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NCT Number: NCT02531386

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Other names: Accu-Chek Aviva Nano, Accu-Chek Performa Nano, FreeStyle Lite, OneTouch Verio IQ, Contour Next Link 2.4, Accu-Chek Mobile

Primary outcomes

  1. System accuracy criteria (see description)

    Time frame: For each subject, the experimental phase has an expected duration of up to 6 hours

    System accuracy criteria

    Following ISO 15197:2013 (E), the BGMS shall meet both of the following criteria:

    Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).

    Each lot shall pass acceptability criterion A.

    Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.

    Applying ISO 15197:2003 accuracy criteria:

    95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Bayer

Registry information

Official study title

System Accuracy Evaluation of Accu-Chek Aviva Nano (Roche Diagnostics), Accu-Chek Performa Nano (Roche Diagnostics), FreeStyle Lite (Abbott Diabetes Care), OneTouch Verio IQ (LifeScan), Contour Next Link 2.4 (Bayer Consumer Care), One Additional CE-marked Blood Glucose Monitoring System Following ISO 15197:2013

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2015
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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