User Evaluation of BGM JS200B | NCT06037538

Studies
User Evaluation of BGM JS200B

NCT06037538

Sponsor

Institut fur Diabetes Karlsburg GmbH

Status

Completed

Last Update Posted

Sep 14, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

blood glucose measurement by subject
blood glucose measurement with reference

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

Apr 19, 2023Actual

Primary Completion Date

May 10, 2023Actual

Completion Date

May 23, 2023Actual

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

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 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subject glucometer measurement	Experimental	Blood glucose measurement BGM for personal use	Diagnostic Test: blood glucose measurement by subject Diagnostic Test: blood glucose measurement with reference

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood glucose measurement by subject	Diagnostic Test	blood glucose measurement by subject using finger tip capillary blood	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	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male or female patients with hypo-, eu- or hyperglycaemia
The written informed consent had to be signed
The volunteers must be older than 18 years
The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

Pregnancy or lactation
Acute or chronic diseases with the risk of aggravation by the measure
A current constitution that does not allow participating in the study
Participation in another study or activity with the blood glucose measuring system evaluated in the present study
Application of substances listed in Appendix A of DIN EN ISO 15197:2015

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

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