N/A
Completed N=136
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
Source: ClinicalTrials.gov NCT02041286 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method — 127 Blood glucose results
Summary
The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method |
127 | — |
| SECONDARY Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method |
131 | — |
| SECONDARY Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method |
112 | — |
| SECONDARY Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff |
133 | — |
| SECONDARY Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements |
136; 136; 136; 136; 136; 136 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 years of age and 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 BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)
- Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- 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 (NCT02041286). 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.