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PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days

NCT03808376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2024-08-20

Study results available
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Summary

The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use.

The investigation will also evaluate safety of the Eversense® 180 CGM System usage.

Conditions

Interventions

DEVICE

Continuous Glucose Monitoring System

The Eversense® 180 CGM System

Sponsors & Collaborators

  • Senseonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Satish Garg, MD · Barbara Davis Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2020-05-08
Completion
2020-05-08
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03808376 on ClinicalTrials.gov