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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour Next and Contour Plus Elite BGMS testing of neonatal blood | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day |
| 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). | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will consist of neonates from hospital wards (e.g. routine/newborn nurseries, SCN, NICU) of the clinical investigational site.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Dietzen, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital, Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Each blood sample will be tested in duplicate on each BGMS. The results will be compared to the laboratory reference result. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
120 participants were enrolled in the study. Each participant provided 2 blood samples that were tested. So, the number of results analyzed is 240.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Neonates in a hospital neonatal unit. | Posted | Count of Units | blood samples | 1 day | blood samples | blood samples |
|
1 day
No adverse reactions expected since the samples were leftover blood. No contact with the neonate was made.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes Care | 5748501467 | jane.wallace@ascensia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2022 | Oct 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| blood samples |
|
| Participants |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
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| Units | Counts |
|---|
| Participants |
|
| 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). | Neonates in a neonatal hospital ward. | Posted | Count of Units | blood samples | 1 day | blood samples | blood samples |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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