System Accuracy Evaluation of 2 CE-marked Blood Glucose Monitoring System

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.

However in this study, system accuracy evaluation will be performed for Hemocue Glucose 201+ and Hemocue Glucose 201 RT which are both glucose monitoring systems for professional use only on behalf of the IDT with one reagent system lot for each BGMS.

Main goal is the evaluation of system accuracy of both of the hemocue Systems. (english)

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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 subjects without diabetes
Signed informed consent form
Minimum age of 18 years
Subjects are legally competent and capable to understand character, meaning and consequences of the study.
If blood glucose values < 80 mg/dl or > 300 mg/dl shall be measured after short term alteration in insulin therapy:
Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
Signature of subjects to document consent with these procedures on informed consent form.

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)
Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
Being unable to give informed consent
< 18 years
Legally incompetent
Being committed to an institution (e.g. psychiatric clinic)
Language barriers potentially compromising an adequate compliance with study procedures
Dependent on investigator or sponsor
If blood glucose values < 80 mg/dl shall be measured after short term alteration in insulin therapy (concentration category 2, see Fehler! Verweisquelle konnte nicht gefunden werden.), subjects with type 1 diabetes, suffering from:
Coronary heart disease
Condition after myocardial infarction
Condition after cerebral events
Peripheral arterial occlusive disease
Hypoglycemia unawareness

Treatment and study plan

Blood glucose monitoring systems for point-of-care-testing

Device

Other names: Hemocue Glucose 201+ and Hemocue Glucose 201 RT

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 17, 2016
Registry last updated: Aug 31, 2016

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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