System Accuracy of 14 Blood Glucose Monitoring Systems

• Sponsor: Institut fur Diabetes Karlsburg GmbH (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06037499
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 20.9

Study Details

Study Description

Brief Summary

The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Diagnostic Test: Glucometer Test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Leistungsbewertungsprüfung Der Systemgenauigkeit, Von 14 Blutglukose Monitoring Systemen in Anlehnung an ISO 15197:2015
• Actual Study Start Date: Mar 3, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subject glucometer measurement	Diagnostic Test: Glucometer Test; measurement of blood glucose concentration using different BGM and Reference Method

Outcome Measures

Primary Outcome Measures

1. Blood glucose measurement using BGMS [Day 1]

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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut fur Diabetes Karlsburg GmbH
• ClinicalTrials.gov Identifier: NCT06037499
• Other Study ID Numbers: 2023_001
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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