DiabetesNCT01756274
Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates
A study testing Contour® NEXT BGMS, Contour® PLUS BGMS and Contour® Next EZ BGMS in people with Diabetes, run by Ascensia Diabetes Care at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Read more about this study
- Who is it for?
- Ages Up to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Contour® NEXT BGMS, Contour® PLUS BGMS and Contour® Next EZ BGMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2013
- Phase
- Interventional
- 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 Up to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Routine blood samples (heelstick) collected from neonates (less than 30 days of age).
- A portion of the samples (approximately 10%) will be from subjects <24 hours old.
- A portion of the samples (at least 10%) will be from subjects in the NICU.
- Sample blood volume must be sufficient to complete investigational testing in addition to prescribed testing.
Who cannot join
- Samples from babies >=30 days of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates
The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).
- Conditions
- Diabetes
- Being tested
- Contour® NEXT BGMS, Contour® PLUS BGMS, Contour® Next EZ BGMS
- 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 BGMSDevice
Lab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Contour® PLUS BGMSDevice
Lab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Contour® Next EZ BGMSDevice
Lab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
| Study group | Role | What they receive |
|---|---|---|
| Neonates 'Left-over' Blood Samples | Experimental | Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Two left-over samples could be obtained from a single neonate. Laboratory professionals tested the BG concentration using three Bayer Blood Glucose Monitoring Systems (BGMS): Contour® NEXT BGMS, Contour® PLUS BGMS, and Contour® Next EZ BGMS. Receives: Device: Contour® NEXT BGMS; Device: Contour® PLUS BGMS; Device: Contour® Next EZ BGMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value
Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Measured: 30 minutes
Secondary outcomes (1)
Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value
Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis J Dietzen, PhD, DABCC, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756274
- Sponsor's protocol ID
- CTD-2010-009-03
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2012
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates
- ClinicalTrials.gov ID
- NCT01756274
- Acronym / sponsor ID
- CTD-2010-009-03
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Dec 2012 (estimated)
- Results
- Posted 9 Apr 2014
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 was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates 'Left-over' Blood Samples | Experimental | Device: Contour® NEXT BGMS, Device: Contour® PLUS BGMS, Device: Contour® Next EZ BGMSBlood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Two left-over samples could be obtained from a single neonate. Laboratory professionals tested the BG concentration using three Bayer Blood Glucose Monitoring Systems (BGMS): Contour® NEXT BGMS, Contour® PLUS BGMS, and Contour® Next EZ BGMS. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Routine blood samples (heelstick) collected from neonates (less than 30 days of age).
- A portion of the samples (approximately 10%) will be from subjects <24 hours old.
- A portion of the samples (at least 10%) will be from subjects in the NICU.
- Sample blood volume must be sufficient to complete investigational testing in addition to prescribed testing.
Key exclusion criteria (1 listed)
- Samples from babies >=30 days of age
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 BGMSLab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | Device | Neonates 'Left-over' Blood Samples |
| Contour® PLUS BGMSLab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | Device | Neonates 'Left-over' Blood Samples |
| Contour® Next EZ BGMSLab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | Device | Neonates 'Left-over' Blood Samples |
Primary outcome
Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value
Time frame: 30 minutes
Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
1 secondary outcome
Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 J Dietzen, PhD, DABCC 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?
A study testing Contour® NEXT BGMS, Contour® PLUS BGMS and Contour® Next EZ BGMS in people with Diabetes, 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 4 inclusion and 1 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 15 Feb 2017. 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 9 Apr 2014). 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?
Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value (time frame: 30 minutes). 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 15 Feb 2017.