Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.
Interventions
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a 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
4 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Age 4 to 24 years * Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment * Has used a handheld game system to play video games within a year of enrollment * If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision. * Is willing to complete all study procedures, with appropriate parent/guardian supervision
Exclusion criteria
* Hemophilia or any other bleeding disorder * Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded * Infection with a blood borne pathogen (e.g., HIV, hepatitis) * Subject or parent/guardian is employee of competitive medical device company * Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | 1-2 hours | Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated. |
| Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results | 1-2 hours | Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values \<75mg/dL) and within +/- 20% (for reference BG values \>= 75mg/dL)of the HCP results was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | 1-2 hours | The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences |
| Number of Participants Rated as <=2 (Labeling Comprehension) | 1-2 hours | Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows: 1. Successful in performing tasks correctly without assistance 2. Successful after study staff prompted participant to review User Guide. 3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.) 4. Subject did not perform task correctly and study staff intervention was required. |
| Average Within Replicate Coefficient of Variation CV (Precision) | 1-2 hours | The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root. |
Countries
United States
Participant flow
Recruitment details
Subjects actually recruited ranged in age from 5 to 24 years old. Subjects under age 18 were accompanied by a parent or guardian.
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable. | 147 |
| Total | 147 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Customized 13-17 years of age | 54 participants |
| Age, Customized 18-24 years of age | 38 participants |
| Age, Customized 4-12 years of age | 55 participants |
| Region of Enrollment United States | 147 participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 147 |
| serious Total, serious adverse events | 0 / 147 |
Outcome results
Primary
Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values \<75mg/dL) or +/- 20% (for reference blood glucose values \>/= 75mg/dL)of the reference results were calculated.
Time frame: 1-2 hours
Population: Some subjects \>=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | HCP Test Results (n=157) | 143 number of capillary results (n=79x2) |
| Intended Users of the Monitoring System | Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects' Test Results (n=158) | 142 number of capillary results (n=79x2) |
Primary
Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values \<75mg/dL) and within +/- 20% (for reference BG values \>= 75mg/dL)of the HCP results was calculated.
Time frame: 1-2 hours
Population: One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results | 277 number of Subject BGM Results (n=146x2) |
Secondary
Average Within Replicate Coefficient of Variation CV (Precision)
The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.
Time frame: 1-2 hours
Population: Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Average Within Replicate Coefficient of Variation CV (Precision) | Average Subject (144) Coefficient of Variation CV | 5.9 percentage CV |
| Intended Users of the Monitoring System | Average Within Replicate Coefficient of Variation CV (Precision) | Average HCP (145) Coefficient of Variation CV | 7.2 percentage CV |
Secondary
Number of Participants Rated as <=2 (Labeling Comprehension)
Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows: 1. Successful in performing tasks correctly without assistance 2. Successful after study staff prompted participant to review User Guide. 3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.) 4. Subject did not perform task correctly and study staff intervention was required.
Time frame: 1-2 hours
Population: For 2 different subjects, study staff did not rate subject success at 1 task.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Participants Rated as <=2 (Labeling Comprehension) | Run control solution (n=146) | 144 participants |
| Intended Users of the Monitoring System | Number of Participants Rated as <=2 (Labeling Comprehension) | Put strip into the meter (n=146) | 146 participants |
| Intended Users of the Monitoring System | Number of Participants Rated as <=2 (Labeling Comprehension) | Turn meter on and off (n=147) | 147 participants |
| Intended Users of the Monitoring System | Number of Participants Rated as <=2 (Labeling Comprehension) | Set time and date (n=147) | 137 participants |
| Intended Users of the Monitoring System | Number of Participants Rated as <=2 (Labeling Comprehension) | Switch from level 1 to level 2 features (n=147) | 135 participants |
Secondary
Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences
Time frame: 1-2 hours
Population: Some subjects \>=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject's results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | Zone A | 146 Number of BG results in zone (n=79x2) |
| Intended Users of the Monitoring System | Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | Zone B | 11 Number of BG results in zone (n=79x2) |
| Intended Users of the Monitoring System | Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | Zone C | 1 Number of BG results in zone (n=79x2) |
| Intended Users of the Monitoring System | Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | Zone D | 0 Number of BG results in zone (n=79x2) |
| Intended Users of the Monitoring System | Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | Zone E | 0 Number of BG results in zone (n=79x2) |