NCT06037551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable diabetes

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

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

September 7, 2023

Last Update Submit

April 14, 2025

Conditions

Diabetes

Outcome Measures

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

    1 Day

Study Arms (2)

Subject glucometer measurement

EXPERIMENTAL

Blood glucose measurement BGM for personal use

Diagnostic Test: blood glucose measuremen subjectDiagnostic Test: blood glucose measuremen reference

glucometer measurement

EXPERIMENTAL

evaluation of repeatability measurement precision

Diagnostic Test: blood glucose measuremen reference

Interventions

blood glucose measuremen subjectDIAGNOSTIC_TEST

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

Subject glucometer measurement
blood glucose measuremen referenceDIAGNOSTIC_TEST

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

Subject glucometer measurementglucometer measurement

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

  • Kerstin Rebrin, PhD

    Institut fur Diabetes Karlsburg GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 30, 2023

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

DE(1)