DiabetesNCT07859501
System Accuracy of the Blood Glucose Monitor for Personal Use Aria
An observational study of Diabetes, run by Institut fur Diabetes Karlsburg GmbH at 1 site in Germany.
Trial summary
This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- BGMS Aria
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2026to 29 Sep 2026
- Phase
- Observational
- 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
Study population: Study population comprises male and female adults with Type 1 or Type 2 diabetes mellitus, enrolled to provide capillary blood samples. In accordance with ISO 15197:2015, subject selection is non-stratified by demographic parameters. Enrollment proceeds sequentially until the required sample distribution across all specified glucose concentration bins (< 50mg/dL - > 400mg/dL) is satisfied.
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
Greifswald, Mecklenburg-Vorpommern, 17489
About this study
Official title: Evaluierung Der Systemgenauigkeit Des Blutglukose Monitoring Systems Aria Der Biochemical Systems International S.p.A. gemäß DIN EN ISO 15197:2015
This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015
- Conditions
- Diabetes
- Being tested
- BGMS Aria
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGMS AriaDevice
Diagnostic use of the blood glucose monitoring system for analytical accuracy testing.
What is being measured
The primary outcome is the main question the study is designed to answer.
System Accuracy of the Blood Glucose Monitoring System in accordance with ISO 15197:2015
Percentage of blood glucose results obtained with the test device that fall within ±15 mg/dL (±0.83 mmol/L) of the manufacturer's reference measurement procedure (Roche Cobas c111) at blood glucose concentrations < 100 mg/dL (< 5.55 mmol/L), and within ±15% at blood glucose concentrations ≥ 100 mg/dL (≥ 5.55 mmol/L), according to DIN EN ISO 15197:2015 criteria.
Measured: At the study visit, Day 1, immediate analysis upon sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start15 Sep 2026
- Primary completion24 Sep 2026
- Study completion29 Sep 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbH
- Sponsor type
- University, hospital or other
- 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
- NCT07859501
- Sponsor's protocol ID
- 2026_002_ISO
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluierung Der Systemgenauigkeit Des Blutglukose Monitoring Systems Aria Der Biochemical Systems International S.p.A. gemäß DIN EN ISO 15197:2015
- ClinicalTrials.gov ID
- NCT07859501
- Acronym / sponsor ID
- 2026_002_ISO
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Institut fur Diabetes Karlsburg GmbHUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 5 Oct 2026 (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.
This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population comprises male and female adults with Type 1 or Type 2 diabetes mellitus, enrolled to provide capillary blood samples. In accordance with ISO 15197:2015, subject selection is non-stratified by demographic parameters. Enrollment proceeds sequentially until the required sample distribution across all specified glucose concentration bins (< 50mg/dL - > 400mg/dL) is satisfied.
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 |
|---|---|---|
| BGMS AriaDiagnostic use of the blood glucose monitoring system for analytical accuracy testing. | Device | – |
Primary outcome
System Accuracy of the Blood Glucose Monitoring System in accordance with ISO 15197:2015
Time frame: At the study visit, Day 1, immediate analysis upon sample collection
Percentage of blood glucose results obtained with the test device that fall within ±15 mg/dL (±0.83 mmol/L) of the manufacturer's reference measurement procedure (Roche Cobas c111) at blood glucose concentrations < 100 mg/dL (< 5.55 mmol/L), and within ±15% at blood glucose concentrations ≥ 100 mg/dL (≥ 5.55 mmol/L), according to DIN EN ISO 15197:2015 criteria.
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 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of 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 8 Oct 2026. 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 of the Blood Glucose Monitoring System in accordance with ISO 15197:2015 (time frame: At the study visit, Day 1, immediate analysis upon sample collection). 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 Oct 2026.