NCT02488278

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

June 23, 2015

Last Update Submit

September 17, 2020

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Keywords

Glucose blood measurements, glucometers ,audio communication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to completion of obtaining a glucose reading using the application and device

    1 Hour

  • Frequency of attempts to ask for assistance during the use of the device and application

    1 hour

  • Participants' level of success in completing tasks related to the use of the device and application

    1 hour

  • Documenting specific user errors and inefficiencies related to the use of the device and application

    1 hour

Study Arms (1)

Self-Monitoring of Glucose Blood Measurements

NO INTERVENTION

Self-Monitoring of Glucose Blood Measurements using the GlucoMe Glucose Monitoring Device and App

Device: GlucoMe Glucose Monitoring Device

Interventions

GlucoMe Glucose Monitoring DeviceDEVICE

Perform a blood glucose test using the application and device

Self-Monitoring of Glucose Blood Measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ahava Stein

    A. Stein Regulatory Affairs Consulting Ltd.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 2, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

September 22, 2020

Record last verified: 2020-09