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CompletedNCT01789021IDT-1206-BAUpdated Jun 18, 2015

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

An interventional study of 4 blood glucose monitoring systems in Diabetes, sponsored by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

Keywords

  • blood glucose monitoring systems
  • ISO 15197
  • system accuracy
03

In context

Lead sponsor

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Enrollment
120 participants (estimated)

Interventions

  • Device4 blood glucose monitoring systems
06

What researchers measure

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

    Time frame: For each subject, the experimental phase has an expected duration of up to 6 hours

07

Study locations

1 site
  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
    Ulm, 89081, Germany
08

References and documents

Publications

  • 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. PubMed 25872967 ↗
  • 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. PubMed 26062008 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01789021
Lead sponsor
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Collaborators
Bayer
Responsible party
Sponsor
First posted
Feb 11, 2013
Start date
Feb 2013
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jun 18, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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