NCT02916563

Brief Summary

This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 6, 2020

Completed
Last Updated

November 19, 2020

Status Verified

October 1, 2020

Enrollment Period

Same day

First QC Date

September 26, 2016

Results QC Date

August 19, 2020

Last Update Submit

October 25, 2020

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of Successful Glucose Readings

    The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL).

    One day

Study Arms (1)

Altitude

EXPERIMENTAL

Single arm study Blood Glucose Monitoring System Altitude Performance

Device: Blood Glucose Monitoring System Altitude Performance

Interventions

Blood Glucose Monitoring System Altitude PerformanceDEVICE

Performance as assessed against a reference method at an altitude of approximately 10,000 feet.

Altitude

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak and read English

You may not qualify if:

  • Pregnant
  • Has any condition that the principle 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

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Satish K. Garg
Organization
Barbara Davis Center for Childhood Diabetes
satish.garg@ucdenver.edu
3037246713

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 26, 2016

First Posted

September 27, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 19, 2020

Results First Posted

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)