Senseonics Announces Results of the PROMISE Study Demonstrating Strong Accuracy of 180 Day CGM Sensor
03 Junho 2021 - 5:05PM
Business Wire
-Overall MARD of 8.5%-9.1% during 180 Day Period
Senseonics Holdings, Inc. (NYSE-American: SENS), a medical
technology company focused on the development and commercialization
of the first and only long-term, implantable continuous glucose
monitoring (CGM) system – the Eversense® CGM System – today
announced the results of the PROMISE Study evaluating the accuracy
and safety of the next generation Eversense CGM System for up to
180 days with reduced calibrations. The data was presented by
Satish Garg, MD, Professor of Medicine at the Barbara Davis Center
of the University of Colorado, Denver, and the study group
Principal Investigator (PI), as an oral presentation at the 14th
Annual ATTD Meeting. Results were presented for both the primary
sensor and for a secondary sensor with modified chemistry (referred
to as the SBA sensor) in a subset of study participants.
“The value of CGM for patients with diabetes, especially those
requiring insulin, is unquestioned,” said study PI, Dr. Satish
Garg. “To enable more patients to utilize CGM, there needs to be
choice in product features. The accuracy profile demonstrated by
Eversense in the PROMISE Study validates the role that long-term
implantable CGM systems can play in helping people manage their
glucose levels.”
Study results:
- Overall mean absolute relative difference (MARD) against
reference value was 9.1% for the primary sensor over 49,000 paired
points and 8.5% for the SBA sensor over 12,000 paired points.
- The percent sensor readings within 20 mg/dL or 20% of reference
values (20/20% agreement rate) were as follows:
- Across the full 40-400 mg/dL range, the agreement rate was
92.9% for the primary sensor and 93.9% for the SBA sensor.
- In the hypoglycemic ranges of 40-60 mg/dL and 61-80 mg/dL, the
agreement rates were 89.4% and 92.2% for the primary sensor and
96.5% and 96.8% for the SBA sensor, respectively.
- Confirmed hypoglycemic alert detection rate was 93% for primary
sensor and 94% for the SBA sensor.
- There were no related serious adverse events, all sensors were
removed during the initial removal procedure and 1.1% of patients
had a mild infection at the procedure site.
“We are very pleased with the results of the PROMISE Study which
demonstrate an excellent safety and accuracy profile for the
180-day sensor. This study was initiated December 2018 and we’re
very grateful to the tireless Clinical Investigators and the
devoted study subjects for participating in this important clinical
trial,” said Tim Goodnow, PhD, President and CEO of Senseonics. “As
we await hearing from the US and European regulatory agencies
concerning our pre-market submissions of data from both the primary
and the SBA sensors, we are pleased to continue to offer the
Eversense CGM systems in both the US and Europe with our
commercialization partner, Ascensia Diabetes Care.”
The PROMISE Study was a prospective, multicenter trial designed
to evaluate the Eversense CGM System in people with diabetes over a
180-day period and was the basis of the pre-market application
submissions to the U.S. Food and Drug Administration and to BSI for
CE mark in Europe. One hundred and eighty-one (181) study
participants at eight sites across the United States had a primary
sensor inserted subcutaneously in their left upper arm; 43 of these
participants also had an SBA sensor inserted in their right arm.
Participants underwent 10 clinic visits between days 1-180 to
measure accuracy by comparing the sensor glucose values with the
standard reference YSI glucose values obtained simultaneously.
Subjects also underwent hypoglycemia and hyperglycemia challenges
to assess performance over the glucose range of 40-400 mg/dL, the
reporting range of the device. Data from both the primary and the
SBA sensors were subsequently included in the pre-market
submissions.
The Eversense CGM System consists of a fluorescence-based
sensor, a smart transmitter worn over the sensor to facilitate data
communication, and a mobile app for displaying glucose values,
trends and alerts. In addition to featuring the first long-term and
first implantable CGM sensor, the system is also first to feature a
smart transmitter that provides wearers with discreet on-body
vibratory alerts for high and low glucose and can be removed,
recharged and re-attached to the skin without discarding the
sensor. Eversense users are able to make treatment decisions based
on their Eversense readings in the US. The sensor is inserted
subcutaneously in the upper arm by a health care provider via a
brief in-office procedure.
About Eversense
The Eversense® Continuous Glucose Monitoring (CGM) System is
indicated for continually measuring glucose levels in persons age
18 and older with diabetes for up to 90 days in the US and 180 days
in Europe. The system is indicated for use to replace fingerstick
blood glucose (BG) measurements for diabetes treatment decisions in
the US. Fingerstick BG measurements are still required for
calibration twice per day, and when symptoms do not match CGM
information or when taking medications of the tetracycline class.
The sensor insertion and removal procedures are performed by a
healthcare provider. The Eversense CGM System is a prescription
device; patients should talk to their health care provider to learn
more. For important safety information, see
https://eversensediabetes.com/safety-info/.
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the design, development and commercialization of
transformational glucose monitoring products designed to help
people with diabetes confidently live their lives with ease.
Senseonics' CGM Systems, Eversense® and Eversense® XL, include a
small sensor inserted completely under the skin that communicates
with a smart transmitter worn over the sensor. The glucose data are
automatically sent every 5 minutes to a mobile app on the user's
smartphone.
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Senseonics Investor Contact Lynn Lewis or Philip Taylor
Investor Relations 415-937-5406 investors@senseonics.com
Senseonics Media Contact: Mirasol Panlilio
301-556-1631
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