System Accuracy of 12 Bloog Glucose Monitoring Systems | NCT05219526

Studies
System Accuracy of 12 Bloog Glucose Monitoring Systems

NCT05219526

Sponsor

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Last Update Posted

Sep 8, 2023Actual

Enrollment

700Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

blood glucose measurement: BGM
blood glucose measurement: reference method

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

Sep 2023

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

Jan 3, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Dec 17, 2021

First Submission Date that Met QC Criteria

Jan 20, 2022

First Posted Date

Feb 2, 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

Sep 7, 2023

Last Update Posted Date

Sep 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthes Kenning, Director, PhD, Institut fur Diabetes Karlsburg GmbHPrincipal Investigator

Lead Sponsor

Institut fur Diabetes Karlsburg GmbHOTHER

Collaborators

Name	Class
Aktivmed GmbH	UNKNOWN
Beurer GmbH	UNKNOWN
IME-DC GmbH	UNKNOWN
Medisana GmbH

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

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.

Detailed Description

Not provided

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

700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subject BGMS measurement	Experimental	Blood glucose measurement using BGMS	Diagnostic Test: blood glucose measurement: BGM Diagnostic Test: blood glucose measurement: reference method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood glucose measurement: BGM	Diagnostic Test	measurement of blood glucose concentration using different BGM	Subject BGMS measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement performance: System accuracy	Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment	4-6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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

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