Status:
COMPLETED
Use of CoG by Patients With Diabetes Mellitus
Lead Sponsor:
Sciema UG
Collaborating Sponsors:
Cnoga Medical Ltd.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-90 years
Brief Summary
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive op...
Detailed Description
The trial starts with a screening and training visit (V1). This is followed by an individual calibration period for the non-invasive device component by means of multiple parallel measurements with th...
Eligibility Criteria
Inclusion
- Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American origin
- Subjects who are able to provide informed consent (by him/herself or by his/her guardian);
- 18 years old and above;
- HbA1c \< 10 %
- Anatomically suitable finger as determined by the clinical investigator and detailed in section 4
Exclusion
- Does not meet inclusion criteria;
- Subjects requiring dialysis;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars and/or tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin injuries on the measured finger;
- Severe disease conditions (cancer etc.)
- Any condition that may prevent patients from successful participation in the trial (in discretion of the investigator)
Key Trial Info
Start Date :
July 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03840161
Start Date
July 16 2018
End Date
March 31 2019
Last Update
January 18 2020
Active Locations (1)
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1
Mills-Penisnsula Medical Center
San Mateo, California, United States, 94596