Diabetes
Conditions
Brief 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).
Detailed description
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.
Interventions
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.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 \<18 years of age and adults \>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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Rated as <=3 (Comprehension of Labeling) | 1-2 hours | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | 1-2 hours | 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. |
Countries
United States
Participant flow
Pre-assignment details
5 subjects signed informed consents but did not meet inclusion/exclusion criteria so were not considered enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Diabetes Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood. | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | Subjects With Diabetes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
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
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Perfom blood glucose measurement | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Connect meter to computer via USB port | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Select 'Before'/After' meal in Autolog feature | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Access electronic user guide on Apollo meter | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Set date/time to current by selecting Y at prompt | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Remove meter from computer | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Perform simulated BG test using control solution | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Turn on test strip port light (n=73) | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Access and review Logbook, Reports, and Summary | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Access and review Blood Sugar Trends | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand data for Before/After Meal and 14day | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand Average glucose value | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand BG number within target range | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand BG number above target range | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand BG number below target range | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Was able to turn meter off (n=73) | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Understand Apollo has no replaceable batteries | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Able to charge via USB port and verify charging | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Able to set date and time formats (n=73) | 100 percentage of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Able to change 'Before Meal' target range(n=73) | 100 percentage of participants |
Secondary
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
Population: Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects: Test Results (n=148) | 146 Number of Duplicate Results (n=74x2) |
| Subjects With Diabetes | Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCPs: Test Results (n=148) | 143 Number of Duplicate Results (n=74x2) |