User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
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Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.
After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
patients with type 1 or type 2 diabetes or healthy
Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
18 years old and above;
Does not meet inclusion criteria;
Subjects with any other severe disease in the discretion of the investigator
Not capable to read English user instructions at the discretion of the patient
Pregnancy or Nursing mothers
Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)