NCT05158478

Brief Summary

This study assesses the repeatability precision of a blood glucose monitoring system pursuant to ISO 15197

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

December 2, 2021

Last Update Submit

July 26, 2022

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • repeatability precision

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

    day 1

Study Arms (1)

Subject glucometer measurement

EXPERIMENTAL
Diagnostic Test: blood glucose measurement, blood glucose monitor for personal useDiagnostic Test: blood glucose measurement, laboratory reference device

Interventions

blood glucose measurement, blood glucose monitor for personal useDIAGNOSTIC_TEST

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)
Subject glucometer measurement
blood glucose measurement, laboratory reference deviceDIAGNOSTIC_TEST

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

Subject glucometer measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eckhard Salzsieder, PhD

    Institut fur Diabetes Karlsburg GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, PhD

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

February 22, 2022

Primary Completion

February 22, 2022

Study Completion

March 14, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

DE(1)