Assessment of Blood Glucose Monitoring Systems

Diabetes Clinical Trial

Official title:

Leistungsbewertung Von Blutzuckermesssystemen im Methodenvergleich

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909687
• Other study ID #: IDT-1313-SF
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: June 26, 2015
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Design

N/A

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Blood glucose monitoring systems

Locations

Country	Name	City	State
Germany	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft an der Universität Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm	Sanofi

Country where clinical trial is conducted

Germany, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of system accuracy		for each subject, the experimental phase has an expected duration of up to 6 hours