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

NCT01789021 | Completed

• 1 other identifier: IDT-1206-BA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Keywords

blood glucose monitoring systems; ISO 15197; system accuracy

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

4 blood glucose monitoring systems DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm: lead
• Bayer: collaborator

Study Sites (1)

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

Ulm, 89081, Germany

Location

Related Publications (2)

• 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 Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161.

  PMID: 25872967 RESULT

• Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Hogel 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. Diabetes Technol Ther. 2015 Sep;17(9):625-34. doi: 10.1089/dia.2015.0043. Epub 2015 May 19.

  PMID: 26062008 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 18, 2015

Record last verified: 2013-05

Locations

DE (1)