Clinical trial NCT03840161: Use of CoG by Patients With Diabetes Mellitus
Official title: Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus Type 1
Diabetes mellitus Type 2
blood glucose self-testing
non-invasive tissue glucose prediction
optical pain-free glucose testing
Lead sponsor: Sciema UG
Sponsor class: OTHER
Collaborators: name: Cnoga Medical Ltd.
First posted: 2019-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian origin, who are experienced with performing blood glucose self-testing.

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 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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.
timeFrame: Experiment will be performed twice within 3 months
measure: CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.
timeFrame: Experiment will be performed twice within 3 months
Secondary outcomes:
measure: Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes
timeFrame: 3 months
measure: Treatment satisfaction questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Mills-Penisnsula Medical Center
state: California
Study officials:
affiliation: Sciema UG
name: Filiz Demircik, PhD
role: STUDY_DIRECTOR
References: