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CompletedNCT06037551Updated Apr 17, 2025

System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

An interventional study of blood glucose measuremen subject and blood glucose measuremen reference in Diabetes, sponsored by Institut fur Diabetes Karlsburg GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Institut fur Diabetes Karlsburg GmbH · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study assesses the system accuracy of a blood glucose monitoring system in accordance with DIN EN ISO 15197:2015

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

Institut fur Diabetes Karlsburg GmbH is the lead sponsor of 15 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
No

Inclusion criteria

  • Male or female patients with hypo-, eu- or hyperglycaemia
  • The written informed consent had to be signed
  • The volunteers must be older than 18 years
  • The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria

Exclusion criteria:

  • Pregnancy or lactation
  • Acute or chronic diseases with the risk of aggravation by the measure
  • A current constitution that does not allow participating in the study
  • Participation in another study or activity with the blood glucose measuring system evaluated in the present study
  • Application of substances listed in Appendix A of DIN EN ISO 15197:2015
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Subject glucometer measurement

    Blood glucose measurement BGM for personal use

    Diagnostic Test: blood glucose measuremen subject · Diagnostic Test: blood glucose measuremen reference

  • Experimental
    glucometer measurement

    evaluation of repeatability measurement precision

    Diagnostic Test: blood glucose measuremen reference

Interventions

  • Diagnostic testblood glucose measuremen subject

    measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood

  • Diagnostic testblood glucose measuremen reference

    measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood

06

What researchers measure

Primary outcomes

  1. Analysis of system accuracy based on DIN EN ISO 15197

    Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197

    Time frame: 1 Day

07

Study locations

1 site
  • Institut für Diabetes Karlsburg GmbH
    Karlsburg, Mecklenburg Vorpommern 17495, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — optional: age, blood glucose levels and hematocrit of subjects

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06037551
Lead sponsor
Institut fur Diabetes Karlsburg GmbH
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Oct 1, 2023
Primary completion
Nov 1, 2023
Completion
Nov 30, 2023
Last update
Apr 17, 2025

Study contacts

Kerstin Rebrin, PhD
study director · Institut fur Diabetes Karlsburg GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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