE

Precise Chart

 

Participants used the CGM for >23 hours per day over the full study duration. No device- or procedure-related serious adverse events were reported with the insertion, use and removal of 147 glucose sensors in 71 participants.

The psychosocial study results also indicated high device acceptance, with 84% rating “I would want to be inserted with a sensor again,” 90% rating “Using the system helped minimize the burden of diabetes in my life,” and a score of 5 or higher (range 1–7) on the CGM Impact Scale. Participants reported improvements on all domains of the Diabetes Distress Scale, and the device was positively associated with psychosocial functioning and quality of life.50

 

To learn more about Eversense long-term CGM’s exceptional accuracy and clinical outcomes download the full PRECISE study.

 

 

THE PRECISE II (U.S.) TRIAL, COMPLETED 2016 51

 

The second study (PRECISE II), performed in the United States, investigated the efficacy and safety of the Eversense CGM System during 90 days of continuous sensor wear. A total of 90 adults with Type 1 or Type 2 diabetes at 8 clinical centers were enrolled. Accuracy and safety endpoints were similar to those in the previous PRECISE study. This study also included an exercise session and durations of sensor compression.

Overall MARD value was 8.5%* (95% confidence interval: 8.1-9.3%). 91% percent of sensors were functional through day 90. Accuracy was not impacted by exercise or sensor compression. No infections or adhesive skin reactions were reported, and one related serious adverse event (1.1%) occurred during removal of a sensor.

The Eversense System detected 90% of hypoglycemic excursions (3.9 mmol/L) and 98% of hyperglycemic excursions (10 mmol/L).

PRECISE II STUDY SUMMARY

 

Precise II

Another investigation into the fluorescent glucose indicating technology used in the Eversense CGM System showed it is not affected by the same interferents as systems using electrochemical reactions to measure glucose. The Eversense CGM System retained the ability to accurately measure glucose concentrations in the presence of acetaminophen and Vitamin C, providing a potential safety advantage to patients.

 

To learn more about Eversense long-term CGM’s exceptional accuracy and clinical outcomes download the full PRECISE II study.

 

THE PRECISION TRIAL, COMPLETED 201852

 

This trial was designed to provide additional data on the Eversense CGM System across three metrics:

  • System accuracy within the first 30 days after Sensor insertion
  • Plasma dexamethasone concentration profiles after Sensor insertion
  • Additional safety and accuracy data for use up to 90 days

A total of 35 adults with Type 1 and Type 2 diabetes were inserted and evaluated. Glucose data was gathered in clinic at days 1, 7, 14, 30, 60 and 90. Results support the targeted indication, demonstrating the accuracy and safety of the Eversense CGM System for its intended use.

PRECISION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PRECISION2

 

45 Kropff, J. PRECISE. Diabetes Care, 2017; 40(1), 63-68. 46 Christiansen MP. PRECISE II. Diabetes Technology & Therapeutics. 2018;20(3):197-206. 47 Christiansen MP. The PRECISION Study. Diabetes Technology & Therapeutics. 2019. 48 Kropff, J. PRECISE. Diabetes Care, 2017; 40(1), 63-68. 49 Barnard KD. J Diabetes Sci Technol. 2018;12(3):634-638 50 Kropff, J. PRECISE. Diabetes Care, 207; 40(1), 63-68. 51 Christiansen MP. PRECISE II. Diabetes Technology & Therapeutics. 2018;20(3):197-206. 52 Christiansen MP. The PRECISION Study. Diabetes Technology & Therapeutics. 2019.

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