Diabetes Mellitus
Conditions
Keywords
diabetes, BGMS, blood glucose monitoring system, fingerstick, AST self-test, YSI Glucose Analyzer
Brief summary
L-PLUS (Lightning PLUS) is the code name of a blood glucose monitoring system (BGMS) consisting of a new meter and marketed CONTOUR PLUS® test strip. This clinical trial will assess the performance (accuracy) of the L-PLUS meter by lay users with diabetes enrolled as subjects in the study, and by health care professionals (also called study staff). The trial will follow the requirements and procedures described in ISO 15197:2013 International Standard.
Detailed description
This study is designed to satisfy the ISO 15197:2013, Section 8 requirements. The study will be conducted at a minimum of one clinical site and enroll a total of approximately 130 persons with diabetes. For this study, there must be at least 120 evaluable results each for fingerstick and AST self-test results, as well as for staff testing subject fingertip and venous blood using the L-PLUS BGMS. Subject enrollment will continue until the required evaluable samples are collected. The subjects will be 18 years and older. Each subject will make one visit, lasting approximately 1 hour at the clinical site. All subjects will complete the informed consent process before performing any study procedures. All Subjects will be assigned a L-PLUS meter and one Contour Plus test strip lots. The untrained subjects will learn to use the L-PLUS meter by reading the instructional materials. Each subject will perform one fingerstick self-test, one palm test, and staff will perform a fingerstick test on the subject. Subjects will be given a venipuncture and the venous blood will be tested by the study staff with the L-PLUS system. All subject capillary and AST self-test results and study staff fingerstick results will be compared to YSI fingerstick results. Venous blood meter tests will be compared to YSI results of the corresponding venous blood. Hematocrit will be measured for all subjects. All Subjects will then complete a questionnaire (Questionnaire 1) to provide feedback on the meter system and instructions for use.
Interventions
DEVICEL-PLUS meter
Blood Glucose Monitoring System
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All subjects will be assigned to use the L-PLUS meter
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females, 18 years of age and older * People with diabetes (PWD) - type 1 or type 2 * Ability to speak, read and understand English. Subjects must demonstrate ability to read a paragraph from the first page of the UG to qualify for the study. * Willing to complete all study procedures
Exclusion criteria
* Hemophilia or any other bleeding disorder * Pregnancy (self-reported) * Physical, visual or neurological impairments that would make the person unable to perform testing with the BGMS. * Previous participation in a blood glucose monitoring study using the Ascensia's Contour Next (Lightning Next) and Lightning PLUS (L-PLUS or Contour Plus ELITE) BGMS. * Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose monitors. * Being in this trial during or less than two days since xylose absorption testing (Xylose in the blood is known to cause interference). * 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. * A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk. The reason for exclusion will be clearly documented by investigator or designee on the subject disposition form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test | Day 1 | Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST) | Day 1 | Accuracy of BGMS test with palm blood. The results of the palm blood meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria |
| Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood | Day 1 | Accuracy of BGMS using venous blood compared to the reference analyzer for all subjects using pre-specified accuracy criteria |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Untrained Subjects With Diabetes Use the L-PLUS BGMS Untrained subjects with Diabetes test capillary fingerstick and palm blood (and study staff test subject fingerstick blood) using the L-PLUS BGMS. All blood glucose results are compared to reference method results obtained with subject capillary plasma. Also, study staff test venous blood and blood glucose results are compared to reference method results obtained from subject venous plasma.
L-PLUS meter: Blood Glucose Monitoring System | 130 |
| Total | 130 |
Baseline characteristics
| Characteristic | Untrained Subjects With Diabetes Use the L-PLUS BGMS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Age, Continuous | 54.4 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Region of Enrollment United States | 130 Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 130 |
| other Total, other adverse events | 0 / 130 |
| serious Total, serious adverse events | 0 / 130 |
Outcome results
Primary
Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test
Accuracy of BGMS test with fingerstick blood. The results of the fingerstick meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria.
Time frame: Day 1
Population: Persons with diabetes perform finger stick tests.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects With Diabetes Use the L-PLUS BGMS | Accuracy of BGMS Compared to the Reference Analyzer - Fingerstick Blood Test | 127 Participants |
Secondary
Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST)
Accuracy of BGMS test with palm blood. The results of the palm blood meter test performed by the participant will be compared to results of the same blood on a laboratory reference analyzer using pre-specified accuracy criteria
Time frame: Day 1
Population: Persons test their blood from palm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects With Diabetes Use the L-PLUS BGMS | Accuracy of BGMS Compared to the Reference Analyzer - Palm Alternative Site Test (AST) | 119 Participants |
Secondary
Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood
Accuracy of BGMS using venous blood compared to the reference analyzer for all subjects using pre-specified accuracy criteria
Time frame: Day 1
Population: Venous blood is tested on each participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Untrained Subjects With Diabetes Use the L-PLUS BGMS | Accuracy of BGMS Compared to the Reference Analyzer - Venous Blood | 129 Participants |