System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

NCT05195567 | Completed

• 1 other identifier: IDK_ISO_2021_007
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

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

  Day 1

Study Arms (1)

Subject glucometer measurement

EXPERIMENTAL

Diagnostic Test: Glucometer Test; Diagnostic Test: blood glucose measurement, laboratory reference device

Interventions

Glucometer Test DIAGNOSTIC_TEST

measurement of the blood glucose concentration using the blood glucose monitor for personal use

Subject glucometer measurement

blood glucose measurement, laboratory reference device DIAGNOSTIC_TEST

measurement of the blood glucose concentration using a laboratory reference device

Subject glucometer measurement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Institut fur Diabetes Karlsburg GmbH: lead
• Beurer GmbH: collaborator

Study Sites (1)

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: Dr. Eckhard Salzsieder, Director

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: February 17, 2022
• Primary Completion: March 9, 2022
• Study Completion: March 18, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)