N/A
N=74
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00804596 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Percentage of Participants Rated as <=3 (Comprehension of Labeling) — 100; 100; 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Apollo Blood Glucose Monitoring System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Rated as <=3 (Comprehension of Labeling) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method |
146; 143 | — |
Summary
The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).
Eligibility Criteria
Inclusion Criteria
- Have type 1 or type 2 diabetes
- Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent
- Be willing to complete all study procedures
- Be routinely testing their blood sugar at home (at least once per day)
- Be able to speak, read, and understand English and understand the Informed Consent document
- Be able to read the labeling instructions
- Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required.
Exclusion Criteria
- Minors 75 years of age
- Pregnancy
- Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
- Disorders in the fingertip lancing areas
- Acute or chronic infections, particularly skin infections
- Infection with a blood borne pathogen
- Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion
- Hemophilia or any other bleeding disorder
- Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
- Working for a competitive medical device company
Data sourced from ClinicalTrials.gov (NCT00804596). 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.