DiabetesNCT02461394
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
A study testing Blood glucose monitoring systems for self-testing in people with Diabetes, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
Trial summary
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Blood glucose monitoring systems for self-testing
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
- For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
- Minimum age of 18 years
- Signed informed consent form
- Legally competent and capable to understand character, meaning and consequences of the study
Who cannot join
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Incapability of giving informed consent
- < 18 years
Show all 16Show fewer
- Legally incompetent
- Accommodated in an institution (e.g. psychiatric clinic)
- Language barriers potentially compromising an adequate compliance with study procedures
- Dependent from investigator or sponsor
- For provoked blood glucose excursions 50 - 80 mg/dl:
- Coronary heart disease
- Condition after myocardial infarction
- Cerebral incidence
- Peripheral arterial occlusive disease
- Hypoglycemia unawareness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, 89081
About this study
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
Read more
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
- Conditions
- Diabetes
- Being tested
- Blood glucose monitoring systems for self-testing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose monitoring systems for self-testingDevice
Also called Contour Plus, Accu-Chek Active, Accu-Chek Performa, OneTouch Select Simple
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance criteria defined by ISO 15197:2013 (see description)
95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
Measured: For each subject, the experimental phase has an expected duration of up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461394
- Sponsor's protocol ID
- IDT-1469-BL
- Status last verified
- Jan 2016
- First submitted
- 1 Jun 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
- ClinicalTrials.gov ID
- NCT02461394
- Acronym / sponsor ID
- IDT-1469-BL
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität UlmUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
- For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
- Minimum age of 18 years
- Signed informed consent form
- Legally competent and capable to understand character, meaning and consequences of the study
Key exclusion criteria (16 listed)
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
- Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Incapability of giving informed consent
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 |
|---|---|---|
| Blood glucose monitoring systems for self-testingAlso: Contour Plus, Accu-Chek Active, Accu-Chek Performa, OneTouch Select Simple | Device | – |
Primary outcome
Acceptance criteria defined by ISO 15197:2013 (see description)
Time frame: For each subject, the experimental phase has an expected duration of up to 3 hours
95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose monitoring systems for self-testing in people with Diabetes, run by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm at 1 site in Germany.
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 5 inclusion and 16 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 26 Jan 2016. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptance criteria defined by ISO 15197:2013 (see description) (time frame: For each subject, the experimental phase has an expected duration of up to 3 hours). 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 26 Jan 2016; AzTrials last refreshed its copy on 5 Nov 2026.