Diabetes Mellitus
Conditions
Brief summary
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
Detailed description
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.
Interventions
Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
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 years 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 (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 |
|---|---|---|
| Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results | One hour | Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Rated as <=3 (Labeling Comprehension) | One hour | Study staff rated participants as to their success at performing meter testing. 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.) |
| Percentage of Participant Ratings for Overall Testing Experience With This Meter | One hour | Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor 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 with blood obtained from the palm and forearm | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Subjects With Diabetes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
Time frame: One hour
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results | Results from palm (subject blood) (n=101) | 96 number of AST Blood Glucose Results |
| Subjects With Diabetes | Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results | Results from forearm (subject blood) (n=100) | 93 number of AST Blood Glucose Results |
Secondary
Percentage of Participant Ratings for Overall Testing Experience With This Meter
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).
Time frame: One hour
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Percentage of Participant Ratings for Overall Testing Experience With This Meter | 4 Excellent | 68 percent of participants |
| Subjects With Diabetes | Percentage of Participant Ratings for Overall Testing Experience With This Meter | 3 Very Good | 26 percent of participants |
| Subjects With Diabetes | Percentage of Participant Ratings for Overall Testing Experience With This Meter | 2 Good | 6 percent of participants |
| Subjects With Diabetes | Percentage of Participant Ratings for Overall Testing Experience With This Meter | 1 Poor | 0 percent of participants |
| Subjects With Diabetes | Percentage of Participant Ratings for Overall Testing Experience With This Meter | 0 Unacceptable | 0 percent of participants |
Secondary
Percentage of Participants Rated as <=3 (Labeling Comprehension)
Study staff rated participants as to their success at performing meter testing. 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) | Fingerstick glucose result | 100 percent of participants |
| Subjects With Diabetes | Percentage of Participants Rated as <=3 (Labeling Comprehension) | Alternative site glucose result | 100 percent of participants |