N/A
Completed N=372
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
Source: ClinicalTrials.gov NCT02150109 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Jul 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 — 317 Blood glucose results within 15mg/dL/15%
Summary
The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood 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 |
317 | — |
| 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 |
318 | — |
| SECONDARY Number of 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 |
325 | — |
| SECONDARY Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements |
326; 329; 329; 326; 328; 326 | — |
| SECONDARY Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range |
353 | — |
| SECONDARY Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range |
359 | — |
| SECONDARY Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff |
365 | — |
| SECONDARY Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff |
367 | — |
| SECONDARY Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements |
368; 371; 371; 368; 369; 368 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 years of age and older
- 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 Contour BGMS (or used a Bayer Contour meter)
- Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Work 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
General enrollment guidelines:
- Most subjects will be persons with type 1 or type 2 diabetes
- At least 10% of subjects with diabetes will have type 1 diabetes
- Approximately 10% of subjects will be persons without diabetes
- At least 60% of subjects will be younger than age 65
Data sourced from ClinicalTrials.gov (NCT02150109). 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.