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

NCT ID: NCT03870971

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-04

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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blood glucose measurement

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

Intervention Type OTHER

Eligibility Criteria

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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;

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cnoga Medical Ltd.

INDUSTRY

Sponsor Role collaborator

Sciema UG

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CNG-NGM-005

Identifier Type: -

Identifier Source: org_study_id

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