N/A
Completed N=113
Performance of an Investigational Blood Glucose Monitoring System
Source: ClinicalTrials.gov NCT01824355 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method — 99.09 percentage of BG results
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method |
99.09 | — |
| SECONDARY Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method |
97.73 | — |
| SECONDARY Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method |
93.64 | — |
| SECONDARY Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method. |
97.13 | — |
| SECONDARY Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff |
100.0 | — |
| SECONDARY Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements |
108; 108; 108; 106; 106; 105 | — |
Eligibility Criteria
- Inclusion Criteria:
- Males and females, 18 years of age or older.
- People with type 1 or type 2 diabetes.
- Able to speak, read and understand English.
- Willing to complete all study procedures.
- Exclusion Criteria:
- Hemophilia or any other bleeding disorder.
- Pregnancy.
- Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
- Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
- Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
- Working for a competitive medical device company, or having an immediate family member who works for such a company.
- A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.
Data sourced from ClinicalTrials.gov (NCT01824355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.