DiabetesNCT02290067
System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
A study testing Blood glucose monitoring system (Omnitest 3), Blood glucose monitoring system (Omnitest 5) and Blood glucose monitoring system (Omnitest 5D) in people with Diabetes, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus. 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 system (Omnitest 3), Blood glucose monitoring system (Omnitest 5) and Blood glucose monitoring system (Omnitest 5D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Nov 2014
- 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
- Subjects with type 1 or type 2 diabetes and healthy subjects
- Signed and dated informed consent form
- For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
Who cannot join
- Pregnancy or lactation period
- Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
- Mental incapacity or language barriers precluding adequate compliance with the test procedures
- Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
- Legal incompetence or limited legal competence
- Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
- For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
- For system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft
Ulm, 89081
About this study
Official title: EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
- Conditions
- Diabetes
- Being tested
- Blood glucose monitoring system (Omnitest 3), Blood glucose monitoring system (Omnitest 5), Blood glucose monitoring system (Omnitest 5D)
- Keywords
- blood glucose monitoring system, system accuracy
- 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 system (Omnitest 3)Device
Blood glucose monitoring system (Omnitest 5)Device
Blood glucose monitoring system (Omnitest 5D)Device
| Study group | Role | What they receive |
|---|---|---|
| Omnitest 3 | Active comparator | Blood glucose monitoring system Receives: Device: Blood glucose monitoring system (Omnitest 3) |
| Omnitest 5 | Experimental | Blood glucose monitoring system Receives: Device: Blood glucose monitoring system (Omnitest 5) |
| Omnitest 5D | Experimental | Blood glucose monitoring system Receives: Device: Blood glucose monitoring system (Omnitest 5D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
Measured: up to 6 hours
User performance of blood glucose monitoring systems indicated by patient [questionnaire]
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Responsible party
- Sponsor
- Investigators
- Nina Jendrike, Dr. med., Principal investigator, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290067
- Sponsor's protocol ID
- OPM-G-V-1203
- Other IDs
- IDT-1340-BE
- Status last verified
- Dec 2014
- First submitted
- 22 Oct 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATING SYSTEM ACCURACY AND USER PERFORMANCE OF BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
- ClinicalTrials.gov ID
- NCT02290067
- Acronym / sponsor ID
- OPM-G-V-1203
- Conditions
- Diabetes
- Keywords
- blood glucose monitoring system, system accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Nov 2014 (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 aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omnitest 3 | Active comparator | Device: Blood glucose monitoring system (Omnitest 3)Blood glucose monitoring system |
| Omnitest 5 | Experimental | Device: Blood glucose monitoring system (Omnitest 5)Blood glucose monitoring system |
| Omnitest 5D | Experimental | Device: Blood glucose monitoring system (Omnitest 5D)Blood glucose monitoring system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with type 1 or type 2 diabetes and healthy subjects
- Signed and dated informed consent form
- For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)
Key exclusion criteria (8 listed)
- Pregnancy or lactation period
- Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
- Mental incapacity or language barriers precluding adequate compliance with the test procedures
- Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
- Legal incompetence or limited legal competence
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 system (Omnitest 3) | Device | Omnitest 3 |
| Blood glucose monitoring system (Omnitest 5) | Device | Omnitest 5 |
| Blood glucose monitoring system (Omnitest 5D) | Device | Omnitest 5D |
Primary outcome
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment
Time frame: up to 6 hours
User performance of blood glucose monitoring systems indicated by patient [questionnaire]
Time frame: up to 4 hours
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 23 Dec 2014.
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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.
Nina Jendrike, Dr. med. principal investigator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
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 system (Omnitest 3), Blood glucose monitoring system (Omnitest 5) and Blood glucose monitoring system (Omnitest 5D) in people with Diabetes, run by B. Braun Melsungen AG 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 3 inclusion and 8 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 23 Dec 2014. 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?
System accuracy, results obtained from fingertip using blood glucose monitoring systems compared to a reference equipment (time frame: up to 6 hours). 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 23 Dec 2014.