Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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).
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 \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age * 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
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 (81 mg 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 |
|---|---|---|
| Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | One hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Rated as <=3 (Labeling Comprehension) | One hour | 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.) |
| Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | One hour | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Diabetes Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Subjects With Diabetes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
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
Population: One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study.~The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects: Capillary Plasma (n=300) | 273 number of blood glucose (BG) results |
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCPs: Capillary Plasma (n=300) | 274 number of blood glucose (BG) results |
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects: Capillary Whole Blood (n=300) | 280 number of blood glucose (BG) results |
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCPs: Capillary Whole Blood (n=299) | 273 number of blood glucose (BG) results |
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCPs: Venous Plasma (n=605) | 597 number of blood glucose (BG) results |
| Subjects With Diabetes | Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCPs: Venous Whole Blood (n=606) | 603 number of blood glucose (BG) results |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 4 Excellent | 68 number of participants |
| Subjects With Diabetes | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 3 Very Good | 22 number of participants |
| Subjects With Diabetes | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 2 Good | 11 number of participants |
| Subjects With Diabetes | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 1 Poor | 0 number of participants |
| Subjects With Diabetes | Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter | 0 Unacceptable | 0 number of participants |
Secondary
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
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Labeling Comprehension) | Perform BG measurement (102/102) | 100 percent of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Labeling Comprehension) | Select Before/After Meal(Autolog feature) (99/102) | 97 percent of participants |