Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus [Following EN ISO 15197:2003 - 7.3 System Accuracy Evaluation] Part 40 of Study IDT-2010

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01729546

Enrollment

114

Registered

2012-11-20

Start date

2012-11-30

Completion date

2012-11-30

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

SMBG (self-monitoring of blood glucose), POCT, System Accuracy

Brief summary

In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.

Interventions

DEVICE7 Blood glucose monitoring systems

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years of age or older * People with diabetes Typ 1 or Typ 2 and people without diabetes * for BG adjustment people with diabetes Typ 1 or Typ 2 * informed consent

Exclusion criteria

* pregnancy or lactation period * severe acute diseases * severe chronic diseases

Design outcomes

Primary

Measure	Time frame
Evaluation of System Accuracy according to ISO 15197	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026