System Accuracy of the Blood Glucose Monitor for Personal Use BG-709b

• Sponsor: Institut fur Diabetes Karlsburg GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT05091736
• Collaborator: Hangzhou Sejoy Electronics & Instrument Co., ltd. Joytech Healthcare Co., ltd., PRC (Other)
• Enrollment: 120
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 93.7

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: blood glucose measurement, blood glucose monitor for personal use; Diagnostic Test: blood glucose measurement, laboratory reference device	N/A

Detailed Description

This study assesses the system accuracy the blood glucose monitoring systems for personal use BG-709b as outlined in DIN EN ISO 15197:2015.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluierung Der Systemgenauigkeit Des BG-709b Blood Glucose Monitoring Systems Der Firma Sejoy gemäß DIN EN ISO 15197:2015
• Actual Study Start Date: Oct 18, 2021
• Actual Primary Completion Date: Nov 11, 2021
• Actual Study Completion Date: Nov 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subject glucometer measurement	Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use; measurement of the blood glucose concentration using the blood glucose monitor for personal use (BG-709b); Diagnostic Test: blood glucose measurement, laboratory reference device; measurement of the blood glucose concentration using a laboratory reference device

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 based on procedures defined in DIN EN ISO 15197

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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
• Hangzhou Sejoy Electronics & Instrument Co., ltd. Joytech Healthcare Co., ltd., PRC

Investigators

• Study Director: Eckhard Salzsieder, PhD, Institut fur Diabetes Karlsburg GmbH

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: NCT05091736
• Other Study ID Numbers: IDK_ISO_2021_003
• First Posted: Oct 25, 2021
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• 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 Dec 3, 2021