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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7 Blood glucose monitoring systems

Device

Primary outcomes

Evaluation of System Accuracy according to ISO 15197

Sponsors and collaborators

Lead sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Other

Collaborators

Sanofi

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Nov 20, 2012
Registry last updated: Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed