Diabetes MellitusNCT05219526
System Accuracy of 12 Bloog Glucose Monitoring Systems
A study testing blood glucose measurement: BGM and blood glucose measurement: reference method in people with Diabetes Mellitus, run by Institut fur Diabetes Karlsburg GmbH at 1 site in Germany.
Trial summary
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- blood glucose measurement: BGM and blood glucose measurement: reference method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jan 2022to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, with clinical indication for blood glucose measurement
- Signed informed consent form
- Minimum age of 18 years
- Subjects are 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 inherent risk of aggravation by the procedure (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)
- A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
- Being unable to give informed consent
- < 18 years
- Legally incompetent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, 17495
About this study
Official title: Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.
- Conditions
- Diabetes Mellitus
- Being tested
- blood glucose measurement: BGM, blood glucose measurement: reference method
- 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 measurement: BGMDiagnostic test
measurement of blood glucose concentration using different BGM
blood glucose measurement: reference methodDiagnostic test
measurement of blood glucose concentration using reference Method
| Study group | Role | What they receive |
|---|---|---|
| Subject BGMS measurement | Experimental | Blood glucose measurement using BGMS Receives: Diagnostic Test: blood glucose measurement: BGM; Diagnostic Test: blood glucose measurement: reference method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement performance: System accuracy
Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment
Measured: 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start3 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Aktivmed GmbH, Beurer GmbH, IME-DC GmbH, Medisana GmbH
- Responsible party
- Principal investigator, Matthes Kenning, Institut fur Diabetes Karlsburg GmbH
- Investigators
- Eckhard Salzsieder, PhD, Study director, Institut fur Diabetes Karlsburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219526
- Sponsor's protocol ID
- IDK_2021_006
- Status last verified
- Sep 2023
- First submitted
- 17 Dec 2021
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
- ClinicalTrials.gov ID
- NCT05219526
- Acronym / sponsor ID
- IDK_2021_006
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbHUniversity, hospital or other
- Collaborators
- Aktivmed GmbH, Beurer GmbH, IME-DC GmbH, Medisana GmbH
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Feb 2022 (actual)
- 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 system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject BGMS measurement | Experimental | Diagnostic Test: blood glucose measurement: BGM, Diagnostic Test: blood glucose measurement: reference methodBlood glucose measurement using BGMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, with clinical indication for blood glucose measurement
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
Key exclusion criteria (8 listed)
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with inherent risk of aggravation by the procedure (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)
- A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
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 measurement: BGMmeasurement of blood glucose concentration using different BGM | Diagnostic test | Subject BGMS measurement |
| blood glucose measurement: reference methodmeasurement of blood glucose concentration using reference Method | Diagnostic test | Subject BGMS measurement |
Primary outcome
Measurement performance: System accuracy
Time frame: 4-6 hours
Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment
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 8 Sep 2023.
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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.
Eckhard Salzsieder, PhD study director
Institut fur Diabetes Karlsburg GmbH
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 measurement: BGM and blood glucose measurement: reference method in people with Diabetes Mellitus, run by Institut fur Diabetes Karlsburg GmbH 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 4 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 8 Sep 2023. 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?
Measurement performance: System accuracy (time frame: 4-6 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 8 Sep 2023.