Protocol for the Evaluation of Dario™ BGMS Performance at Elevated Altitude
1 other identifier
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedResults Posted
Study results publicly available
June 9, 2017
CompletedJune 9, 2017
May 1, 2017
Same day
January 21, 2015
March 19, 2015
May 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)
Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations \<75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.
6 seconds
Study Arms (2)
Dario Blood Glucose Monitoring System
EXPERIMENTALBlood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System
YSI STAT
ACTIVE COMPARATORBlood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System
Interventions
Fingerstick to obtain blood sample for analysis with the Dario BGMS
Eligibility Criteria
You may qualify if:
- Age of subject is 18 years or older
- Able to speak and read English
You may not qualify if:
- Pregnant
- Has any condition that the principal investigator believes may interfere in the subject's participation in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barbara Davis Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Satish K. Garg
- Organization
- Barbara Davis Center for Childhood Diabetes
Study Officials
- STUDY CHAIR
Christie Beatson
Barbara Davis Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 2, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 9, 2017
Results First Posted
June 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share