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CompletedNCT05124834Updated Feb 9, 2022

System Accuracy of the Blood Glucose Monitor for Personal Use JT100

An interventional study of blood glucose measurement, blood glucose monitor for personal use and blood glucose measurement, laboratory reference device in Diabetes Mellitus, sponsored by Institut fur Diabetes Karlsburg GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Read the detailed description

This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

02

Conditions studied

  • Diabetes Mellitus
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
Yes

Inclusion criteria

  • Male or female patients with clinical indication for blood glucose testing
  • Signed form of consent
  • Minimum age of 18 years
  • Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or lactation
  • Severe acute disease (at study physician's discretion)
  • Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
  • Current constitution that does not allow participating in the study (e.g. hematocrit out of
  • the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
  • Being unable to give informed consent
  • Age younger than 18 years
  • Legally incompetent
05

Study design

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

Study arms

  • Experimental
    Subject glucometer measurement

    Blood glucose measurement BGM for personal use

    Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use · Diagnostic Test: blood glucose measurement, laboratory reference device

Interventions

  • Diagnostic testblood glucose measurement, blood glucose monitor for personal use

    measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)

    Also known as: measurement of the blood glucose concentration using the blood glucose monitor for personal use (TJ100)

  • Diagnostic testblood glucose measurement, laboratory reference device

    measurement of the blood glucose concentration using a laboratory reference device (YSI 2300 Stat Plus)

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: day 1

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: No

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 Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05124834
Lead sponsor
Institut fur Diabetes Karlsburg GmbH
Collaborators
Tyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
Responsible party
Matthes Kenning (Dr. Eckhard Salzsieder, Director, Institut fur Diabetes Karlsburg GmbH) — Principal investigator
First posted
Nov 18, 2021
Start date
Jan 15, 2022
Primary completion
Feb 4, 2022
Completion
Feb 4, 2022
Last update
Feb 9, 2022

Study contacts

Eckhard Salzsieder, PhD
study director · Institut fur Diabetes Karlsburg GmbH

Oversight

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 Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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