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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870971
• Other study ID #: CNG-NGM-005
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2019
• Source: Sciema UG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: August 31, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Rainier Clinical Research Center, Inc.	Renton	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Sciema UG	Cnoga Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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