Blood Glucose Monitoring Systems: Discounter Versus Brand
Cheap Equals Bad? Comparative System Accuracy of POCT Blood Glucose Monitoring Systems Under the Aspect of Aspect of Pricing: Discounter Versus Brand
1 other identifier
interventional
122
1 country
1
Brief Summary
This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Sep 2021
Shorter than P25 for not_applicable diabetes-mellitus
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
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
September 1, 2021
CompletedStudy Start
First participant enrolled
September 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2021
CompletedOctober 14, 2021
August 1, 2021
1 month
August 19, 2021
October 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Analysis of system accuracy based on DIN EN ISO 15197
Assessment of the analytical measurement performance of 5 blood glucose montoring systems based on procedures defined in DIN EN ISO 15197
day 1
Study Arms (1)
Subject POCT glucometer measurement
EXPERIMENTALBlood glucose measurement POCT glucometer
Interventions
measurement of blood glucose concentration using 5 different POCT glucometer
measurement of blood glucose concentration using 2 different laboratory analyzer
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
Study Sites (1)
Institut für Diabetes Karlsburg GmbH
Karlsburg, Mecklenburg-Vorpommern, 17495, Germany
Related Links
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
- SPONSOR
Study Record Dates
First Submitted
August 19, 2021
First Posted
September 1, 2021
Study Start
September 3, 2021
Primary Completion
October 6, 2021
Study Completion
October 6, 2021
Last Updated
October 14, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share