Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus

Use of CoG by Patients With Diabetes Mellitus

Sponsors

Lead sponsor: Sciema UG

Collaborator: Cnoga Medical Ltd.

Source Sciema UG
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.

Overall Status Completed
Start Date July 16, 2018
Completion Date March 31, 2019
Primary Completion Date February 28, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment. Experiment will be performed twice within 3 months
CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment. Experiment will be performed twice within 3 months
Secondary Outcome
Measure Time Frame
Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes 3 months
Treatment satisfaction questionnaire 3 months
Enrollment 40
Condition
Intervention

Intervention type: Device

Intervention name: non-invasive tissue glucose prediction

Description: Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)

Other name: invasive blood glucose measurement

Eligibility

Sampling method: Probability Sample

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)

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Filiz Demircik, PhD Study Director Sciema UG
Location
facility Mills-Penisnsula Medical Center
Location Countries

United States

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov