User Performance Evaluation of Contour® Plus One, Accu-Ch... | NCT02916576

NCT02916576

Status Module

Name	Class
Ascensia Diabetes Care	INDUSTRY

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Blood glucose measurement	Experimental		Device: Blood-Glucose Monitoring Systems for self-testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood-Glucose Monitoring Systems for self-testing	Device	This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS). The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel. Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter. Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method. Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter. The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented. An additional skin puncture will be performed by study personnel with single-use lancing devices.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
System accuracy criteria (see description)	Acceptance criteria defined by ISO 15197:2013 (E) / EN ISO 15197:2015 will be applied: 95 % of the individual glucose measured values shall fall within ± 15 mg/dl (0.83 mmol/l) of the measured values of the comparison measurement procedure at glucose concentrations < 100 mg/dl (5.55 mmol/l) and within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l).	For each subject, the experimental phase has an expected duration of up to 3 hours

Eligibility Module

Eligibility Criteria

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, subjects with type 1 diabetes, suffering from:
Coronary heart disease
Condition after myocardial infarction
Condition after cerebral events
Peripheral arterial occlusive disease
Hypoglycemia unawareness

Inclusion and exclusion criteria defined by ISO 15197:2013; EN ISO 15197:2015:

Only subjects with diabetes type 1 or type 2 will be included.
Demographic data will be collected to demonstrate that subjects represent different ages, genders and education levels.
In deviation from ISO 15197:2013; EN ISO 15197:2015, included subjects may have participated in a study involving the BGMS, but must not yet have performed measurements with the BGMS according to their own statement for the last 3 years.
In addtition, included subjects did not use the BGMS being evaluated at home for the last 3 years according to their own statement.
In order to ensure that capillary blood samples meet the requirements indicated in the manufacturer's labelling,
a physician will review the subjects' anamnesis and medication and check for interfering substances indicated in the manufacturer's labelling.
the hematocrit value of each subject will be checked to be within the range indicated in the manufacturer's labelling (hematocrit determination before or after the measurement procedure).

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D012648	Self Care
D013812	Therapeutics