Trial Outcomes & Findings for Dario™ Blood Glucose Monitoring System - User Performance Evaluation (NCT NCT02053584)

NCT ID: NCT02053584

Last Updated: 2021-12-21

Results Overview

The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 230 participants
• Primary outcome timeframe: Within 6 seconds of applying blood drop to strip
• Results posted on: 2021-12-21

Participant Flow

230 patients were consented, the patients from day one (n=68) were excluded from the final results analysis due to a number of technical issues.

Participant milestones

Measure	Dario BGMS Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
Overall Study STARTED	230
Overall Study COMPLETED	230
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Baseline characteristics by cohort

Measure	Dario BGMS n=161 Participants Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
Age, Continuous	55.5 years STANDARD_DEVIATION 17.6 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	66 Participants n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Region of Enrollment Israel	161 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 seconds of applying blood drop to strip

The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)

Outcome measures

Measure	Dario BGMS n=161 Participants Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.	Dario BGMS (Understood After Few Attempts) Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were understood after few attempts. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.	Dario BGMS (Did Not Understand How to Use) Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were not clear and that they did not understand how to use. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
BGMS Accuracy Assessment When Used by Layperson < 75 mg/dl Within ±5mg/dL	2 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson < 75 mg/dl Within ±10mg/dL	4 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson < 75 mg/dl Within ±15mg/dL	6 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson >= 75 mg/dl Within ±5%	44 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson >= 75 mg/dl Within ±10%	78 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson >= 75 mg/dl Within ±15%	126 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson >= 75 mg/dl Within ±20%	150 percentage of participants	—	—
BGMS Accuracy Assessment When Used by Layperson >= 75 mg/dl	155 percentage of participants	—	—

SECONDARY outcome

Timeframe: Within a couple of hours from the time labelling material was provided to the subject

Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.

Outcome measures

Measure	Dario BGMS n=161 Participants Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.	Dario BGMS (Understood After Few Attempts) n=161 Participants Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were understood after few attempts. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.	Dario BGMS (Did Not Understand How to Use) n=161 Participants Dario™ Blood Glucose Meter: Each subject will undergo a finger prick and also provide a venous blood sample. Subjects reported that the labels were not clear and that they did not understand how to use. YSI2003: Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
Evaluation of the Ease of Use of the Dario BGMS by the Lay-person	93 participants	67 participants	1 participants

Adverse Events

Dario BGMS

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. Julio Weinstein

Wolfson Medical Center

Phone: 972-3-5028371

Email: vainstein@wolfson.health.gov.il

Results disclosure agreements

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