Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.
Interventions
DEVICEDIDGET (Investigational Blood Glucose Monitoring System)
Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.
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 or Type 2 diabetes * Age 4 to 24 years * Routinely performs blood glucose testing at home * If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English. * If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision. * Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate
Exclusion criteria
* Currently pregnant * 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 |
|---|---|---|
| Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method | 1-2 hours | Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Diabetes Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes. | 123 |
| Total | 123 |
Baseline characteristics
| Characteristic | Subjects With Diabetes |
|---|---|
| Age, Customized Age 13 to 17 years | 30 participants |
| Age, Customized Age 18 to 24 years | 52 participants |
| Age, Customized Age 4-12 years | 41 participants |
| Region of Enrollment United States | 123 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 123 |
| serious Total, serious adverse events | 0 / 123 |
Outcome results
Primary
Percent of Blood Glucose (BG) 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 blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results.
Time frame: 1-2 hours
Population: To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Diabetes | Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method | Subject Tests Natural Capillary n=242=2 x 121 | 97.1 percent of blood glucose results |
| Subjects With Diabetes | Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method | Combine Natural+Modified n=336=2 x (121+47) | 97.9 percent of blood glucose results |