Use of CoG by Patients With Diabetes Mellitus

Completed

Conditions studied: Diabetes Mellitus

In brief

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 optical component for prediction of tissue glucose at the fingertip. In this study, participants will use both devices during meal tests and also at home during routine care. The results from the device will be compared to a standard reference method and will be used to determine the accuracy of the two device components.

Key facts

Study ID

NCT03840161

Run by

Sciema UG

People needed

40

Starts

2018-07-16

Expected to finish

2019-03-31

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mills-Penisnsula Medical Center — San Mateo, California, United States

Full record on ClinicalTrials.gov

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