CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 208 enrolled
Drug / intervention
Continuous Glucose Monitoring Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03808376
NCT03808376N/ACompleted
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PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days

Senseonics, Inc.·interventional·Posted Jan 17, 2019·Updated Aug 20, 2024

In Brief

A clinical study evaluating Continuous Glucose Monitoring System for Diabetes Mellitus and 2 related conditions. Completed, enrolled 208 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 17, 2019
Enrollment StartDec 27, 2018
Primary CompletionMay 8, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.5 years ago

Interventions

Continuous Glucose Monitoring Systemdevice

The Eversense® 180 CGM System