System Accuracy of the Blood Glucose Monitor for Personal Use BG-709b
NCT05091736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-12-03
Summary
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Hangzhou Sejoy Electronics & Instrument Co., ltd. Joytech Healthcare Co., ltd., PRC
collaborator UNKNOWN -
Institut fur Diabetes Karlsburg GmbH
lead OTHER
Principal Investigators
-
Eckhard Salzsieder, PhD · Institut fur Diabetes Karlsburg GmbH
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-18
- Primary Completion
- 2021-11-11
- Completion
- 2021-11-26
Countries
- Germany
Study Locations
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