N/A N=52 Other

Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02352298 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003) — 28.6; 71.4; 100; 32.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dario Blood Glucose Monitoring System (Device); YSI Analyzer (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LabStyle Innovations Ltd.
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)	28.6; 71.4; 100; 32.5; 60.1; 87.6	—

Summary

The purpose of this study is to assess the performance of the Dario Blood Glucose Monitor (BGMS), at elevated altitudes, by obtaining whole blood fingerstick samples from individuals and analyzing the blood on the Dario Blood Glucose Monitor (BGMS) and comparing the readings to readings obtained from the YSI 2300 STAT Plus glucose analyzer.

Eligibility Criteria

Inclusion Criteria

Age of subject is 18 years or older
Able to speak and read English

Exclusion Criteria

Pregnant
Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02352298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.