An interventional study of Apollo Blood Glucose Monitoring System in Diabetes Mellitus, 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 performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects.
The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 102 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →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 (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
Device: Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).
Also known as: CONTOUR® USB
Number of Capillary and Venous 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. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.
Time frame: One hour
Percentage of Participants Rated as <=3 (Labeling Comprehension)
Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was: 1. Successful 2. Successful after being referred to user instructions 3. Successful with 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: One hour
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).
Time frame: One hour
| Milestone | Subjects With Diabetes |
|---|---|
| Started | 102 |
| Completed | 101 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.
| number of blood glucose (BG) results | Subjects With Diabetes |
|---|---|
| Subjects: Capillary Plasma (n=300) | 273 |
| HCPs: Capillary Plasma (n=300) | 274 |
| Subjects: Capillary Whole Blood (n=300) | 280 |
| HCPs: Capillary Whole Blood (n=299) | 273 |
| HCPs: Venous Plasma (n=605) | 597 |
| HCPs: Venous Whole Blood (n=606) | 603 |
Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was: 1. Successful 2. Successful after being referred to user instructions 3. Successful with 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.)
| percent of participants | Subjects With Diabetes |
|---|---|
| Perform BG measurement (102/102) | 100 |
| Select Before/After Meal(Autolog feature) (99/102) | 97 |
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).
| number of participants | Subjects With Diabetes |
|---|---|
| 4 Excellent | 68 |
| 3 Very Good | 22 |
| 2 Good | 11 |
| 1 Poor | 0 |
| 0 Unacceptable | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Diabetes | — | 0/102 (0%) | 0/102 (0%) |
| Age, Categorical(Participants) | Subjects With Diabetes |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 70 |
| >=65 years | 32 |
| Sex: Female, Male(Participants) | Subjects With Diabetes |
|---|---|
| Female | 61 |
| Male | 41 |
| Region of Enrollment(participants) | Subjects With Diabetes |
|---|---|
| United States | 102 |
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