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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: blood glucose measurement

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement performance	invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus).	up to 1 day

Collaborators and Investigators

• Sponsor: Sciema UG
• Collaborators: Cnoga Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CNG-NGM-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No