Diabetes
Conditions
Brief summary
The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.
Interventions
DEVICEContour TS Blood Glucose Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of 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 puncture site (at the discretion of the site professional staff). * 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 Contour TS system or use the Contour TS 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma). |
| Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma). |
| Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | 1 hour | Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Continuous | 55 years |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).
Time frame: 1 hour
Population: 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 84 Number of BG Test Results |
Secondary
Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).
Time frame: 1 hour
Population: 102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 83 Number of BG Test Results |
Secondary
Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (\<100mg/dL YSI capillary plasma) or +/- 15% (\>=100mg/dL YSI capillary plasma).
Time frame: 1 hour
Population: 102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 78 Number of BG Test Results |
Secondary
Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements
Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | I found it easy to do a blood test w this meter | 98 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Meter display (test result) is easy to read | 102 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Easy to see and understand the test results | 101 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | I like the overall meter design | 80 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Meter is easy to handle | 90 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Easy to handle the individual test strips | 64 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Instructions (User Guide) easy to understand | 97 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Instructions clearly explain how to run a test | 101 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | Instructions clearly explain meter error message | 98 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | I found this meter easy to use | 100 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | I found this meter intuitive | 96 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements | I found this meter practical | 97 participants |