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Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System

NCT05833100 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-02-29

Study results available
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Summary

The goal of this clinical trial is to assess the accuracy and usability of the blood glucose meter in untrained participants, both with or without diabetes, as well as those with pre-diabetes.

Conditions

Interventions

DEVICE

CareSens PRO GK Blood Glucose/b-Ketone Monitoring system

All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood. All Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Rainier Clinical Research Center

    collaborator OTHER

  • i-SENS, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-09-26
Completion
2023-02-23
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 NCT05833100 on ClinicalTrials.gov