Trial Outcomes & Findings for Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study (NCT NCT02916563)

NCT ID: NCT02916563

Last Updated: 2020-11-19

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: One day
• Results posted on: 2020-11-19

Participant Flow

Participant milestones

Measure	Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes. 1. Age of subject is 18 years or older 2. Able to speak and read English
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes n=50 Participants A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes. 1. Age of subject is 18 years or older 2. Able to speak and read English
Age, Continuous	44.9 years STANDARD_DEVIATION 18.5 • n=50 Participants
Sex: Female, Male Female	28 Participants n=50 Participants
Sex: Female, Male Male	22 Participants n=50 Participants

PRIMARY outcome

Timeframe: One day

Population: Each subject will be measured 9 times with the Dario system: 3 strips lots for each of the three representative smart mobile devices (total of nine meters) under evaluation (150 strips per mobile device, total no. of strips 450).

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).

Outcome measures

Measure	Individuals With Type 1 or Type 2 Diabetes and Individuals Without Diabetes n=450 Glucose readings A total of 50 subjects diagnosed with type 1 or type 2 diabetes and individuals without diabetes. 1. Age of subject is 18 years or older 2. Able to speak and read English
Number of Successful Glucose Readings	449 Number of Glucose readings in range

Adverse Events

Altitude

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: 3037246713

Email: satish.garg@ucdenver.edu

Results disclosure agreements

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