An interventional study of Apollo Blood Glucose Monitoring System in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic
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).
The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.
Ascensia Diabetes Care is the lead sponsor of 42 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with diabetes use a new blood glucose monitoring system with subject capillary blood.
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.
Also known as: Commercial name is CONTOUR® USB
Percentage of Participants Rated as <=3 (Comprehension of Labeling)
Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: 1. Successful in performing tasks correctly without assistance 2. Successful after being referred to user instructions 3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
Time frame: 1-2 hours
Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.
Time frame: 1-2 hours
| Milestone | Subjects With Diabetes |
|---|---|
| Started | 74 |
| Completed | 74 |
| Not completed | 0 |
Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: 1. Successful in performing tasks correctly without assistance 2. Successful after being referred to user instructions 3. Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
| percentage of participants | Subjects With Diabetes |
|---|---|
| Perfom blood glucose measurement | 100 |
| Connect meter to computer via USB port | 100 |
| Select 'Before'/"After' meal in Autolog feature | 100 |
| Access electronic user guide on Apollo meter | 100 |
| Set date/time to current by selecting Y at prompt | 100 |
| Remove meter from computer | 100 |
| Perform simulated BG test using control solution | 100 |
| Turn on test strip port light (n=73) | 100 |
| Access and review Logbook, Reports, and Summary | 100 |
| Access and review Blood Sugar Trends | 100 |
| Understand data for Before/After Meal and 14day | 100 |
| Understand Average glucose value | 100 |
| Understand BG number within target range | 100 |
| Understand BG number above target range | 100 |
| Understand BG number below target range | 100 |
| Was able to turn meter off (n=73) | 100 |
| Understand Apollo has no replaceable batteries | 100 |
| Able to charge via USB port and verify charging | 100 |
| Able to set date and time formats (n=73) | 100 |
| Able to change 'Before Meal' target range(n=73) | 100 |
Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.
| Number of Duplicate Results (n=74x2) | Subjects With Diabetes |
|---|---|
| Subjects: Test Results (n=148) | 146 |
| HCPs: Test Results (n=148) | 143 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Diabetes | — | 0/74 (0%) | 4/74 (5.4%) |
| Event | Subjects With Diabetes |
|---|---|
| Cold or flu-like symptoms during the home-use portion of the studyGeneral disorders | 4/74 |
| Age, Categorical(Participants) | Subjects With Diabetes |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 64 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Subjects With Diabetes |
|---|---|
| Female | 40 |
| Male | 34 |
| Region of Enrollment(participants) | Subjects With Diabetes |
|---|---|
| United States | 74 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Ascensia Diabetes Care