System Accuracy of 12 Bloog Glucose Monitoring Systems
Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
1 other identifier
interventional
700
1 country
1
Brief Summary
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 8, 2023
September 1, 2023
12 months
December 17, 2021
September 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement performance: System accuracy
Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment
4-6 hours
Study Arms (1)
Subject BGMS measurement
EXPERIMENTALBlood glucose measurement using BGMS
Interventions
measurement of blood glucose concentration using different BGM
measurement of blood glucose concentration using reference Method
Eligibility Criteria
You may qualify if:
- Male or female, with clinical indication for blood glucose measurement
- Signed informed consent form
- Minimum age of 18 years
- Subjects are legally competent and capable to understand character, meaning and consequences of the study.
You may not qualify if:
- Pregnancy or lactation period
- Severe acute disease (at the study physician's discretion)
- Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
- Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
- A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
- Being unable to give informed consent
- \< 18 years
- Legally incompetent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut fur Diabetes Karlsburg GmbHlead
- Aktivmed GmbHcollaborator
- Beurer GmbHcollaborator
- IME-DC GmbHcollaborator
- Medisana GmbHcollaborator
Study Sites (1)
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, 17495, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eckhard Salzsieder, PhD
Institut fur Diabetes Karlsburg GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, PhD
Study Record Dates
First Submitted
December 17, 2021
First Posted
February 2, 2022
Study Start
January 3, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
September 8, 2023
Record last verified: 2023-09