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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870971
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Cnoga Medical Ltd.
Information provided by (Responsible Party):
Sciema UG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: blood glucose measurement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Intervention Details:
  • Other: 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

Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870971


Locations
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United States, Washington
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057
Sponsors and Collaborators
Sciema UG
Cnoga Medical Ltd.
More Information
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Responsible Party: Sciema UG
ClinicalTrials.gov Identifier: NCT03870971    
Other Study ID Numbers: CNG-NGM-005
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No