NCT01909687

Brief Summary

System accuracy evaluation of different blood glucose monitoring systems with 3 lots of test strips per systems according to ISO 15197:2013

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable diabetes

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

July 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 29, 2015

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

July 2, 2013

Last Update Submit

June 26, 2015

Conditions

Diabetes

Keywords

blood glucose monitoring systemsISO 15197system accuracy

Outcome Measures

Primary Outcomes (1)

  • Analysis of system accuracy

    for each subject, the experimental phase has an expected duration of up to 6 hours

Interventions

Blood glucose monitoring systemsDEVICE
Also known as: Accu-Chek Aviva, Contour XT, FreeStyle Insulinx, Accu-Chek Performa, Contour next USB, BGStar, OneTouch Verio IQ, MyStar Extra, mylife Pura, Glucocard G+

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Male or female subjects with type 1 or type 2 diabetes or healthy subjects
  • For BG adjustment people with type 1 diabetes

You may not qualify if:

  • Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
  • Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
  • Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
  • For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
  • Legal incompetence or limited legal competence
  • Age \< 18 years
  • Dependency from the sponsor or the clinical investigator
  • Mental incapacity or language barriers precluding adequate compliance with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ulm, 89081, Germany

Location

Related Publications (1)

  • Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods. Diabetes Technol Ther. 2015 Sep;17(9):635-48. doi: 10.1089/dia.2015.0085. Epub 2015 Jun 25.

    PMID: 26110670RESULT

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

July 2, 2013

First Posted

July 26, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 29, 2015

Record last verified: 2013-12

Locations

DE(1)