- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146933
System Accuracy of BGM GL22
November 24, 2023 updated by: Matthes Kenning, Institut fur Diabetes Karlsburg GmbH
Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.
This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
113
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mecklenburg Vorpommern
-
Karlsburg, Mecklenburg Vorpommern, Germany, 17495
- Institut für Diabetes Karlsburg GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subject glucometer measurement
|
blood glucose measurement using finger tip capillary blood using BGM
blood glucose measurement using finger tip capillary blood using reference method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of system accuracy based on DIN EN ISO 15197
Time Frame: Day 1
|
Assessment of the analytical measurement performance of the blood glucose monitor
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kerstin Rebrin, PhD, Institut für Diabetes Karlsburg GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
November 22, 2023
Study Completion (Actual)
November 24, 2023
Study Registration Dates
First Submitted
September 7, 2023
First Submitted That Met QC Criteria
November 24, 2023
First Posted (Actual)
November 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2023_004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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