System Accuracy of BGM GL60

• Sponsor: Institut fur Diabetes Karlsburg GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT06037486
• Collaborator: Beurer GmbH (Other)
• Enrollment: 101
• Location: 1
• Arm: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 106

Study Details

Study Description

Brief Summary

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

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

Detailed Description

This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL60 gemäß DIN EN ISO 15197:2015
• Actual Study Start Date: Oct 17, 2022
• Actual Primary Completion Date: Nov 3, 2022
• Actual Study Completion Date: Nov 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

   Assessment of the analytical measurement performance of the blood glucose monitor

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
• Beurer GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthes Kenning, Dr. Eckhard Salzsieder, Director, Institut fur Diabetes Karlsburg GmbH
• ClinicalTrials.gov Identifier: NCT06037486
• Other Study ID Numbers: 2022_002
• 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