Performance of an Investigational Blood Glucose Monitoring System
NCT ID: NCT01824355
Last Updated: 2016-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
113 participants
INTERVENTIONAL
2013-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intended Users of the Monitoring System
Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
1. At least 60% of subjects were younger than 65 years of age.
2. At least 20% had type 1 diabetes.
3. At least 50% with type 2 diabetes were insulin users.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. People with type 1 or type 2 diabetes.
3. Able to speak, read and understand English.
4. Willing to complete all study procedures.
Exclusion Criteria
2. Pregnancy.
3. Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
4. Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
5. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
6. Working for a competitive medical device company, or having an immediate family member who works for such a company.
7. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.
18 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Caswell, PhD
Role: PRINCIPAL_INVESTIGATOR
Consumer Product Testing Co.
Locations
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Consumer Product Testing Co.
Fairfield, New Jersey, United States
Countries
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References
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Caswell M, Brown D, Frank J, Wallace JF, Pardo S. Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps. Curr Med Res Opin. 2020 May;36(5):757-764. doi: 10.1080/03007995.2020.1734919. Epub 2020 Mar 17.
Other Identifiers
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CTD-2012-010-01
Identifier Type: -
Identifier Source: org_study_id