Status:
COMPLETED
User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
Lead Sponsor:
Sciema UG
Collaborating Sponsors:
Cnoga Medical Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 langu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT03870971
Start Date
February 4 2019
End Date
August 31 2019
Last Update
January 18 2020
Active Locations (1)
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1
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057