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Trial Outcomes & Findings for Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report (NCT NCT02910674)

NCT ID: NCT02910674

Last Updated: 2021-04-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

1 Day

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure
Diabetes (Type I or II), Ages 13-80
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Overall Study
STARTED
102
Overall Study
COMPLETED
102
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Diabetes (Type I or II), Ages 13-80
n=102 Participants
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Age, Continuous
33.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male
Female
68 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
6 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
90 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Subjects with Type I and Type II diabetes
102 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

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.

Outcome measures

Outcome measures
Measure
Diabetes (Type I or II), Ages 13-80
n=102 Participants
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Accuracy of Glucose Concentrations (%)
97.4 percentage of measurements within range
Interval 95.0 to 100.0

PRIMARY outcome

Timeframe: 1 Day

Population: 102 ranked their success in operating Dario™ BGMS 1-5. 1- Completely failed, 5- Very successful

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?

Outcome measures

Outcome measures
Measure
Diabetes (Type I or II), Ages 13-80
n=102 Participants
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS"
4.4 score on a scale
Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 1 Day

Population: 102 ranked their ease in operating Dario™ BGMS 1-5. 1- Very Hard, 5- Very Easy

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?

Outcome measures

Outcome measures
Measure
Diabetes (Type I or II), Ages 13-80
n=102 Participants
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?"
3.9 score on a scale
Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 1 Day

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.

Outcome measures

Outcome measures
Measure
Diabetes (Type I or II), Ages 13-80
n=102 Participants
Males and females with diabetes (type I or II), ages 13-80 recruited through advertisement, outpatient clinics, physician offices, and similar sources.
Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?"
102 Participants

Adverse Events

Diabetes (Type I or II), Ages 13-80

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Satish K. Garg

Barbara Davis Center for Childhood Diabetes

Phone: 303.724.6713

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place