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PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm

NCT03251079 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-02-12

Study results available
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Summary

The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI) glucose analyzer reference standard measurements using a next generation transmitter and algorithm. Other measures evaluated will be the effects of compression on performance and the safety of the Senseonics CGM system.

Conditions

Interventions

DEVICE

Continuous glucose monitoring system

Implanted continuous glucose monitoring system

Sponsors & Collaborators

  • Senseonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Christiansen, MD · Diablo Clinical Research

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-02-01
Completion
2018-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251079 on ClinicalTrials.gov