- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037499
System Accuracy of 14 Blood Glucose Monitoring Systems
September 7, 2023 updated by: Institut fur Diabetes Karlsburg GmbH
Leistungsbewertungsprüfung Der Systemgenauigkeit, Von 14 Blutglukose Monitoring Systemen in Anlehnung an ISO 15197:2015
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
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
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
|
measurement of blood glucose concentration using different BGM and Reference Method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood glucose measurement using BGMS
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 3, 2023
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
September 7, 2023
First Submitted That Met QC Criteria
September 7, 2023
First Posted (Actual)
September 14, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2023_001
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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