Diabetes MellitusNCT05467345
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
An observational study of Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 27 days
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Contour Next and Contour Plus Elite BGMS testing of neonatal blood
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 14 Mar 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 27 days
- All sexes
- No healthy volunteers
- Child
Study population: The subject population will consist of neonates from hospital wards (e.g. routine/newborn nurseries, SCN, NICU) of the clinical investigational site.
Who may be able to join
- 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.
Who cannot join
- Samples from subjects who are ≥ 28 days of age.
- Samples from subjects who have previously been enrolled into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital, Washington University
St Louis, Missouri, 63110
About this study
Official title: Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Contour Next and Contour Plus Elite BGMS testing of neonatal blood
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour Next and Contour Plus Elite BGMS testing of neonatal bloodDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start24 Aug 2022
- Primary completion30 Nov 2022
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Dietzen, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467345
- Sponsor's protocol ID
- GCA-PRO-2021-003-01
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2022
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
- ClinicalTrials.gov ID
- NCT05467345
- Acronym / sponsor ID
- GCA-PRO-2021-003-01
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 27 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The subject population will consist of neonates from hospital wards (e.g. routine/newborn nurseries, SCN, NICU) of the clinical investigational site.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Samples from subjects who are ≥ 28 days of age.
- Samples from subjects who have previously been enrolled into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contour Next and Contour Plus Elite BGMS testing of neonatal bloodThe 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. | Device | – |
Primary outcome
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Dietzen, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.