User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)

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.

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Key information

Conditions

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

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood glucose measurement

Other

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

Primary outcomes

measurement performance

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sciema UG

Other

Collaborators

Cnoga Medical Ltd.

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Mar 12, 2019
Registry last updated: Jan 18, 2020

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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Completed