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

NCT03870971 | Completed DMC

• 1 other identifier: CNG-NGM-005
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• years old and above;

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciema UG: lead
• Cnoga Medical Ltd.: collaborator

Study Sites (1)

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 12, 2019
• Study Start: February 4, 2019
• Primary Completion: July 8, 2019
• Study Completion: August 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)