NCT05091736

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

October 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

24 days

First QC Date

October 13, 2021

Last Update Submit

December 2, 2021

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Subject glucometer measurement

EXPERIMENTAL
Diagnostic Test: blood glucose measurement, blood glucose monitor for personal useDiagnostic Test: blood glucose measurement, laboratory reference device

Interventions

blood glucose measurement, blood glucose monitor for personal useDIAGNOSTIC_TEST

measurement of the blood glucose concentration using the blood glucose monitor for personal use (BG-709b)

Subject glucometer measurement
blood glucose measurement, laboratory reference deviceDIAGNOSTIC_TEST

measurement of the blood glucose concentration using a laboratory reference device

Subject glucometer measurement

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eckhard Salzsieder, PhD

    Institut fur Diabetes Karlsburg GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Eckhard Salzsieder, Director

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 25, 2021

Study Start

October 18, 2021

Primary Completion

November 11, 2021

Study Completion

November 26, 2021

Last Updated

December 3, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)