System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-03-18

Brief Summary

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This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

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Detailed Description

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This study assesses the system accuracy the blood glucose monitoring systems for personal use GucoSaprk/GlucoScore as outlined in DIN EN ISO 15197:2015.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subject glucometer measurement

Group Type EXPERIMENTAL

Glucometer Test

Intervention Type DIAGNOSTIC_TEST

measurement of the blood glucose concentration using the blood glucose monitor for personal use

blood glucose measurement, laboratory reference device

Intervention Type DIAGNOSTIC_TEST

measurement of the blood glucose concentration using a laboratory reference device

Interventions

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Glucometer Test

measurement of the blood glucose concentration using the blood glucose monitor for personal use

Intervention Type DIAGNOSTIC_TEST

blood glucose measurement, laboratory reference device

measurement of the blood glucose concentration using a laboratory reference device

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* 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
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No