System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

• Sponsor: Institut fur Diabetes Karlsburg GmbH (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06037551
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 50.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Diagnostic Test: blood glucose measuremen subject; Diagnostic Test: blood glucose measuremen reference	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluierung Des Blutglukose Monitoring Systems Contour Care Der Firma Ascensia Diabetes Care Deutschland GmbH gemäß DIN EN ISO 15197:2015
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subject glucometer measurement Blood glucose measurement BGM for personal use	Diagnostic Test: blood glucose measuremen subject; measurement of the blood glucose concentration of subject using BGM and capillary finger tip blood; Diagnostic Test: blood glucose measuremen reference; measurement of the blood glucose concentration of subject using reference method and capillary finger tip blood

Outcome Measures

Primary Outcome Measures

1. Analysis of system accuracy based on DIN EN ISO 15197 [1 Day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut für Diabetes Karlsburg GmbH	Karlsburg	Mecklenburg Vorpommern	Germany	17495

Sponsors and Collaborators

• Institut fur Diabetes Karlsburg GmbH

Investigators

• Study Director: Kerstin Rebrin, PhD, Institut fur Diabetes Karlsburg GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut fur Diabetes Karlsburg GmbH
• ClinicalTrials.gov Identifier: NCT06037551
• Other Study ID Numbers: 2023_005
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 14, 2023