N/A
Completed N=207
Study of an Investigational Glucose Meter System
Source: ClinicalTrials.gov NCT01466075 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method — 99.51 percentage of Blood Glucose Test Results
Summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-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 +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method |
99.51 | — |
| SECONDARY Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method |
99.51 | — |
| SECONDARY Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method |
100.0 | — |
| SECONDARY Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction |
203; 203 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of diabetes or pre-diabetes.
- Be 18 years of age or older
- Be able to speak, read and understand English and understand the Informed Consent document.
- Be willing to complete study procedures
Exclusion Criteria
- Pregnancy
- Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
- Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
- Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
- A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
- Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
- Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
- Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
Data sourced from ClinicalTrials.gov (NCT01466075). 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.