DiabetesNCT06037512
User Evaluation of BGM VGM77
A study testing subject and reference in people with Diabetes, run by Institut fur Diabetes Karlsburg GmbH at 1 site in Germany.
Trial summary
Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015 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?
- subject and reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 13 Apr 2023to 15 Jun 2023
- 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 patients with hypo-, eu- or hyperglycaemia
- The written informed consent had to be signed
- The volunteers must be older than 18 years
- The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
Who cannot join
- Pregnancy or lactation
- Acute or chronic diseases with the risk of aggravation by the measure
- A current constitution that does not allow participating in the study
- Participation in another study or activity with the blood glucose measuring system evaluated in the present study
- Application of substances listed in Appendix A of DIN EN ISO 15197:2015
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: Evaluierung Des Blutglukose Monitoring Systems VGM77 Der Firma Beurer GmbH gemäß DIN EN ISO 15197:2015
Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015
- Conditions
- Diabetes
- Being tested
- subject, reference
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjectDiagnostic test
blood glucose measurement by subject
referenceDiagnostic test
blood glucose measurement with reference
| Study group | Role | What they receive |
|---|---|---|
| Subject glucometer measurement | Experimental | Blood glucose measurement BGM for personal use Receives: Diagnostic Test: subject; Diagnostic Test: reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of system accuracy based on DIN EN ISO 15197
Assessment of the analytical measurement performance of the blood glucose monitor
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start13 Apr 2023
- Primary completion6 Jun 2023
- Study completion15 Jun 2023
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eckhard Salzsieder, PhD, Study director, Institut fur Diabetes Karlsburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037512
- Sponsor's protocol ID
- 2023_002
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluierung Des Blutglukose Monitoring Systems VGM77 Der Firma Beurer GmbH gemäß DIN EN ISO 15197:2015
- ClinicalTrials.gov ID
- NCT06037512
- Acronym / sponsor ID
- 2023_002
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbHUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 14 Sep 2023 (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.
Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject glucometer measurement | Experimental | Diagnostic Test: subject, Diagnostic Test: referenceBlood glucose measurement BGM for personal use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients with hypo-, eu- or hyperglycaemia
- The written informed consent had to be signed
- The volunteers must be older than 18 years
- The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Acute or chronic diseases with the risk of aggravation by the measure
- A current constitution that does not allow participating in the study
- Participation in another study or activity with the blood glucose measuring system evaluated in the present study
- Application of substances listed in Appendix A of DIN EN ISO 15197:2015
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 |
|---|---|---|
| subjectblood glucose measurement by subject | Diagnostic test | Subject glucometer measurement |
| referenceblood glucose measurement with reference | Diagnostic test | Subject glucometer measurement |
Primary outcome
Analysis of system accuracy based on DIN EN ISO 15197
Time frame: 1 Day
Assessment of the analytical measurement performance of the blood glucose monitor
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 14 Sep 2023.
- Individual participant dataSharing planned: No
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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 subject and reference in people with Diabetes, 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 5 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 14 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?
Analysis of system accuracy based on DIN EN ISO 15197 (time frame: 1 Day). 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 14 Sep 2023.