Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany

Diabetes Clinical Trial

— IDT-1206-BA  

Official title:

Analytical Performance Evaluation of Blood Glucose Monitoring Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789021
• Other study ID #: IDT-1206-BA
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: June 17, 2015
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Male or female subjects with type 1 or type 2 diabetes or healthy subjects

• For BG adjustment people with type 1 diabetes

Exclusion Criteria:

• Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient

• Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient

• Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study

• For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness

• Legal incompetence or limited legal competence

• Age < 18 years

• Dependency from the sponsor or the clinical investigator

• Mental incapacity or language barriers precluding adequate compliance with the study procedures

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• 4 blood glucose monitoring systems

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Högel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diab — View Citation

Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value		For each subject, the experimental phase has an expected duration of up to 6 hours