System Accuracy Evaluation of 6 CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

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

Status: Completed

Conditions: Diabetes

Treatments: Device: 6 blood glucose monitoring systems for self-testing (blood glucose meters)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02531386

IDT-1525-BL

Details and patient eligibility

About

The objective of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. In this study, system accuracy evaluation will be performed with CE-marked BGMS (BGMS = Blood Glucose Monitoring System) common among insulin pump users - Accu-Chek Aviva Nano and Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan) Contour Next Link 2.4 (Bayer Healthcare Diabetes Care) and Accu-Chek Mobile with three different reagent system lots for each BGMS.

The study will be performed in 2 parts. Each part will comprise testing of 3 BGMS.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, with type 1 diabetes, type 2 diabetes or no diabetes

• For provoked blood glucose excursions due to insulin dose adjustment:

  • Male or female with type 1 diabetes or
  • Type 2 diabetes and intensified insulin therapy or insulin pump therapy.

• Minimum age of 18 years

• Signed informed consent form

• Legally competent and capable to understand character, meaning and consequences of the study

Exclusion criteria

• Pregnancy or lactation period
• Severe acute disease (at the study physician's discretion)
• Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
• Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
• Incapability of giving informed consent
• < 18 years
• Legally incompetent
• Accommodated in an institution (e.g. psychiatric clinic)
• Language barriers potentially compromising an adequate compliance with study procedures
• Dependent from investigator or sponsor
• For provoked blood glucose excursions 50 - 80 mg/dl (concentration category 2):
• Coronary heart disease
• Condition after myocardial infarction
• Cerebral incidence
• Peripheral arterial occlusive disease
• Hypoglycemia unawareness