System Accuracy of a Blood Glucose Monitoring System Gluc... | NCT05195567

Studies
System Accuracy of a Blood Glucose Monitoring System GlucoSpark/GlucoScore

NCT05195567

Sponsor

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Last Update Posted

Apr 4, 2022Actual

Enrollment

103Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Glucometer Test
blood glucose measurement, laboratory reference device

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2022Actual

Primary Completion Date

Mar 9, 2022Actual

Completion Date

Mar 18, 2022Actual

First Submitted Date

Jan 4, 2022

First Submission Date that Met QC Criteria

Jan 17, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2022

Last Update Posted Date

Apr 4, 2022Actual

Name	Class
Beurer GmbH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subject glucometer measurement	Experimental		Diagnostic Test: Glucometer Test Diagnostic Test: blood glucose measurement, laboratory reference device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucometer Test	Diagnostic Test	measurement of the blood glucose concentration using the blood glucose monitor for personal use	Subject glucometer measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of system accuracy based on DIN EN ISO 15197	Assessment of the analytical measurement performance of the blood glucose monitor based on procedures defined in DIN EN ISO 15197	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eckhard Salzsieder, PhD	Institut fur Diabetes Karlsburg GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut für Diabetes Karlsburg GmbH		Karlsburg	Mecklenburg-Vorpommern	17495	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided