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Assessment of Blood Glucose Monitoring Systems

I

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

Status

Completed

Conditions

Diabetes

Treatments

Device: Blood glucose monitoring systems

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01909687
IDT-1313-SF

Details and patient eligibility

About

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

Enrollment

163 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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