System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

March 22, 2022 updated by: Matthes Kenning, Institut fur Diabetes Karlsburg GmbH

Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GlucoSpark / GlucoScore gemäß DIN EN ISO 15197:2015.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg Vorpommern
      • Karlsburg, Mecklenburg Vorpommern, Germany, 17495
        • Institut für Diabetes Karlsburg GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Subject glucometer measurement
Diagnostic test: Glucometer Test
measurement of the blood glucose concentration using the blood glucose monitor for personal use
Diagnostic test: blood glucose measurement, laboratory reference device
measurement of the blood glucose concentration using a laboratory reference device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of system accuracy based on DIN EN ISO 15197
Time Frame: Day 1
Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fur Diabetes Karlsburg GmbH

Collaborators

Beurer GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 17, 2022

Primary Completion (ACTUAL)

March 9, 2022

Study Completion (ACTUAL)

March 18, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IDK_ISO_2021_007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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