Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
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
Sponsors
Cnoga Medical Ltd.
Sciema UG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement performance | up to 1 day | invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus). |
Countries
United States
Outcome results
None listed