Diabetes Mellitus, Type 1NCT02488278

GLUCOME USABILITY STUDY

A study testing GlucoMe Glucose Monitoring Device in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by GlucoMe.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being tested?: GlucoMe Glucose Monitoring Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jul 2015to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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.

Read the 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.

Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Being tested: GlucoMe Glucose Monitoring Device
Keywords: Glucose blood measurements, glucometers ,audio communication
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlucoMe Glucose Monitoring DeviceDevice
Perform a blood glucose test using the application and device

Study groups in NCT02488278
Study group	Role	What they receive
Self-Monitoring of Glucose Blood Measurements	No intervention	Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App Receives: Device: GlucoMe Glucose Monitoring Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 Hour

Secondary outcomes (4)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Oct 2015

First posted2 Jul 2015 (estimated)
Study startJul 2015
Primary completionSep 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02488278
Sponsor's protocol ID: Clin-001-00
Status last verified: Sep 2020
First submitted: 23 Jun 2015
Last updated: 22 Sep 2020
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
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Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
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Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GLUCOME USABILITY STUDY
ClinicalTrials.gov ID: NCT02488278
Acronym / sponsor ID: Clin-001-00
Conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords: Glucose blood measurements, glucometers ,audio communication
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: GlucoMeIndustry (pharma, biotech, devices)
Study start: Jul 2015
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 2 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Self-Monitoring of Glucose Blood Measurements	No intervention	Device: GlucoMe Glucose Monitoring DeviceSelf-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

Subject has dementia.
Subject has mental disorders.
Subject was diagnosed with diabetes other than type 1 or 2 (e.g. gestational diabetes, congenital diabetes, drug induced diabetes, etc.).
Subject does not monitor himself.
Subject is visually impaired.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlucoMe Glucose Monitoring DevicePerform a blood glucose test using the application and device	Device	Self-Monitoring of Glucose Blood Measurements

Primary outcome

Operating the GlucoMe device: obtaining a glucose reading and recording the results
Time frame: 1 Hour
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.

4 secondary outcomes

Time to completion of obtaining a glucose reading using the application and device
Time frame: 1 Hour
Frequency of attempts to ask for assistance during the use of the device and application
Time frame: 1 hour
Participants' level of success in completing tasks related to the use of the device and application
Time frame: 1 hour
Documenting specific user errors and inefficiencies related to the use of the device and application
Time frame: 1 hour

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.

Related trials for Diabetes Mellitus, Type 1

Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ahava Stein study director

A. Stein Regulatory Affairs Consulting Ltd.

Questions about this trial

What is this clinical trial studying?

A study testing GlucoMe Glucose Monitoring Device in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by GlucoMe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operating the GlucoMe device: obtaining a glucose reading and recording the results (time frame: 1 Hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02488278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.