Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report

NCT02910674 | Completed Results

• 1 other identifier: CP-0004
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Accuracy of Glucose Concentrations (%)

  Accuracy acceptability is defined as follows: Ninety-five percent (95%) of the individual glucose results shall fall within +/-15 mg/dL of the results of the Dario's measurement at glucose concentrations \< 75 mg/dL and within +/- 20% at glucose concentrations greater than or equal to 75 mg/dL. The accuracy of the Dario Blood Glucose Monitoring System when used with Android operating system smart mobile devices was assessed against the Yellow Springs Instrument 2300 STAT Plus.

  1 Day

• Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"

  Using a scale of 1-5 where 1-completely fails, 2-unsuccessful, 3-Partially successful, 4-successful, 5-very successful. Average rank of 3.5 ('average'/'successful') or above in question #2 - How would you rate your success in operating Dario™ BGMS?

  1 Day

• Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"

  Using a scale of 1-5 where 1-very hard, 2-hard, 3-average, 4-easy, 5-very easy. An average rank of 3 ('average') or above in question #3 - How easy was it to operate the Dario™ BGMS on the first time?

  1 Day

• Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"

  The acceptance criteria for this question is: at least ninety percent (90%) need to answer 'Yes' on question #1 - Did you successfully obtain measurement result using the Dario™ BGMS? 100% of subjects (102 of 102) answered "Yes" to this question.

  1 Day

Study Arms (1)

One Arm

OTHER

This is a comparative diagnostic study, no interventional actions are being taken.

Device: Dario Blood Glucose Monitoring System

Interventions

Dario Blood Glucose Monitoring System DEVICE

Accuracy with usability assessment

One Arm

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has Type 1 or Type II diabetes
• Subject speaks and reads English proficiently
• Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study)

You may not qualify if:

• Subject has medical training or works in the field of blood glucose monitoring systems.
• Subject is critically ill.
• Subject has an impairment that prevents him/her from following the study procedures.
• Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
• Hematocrit levels outside the range of 20%-60%.

Sponsors & Collaborators

• LabStyle Innovations Ltd.: lead

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Satish K. Garg
• Organization: Barbara Davis Center for Childhood Diabetes

satish.garg@ucdenver.edu

303.724.6713

Publication Agreements

• PI is Sponsor Employee: Yes

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: September 20, 2016
• First Posted: September 22, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2021-03

Locations

US (1)