Performance of an Investigational Blood Glucose Monitoring System
NCT01824355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2016-02-29
Summary
The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Conditions
Interventions
- DEVICE
-
Ninja 3 PLUS Investigational BG Monitoring System
Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.
Sponsors & Collaborators
-
Ascensia Diabetes Care
lead INDUSTRY
Principal Investigators
-
Michael Caswell, PhD · Consumer Product Testing Co.
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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