User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | February 4, 2019 |
| End Date: | April 2019 |
| Contact: | Andreas Pfuetzner, Prof. |
| Email: | andreas.pfuetzner@pfuetzner-mainz.com |
| Phone: | +49 6131 58846 |
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.
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.
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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)
- Illiteracy
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