NCT01729546

Brief Summary

In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
Last Updated

January 14, 2015

Status Verified

November 1, 2012

Enrollment Period

Same day

First QC Date

November 14, 2012

Last Update Submit

January 13, 2015

Conditions

Diabetes

Keywords

SMBG (self-monitoring of blood glucose)POCTSystem Accuracy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of System Accuracy according to ISO 15197

Interventions

7 Blood glucose monitoring systemsDEVICE

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • People with diabetes Typ 1 or Typ 2 and people without diabetes
  • for BG adjustment people with diabetes Typ 1 or Typ 2
  • informed consent

You may not qualify if:

  • pregnancy or lactation period
  • severe acute diseases
  • severe chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Freckmann G, Schmid C, Pleus S, Baumstark A, Link M, Stolberg E, Haug C, Sieber J. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems. Clin Chem Lab Med. 2014 Jul;52(7):1079-86. doi: 10.1515/cclm-2013-0976.

    PMID: 24681433RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 14, 2015

Record last verified: 2012-11

Locations

DE(1)