GLUCOME USABILITY STUDY

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: GlucoMe Glucose Monitoring Device

Detailed Description

Twenty (20) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. 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 and QuickStart guide. An additional ten (10) subjects also identified as potential end users of the GlucoMe device will not receive the user manual, but will receive the QuickStart guide. 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 examination 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is male or female equal to or greater than 18 years of age.
2. Subject is a potential candidate for purchasing the GlucoMe device (e.g., subjects diagnosed with diabetes type 1 or 2).
3. Subject has facility with both hands.
4. Subject monitors himself.
5. Subject knows how to download and install apps.
6. Subject is capable of understanding and is willing to sign informed consent.

Exclusion Criteria:

1. Subject has dementia.
2. Subject has mental disorders.
3. Subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
4. Subject does not monitor himself.
5. Subject is visually impaired.
6. Subject cannot draw blood samples from fingertip.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Self-Monitoring of Glucose Blood Measurements; Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App	Device: GlucoMe Glucose Monitoring Device; Perform a blood glucose test using the application and device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating the GlucoMe device: obtaining a glucose reading and recording the results	Using the device, with or without the user manual, all 20 subjects tested were able to complete device related tasks, including starting the application, operating the GlucoMe device and obtaining a glucose reading and recording the results, in a timeframe of up to 1 hour and with minimal attempts to ask for assistance; and Using the device and the user manual. Considering that the GlucoMe is a low risk device, and the probability of an occurrence and the severity of a failure are low, a success rate of 100% potential end user subjects passing may be considered acceptable for the over the counter use of the device. Any failures to complete the device related tasks and/or self-exclude from use of the device must be explained.	1 Hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to completion of obtaining a glucose reading using the application and device	The following measurable usability criteria for specific, critical steps, based on observer evaluation or user post-test questionnaire responses, will be assessed through analysis of the data following the study: Time-to-completion of task; Time to completion of obtaining a glucose reading using the application and device will be measured by the observer for both arms and will be analysed	1 Hour
Frequency of attempts to ask for assistance during the use of the device and application	Frequency of attempts to ask for assistance will be documented by the observer for both arms and will be analysed	1 hour
Participants' level of success in completing tasks related to the use of the device and application	Numerical ratings describing the participants' level of success in completing tasks will be collected through user post-test questionnaire responses, for both arms and will be analysed	1 hour
Documenting specific user errors and inefficiencies related to the use of the device and application	Qualitative information regarding specific user errors and inefficiencies will be collected through observer evaluation and user post-test questionnaire responses, for both arms and will be analysed	1 hour

Collaborators and Investigators

• Sponsor: GlucoMe
• Investigators: Study Director: Ahava Stein, A. Stein Regulatory Affairs Consulting Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Glucose blood measurements, glucometers ,audio communication
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Clin-001-00