System Accuracy of 12 Bloog Glucose Monitoring Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

System Accuracy of 14 Blood Glucose Monitoring Systems

NCT06037499

Diabetes

COMPLETED NA

System Accuracy of BGM GL60

NCT06037486

Diabetes Mellitus

COMPLETED NA

System Accuracy of BGM GL22

NCT06146933

Diabetes

COMPLETED NA

System Accuracy of the Blood Glucose Monitor for Personal Use Contour Care

NCT06037551

Diabetes

COMPLETED NA

System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

NCT05195567

Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subject BGMS measurement

Blood glucose measurement using BGMS

Group Type EXPERIMENTAL

blood glucose measurement: BGM

Intervention Type DIAGNOSTIC_TEST

measurement of blood glucose concentration using different BGM

blood glucose measurement: reference method

Intervention Type DIAGNOSTIC_TEST

measurement of blood glucose concentration using reference Method

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood glucose measurement: BGM

measurement of blood glucose concentration using different BGM

Intervention Type DIAGNOSTIC_TEST

blood glucose measurement: reference method

measurement of blood glucose concentration using reference Method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No