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Study of an Interstitial Fluid Glucose Sensor

NCT05251116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2023-08-04

No results posted yet for this study

Summary

To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.

Conditions

  • Diabete Mellitus

Interventions

DEVICE

FreeStyle Libre

FreeStyle Libre 2 continuous Glucose Monitoring System

Sponsors & Collaborators

  • Abbott Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Shridhara A Karinka, PhD · Abbott Diabetes Care

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-11
Primary Completion
2022-07-20
Completion
2022-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05251116 on ClinicalTrials.gov