User Evaluation of BGM JS200B

• Sponsor: Institut fur Diabetes Karlsburg GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT06037538
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 89.5

Study Details

Study Description

Brief Summary

Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015

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

Study Design

• Study Type: Interventional
• Actual 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 JS200B Der Firma TysonBio gemäß DIN EN ISO 15197:2015
• Actual Study Start Date: Apr 19, 2023
• Actual Primary Completion Date: May 10, 2023
• Actual Study Completion Date: May 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subject glucometer measurement Blood glucose measurement BGM for personal use	Diagnostic Test: blood glucose measurement by subject; blood glucose measurement by subject using finger tip capillary blood; Diagnostic Test: blood glucose measurement with reference; blood glucose measurement with reference method using finger tip capillary blood

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

Investigators

• Study Director: Eckhard Salzsieder, 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: NCT06037538
• Other Study ID Numbers: 2023_003
• 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