Use of CoG by Patients With Diabetes Mellitus

Sciema UG

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: non-invasive tissue glucose prediction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03840161

CNG-NGM-003

Details and patient eligibility

About

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.

Full 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 the invasive and the noninvasive device component. This will be done by the participants at home. Thereafter, the participants will come to the study site and will ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary blood samples for comparator readings with the two CoG components and with a laboratory reference method (YSI gucose analyzer). The patients will now continue to use the devices at home for three months, but are not allowed to use any CoG result for treatment decisions. In an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety parameters and three comparison measurements will be made with the CoG device components and the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of the first meal test visit (V2) will be repeated, which conludes that study. In addition, the participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)