Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.
Detailed description
This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.
Interventions
DEVICEContour Next and Contour Plus Elite BGMS testing of neonatal blood
The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.
Sponsors
Ascensia Diabetes Care
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
0 Days to 27 Days
Healthy volunteers
No
Inclusion criteria
* Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing. * Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.
Exclusion criteria
* Samples from subjects who are ≥ 28 days of age. * Samples from subjects who have previously been enrolled into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values | 1 day | At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L). |
| Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values | 1 day | At least 95% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testing of Neonatal Blood With BGMS The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. The results will be compared to the laboratory reference result. | 120 |
| Testing of Neonatal Blood With BGMS The neonatal blood will be tested on two different BGMS: 1) Contour Next BGMS and 2) Contour Plus Elite BGMS. The results will be compared to the laboratory reference result. | 240 |
| Total | 360 |
Baseline characteristics
| Characteristic | Testing of Neonatal Blood With BGMS |
|---|---|
| Age, Categorical <=18 years | 120 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 120 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).
Time frame: 1 day
Population: Neonates in a hospital neonatal unit.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Testing of Neonatal Blood With BGMS | Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values | 240 blood samples |
Primary
Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values
At least 95% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \< 75 mg/dL(4.16 mmol/L).
Time frame: 1 day
Population: Neonates in a neonatal hospital ward.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Testing of Neonatal Blood With BGMS | Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values | 240 blood samples |