Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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.
At the study visit, Day 1, immediate analysis upon sample collection

Interventions

BGMS AriaDevice

Diagnostic use of the blood glucose monitoring system for analytical accuracy testing.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

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.

You may qualify if:

Sponsors & Collaborators

Institut fur Diabetes Karlsburg GmbH
Otherlead

Study Sites (1)

Institut für Diabetes Karlsburg GmbH

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Eckhard Salzsieder, PhD
Institut fur Diabetes Karlsburg GmbH
STUDY DIRECTOR

Enrollment

105 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 5, 2026

Study Start

September 15, 2026

Actual (reported)

System Accuracy of the Blood Glucose Monitor for Personal Use Aria

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations