Diabetes MellitusNCT03033849
User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
A study testing Blood glucose monitoring system for self-testing Contour® Next One, Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect and Blood glucose monitoring system for self-testing FreeStyle Freedom Lite in people with Diabetes Mellitus, 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® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Blood glucose monitoring system for self-testing Contour® Next One, Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect and Blood glucose monitoring system for self-testing FreeStyle Freedom Lite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Mar 2017
- 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 subjects without diabetes
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
- If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
- Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
- Signature of subjects to document consent with these procedures on informed consent form.
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)
- Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Being unable to give informed consent
- < 18 years
Show all 16Show fewer
- Legally incompetent
- Being committed to an institution (e.g. psychiatric clinic)
- Language barriers potentially compromising an adequate compliance with study procedures
- Dependent on investigator or sponsor
- If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
- Coronary heart disease
- Condition after myocardial infarction
- Condition after cerebral events
- 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, Baden-Wurttemberg, 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® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.
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 Mellitus
- Being tested
- Blood glucose monitoring system for self-testing Contour® Next One, Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect, Blood glucose monitoring system for self-testing FreeStyle Freedom Lite, Blood glucose monitoring system for self-testing OneTouch® Verio, Blood glucose monitoring system for self-testing GlucoMen® areo
- 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 for self-testing Contour® Next OneDevice
Also called Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio, GlucoMen® areo
This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS).
The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.
Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.
Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.
Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.
The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.
An additional skin puncture will be performed by study personnel with single-use lancing devices.
Blood glucose monitoring system for self-testing Accu-Chek® Aviva ConnectDevice
Blood glucose monitoring system for self-testing FreeStyle Freedom LiteDevice
Blood glucose monitoring system for self-testing OneTouch® VerioDevice
Blood glucose monitoring system for self-testing GlucoMen® areoDevice
| Study group | Role | What they receive |
|---|---|---|
| Blood glucose measurement | Experimental | Every study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results. Receives: Device: Blood glucose monitoring system for self-testing Contour® Next One; Device: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect; Device: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite; Device: Blood glucose monitoring system for self-testing OneTouch® Verio; Device: Blood glucose monitoring system for self-testing GlucoMen® areo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance criteria defined by ISO 15197:2013 (E) will be applied
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 posted27 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Ascensia Diabetes Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033849
- Sponsor's protocol ID
- IDT-1608-AL
- Status last verified
- Sep 2017
- First submitted
- 16 Jan 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
Publications
Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. 2019 Feb;35(2):301-311. doi: 10.1080/03007995.2018.1491832. Epub 2018 Jul 19.
PubMed 29927663
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance Evaluation of Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio and GlucoMen® Areo Blood Glucose Monitoring Systems Following ISO 15197:2013
- ClinicalTrials.gov ID
- NCT03033849
- Acronym / sponsor ID
- IDT-1608-AL
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität UlmUniversity, hospital or other
- Collaborators
- Ascensia Diabetes Care
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Jan 2017 (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® Next One (Ascensia Diabetes Care GmbH), Accu-Chek® Aviva Connect (Roche Diabetes Care GmbH), FreeStyle Freedom Lite (Abbott Diabetes Care Inc.), OneTouch® Verio (LifeScan Europe) and GlucoMen® areo A. Menarini Diagnostics S.r.l. (based on ISO 15197:2013; EN ISO 15197:2015, clause 8.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood glucose measurement | Experimental | Device: Blood glucose monitoring system for self-testing Contour® Next One, Device: Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect, Device: Blood glucose monitoring system for self-testing FreeStyle Freedom Lite, Device: Blood glucose monitoring system for self-testing OneTouch® Verio, Device: Blood glucose monitoring system for self-testing GlucoMen® areoEvery study subject shall test three out of the five devices. The testing order of the BGMS will be changed on each subject to minimize any order effects on measurement results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
- If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
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)
- Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- Being unable to give 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 system for self-testing Contour® Next OneAlso: Contour® Next One, Accu-Chek® Aviva Connect, FreeStyle Freedom Lite, OneTouch® Verio, GlucoMen® areoThis is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS). The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel. Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter. Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method. Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter. The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented. An additional skin puncture will be performed by study personnel with single-use lancing devices. | Device | Blood glucose measurement |
| Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect | Device | Blood glucose measurement |
| Blood glucose monitoring system for self-testing FreeStyle Freedom Lite | Device | Blood glucose measurement |
| Blood glucose monitoring system for self-testing OneTouch® Verio | Device | Blood glucose measurement |
| Blood glucose monitoring system for self-testing GlucoMen® areo | Device | Blood glucose measurement |
Primary outcome
Acceptance criteria defined by ISO 15197:2013 (E) will be applied
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 12 Sep 2017.
- Derived from this study: PubMed 29927663Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. 2019 Feb;35(2):301-311. doi: 10.1080/03007995.2018.1491832. Epub 2018 Jul 19.
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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 system for self-testing Contour® Next One, Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect and Blood glucose monitoring system for self-testing FreeStyle Freedom Lite in people with Diabetes Mellitus, 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 7 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 12 Sep 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 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 (E) will be applied (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?
On the ClinicalTrials.gov record for NCT03033849, which also lists 1 linked publication.
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 12 Sep 2017.