Diabetes
Conditions
Brief summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Interventions
DEVICEApollo Evolution Investigational BG Monitoring System
Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
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 or pre-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 site of the venipuncture (at the discretion of the phlebotomist). * 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 a similar device or use a similar device 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 |
|---|---|---|
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational 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 (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST 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 BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). |
| Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma). |
| Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | 1 hour | After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.
Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback. | 207 |
| Total | 207 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Continuous | 55.7 years |
| Region of Enrollment United States | 207 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 207 |
| serious Total, serious adverse events | 0 / 207 |
Outcome results
Primary
Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational 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 (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.
Time frame: 1 hour
Population: Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 99.51 percentage of Blood Glucose Test Results |
Secondary
Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction
After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.
Time frame: 1 hour
Population: Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | Successfully performed fingerstick BG test | 203 participants |
| Intended Users of the Monitoring System | Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | Successfully performed palm AST BG test | 203 participants |
Secondary
Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST 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 BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) or +/- 20% (\>=75mg/dL YSI capillary plasma).
Time frame: 1 hour
Population: Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 99.51 percentage of Blood Glucose Test Results |
Secondary
Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (\<75mg/dL YSI venous plasma) or +/- 20% (\>=75mg/dL YSI venous plasma).
Time frame: 1 hour
Population: 609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 100.0 percentage of Blood Glucose Test Results |