MedTrace Logo

GLUCOME USABILITY STUDY

NCT02488278 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-22

No results posted yet for this study

Summary

The GlucoMe device, in its original packaging, along with the user manual and QuickStart guide will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution.

Ten (10) subjects identified as potential end users of the GlucoMe device will receive the user manual. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will NOT receive the user manual. All subjects will be provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device.

The observer and user post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DEVICE

GlucoMe Glucose Monitoring Device

Perform a blood glucose test using the application and device

Sponsors & Collaborators

  • GlucoMe

    lead INDUSTRY

Principal Investigators

  • Ahava Stein · A. Stein Regulatory Affairs Consulting Ltd.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-09-30
Completion
2015-10-31

More Related Trials

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 NCT02488278 on ClinicalTrials.gov