Plain English Summary
Background and study aims
The TensoTip ComboGlucometer (CoG) uses a painfree (non-invasive)method (by sending light with different wavelengths during a selected finger) to measure the sugar levels in the tissue of the finger. A second device, the MTX meter, uses the same technology to measure other body signals such as blood pressure, pulse, oxygen saturation, number of red blood cells, and others. In this study, the primary goal is to measure how close the CoG meter results are to commonly measured blood sugar values when the patient is eating a breakfast.
Who can participate?
People aged 18-80 years who are healthy or have type 1 or type 2 diabetes. People with HIV infection or hepatitis, people receiving dialysis, women who are breastfeeding or pregnant and people with scratches, scars, tattoos or skin conditions on the finger cannot take part.
What does the study involve?
Participants will eat breakfast at the trial centre. Measurements of blood sugar and other body signals will be taken at 30-minute intervals during the meal and for 3 hours after starting the meal using the CoG and MTX devices and other standard methods. For example, blood pressure will be tested with arm cuffs. After this meal experiment, the participants will be allowed to use the CoG device at home for blood sugar monitoring for 3 months. This gives them access to an unlimited number of pain-free blood sugar tests. Blood will be taken before and after the 3 months to investigate whether using a pain-free device at home can improve the overall well-being of the participants and their long-term blood sugar control.
What are the possible benefits and risks of participating?
Where is the study run from?
Pfützner Science & Health Institute in Mainz, Germany.
When is the study starting and how long is it expected to run for?
July 2017 to August 2017.
Who is funding the study?
CNOGA Medical Ltd, an Israeli company that makes the CoG and MTX devices.
Who is the main contact?
Prof Dr Andreas Pfützner, Pfützner Science & Health Institute.
Trial website
Contact information
Type
Scientific
Primary contact
Prof Andreas Pfützner
ORCID ID
http://orcid.org/0000-0003-2385-0887
Contact details
Pfützner Science & Health Institute
Haifa-Allee 20
Mainz
55128
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CNG-NGM-001
Study information
Scientific title
Evaluation of the CNOGA Combo glucometer and the MTX non-invasive body signaling device during a standardized meal test in patients with diabetes mellitus and in healthy subjects in comparison with point-of-care reference methods for the respective parameters
Acronym
CNOGA MEAL STUDY
Study hypothesis
The purpose of this clinical study is to demonstrate the performance of both non-invasive CNOGA devices the TensorTip CoG measuring glucose and Hb A1c levels and the TensorTip MTX measuring different vascular biomarkers (blood pressure (systolic and diastolic) and SpO2, hemoglobin, peripheral pulse rate (PPR), pCO2, pO2, MAP, HCT, CO, pH, BV, peripheral pulse wave (PPW), graphs of BP variation and additional hemodynamic parameters and graphs), when operated according to its instructions for use.
Ethics approval
Ethikkommission der Landesärztekammer Rheinland-Pfalz (Ethics Committee of the Chamber of Physicians of the State of Rheinland-Pfalz), 12/07/2017, 00010925
Study design
Prospective single-center open-label uncontrolled 3-month study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Accuracy of devices in measuring health-related parameters in people with diabetes mellitus and healthy people
Intervention
The participants are trained to use the CNOGA Comboglycometer or the MTX Multimarker devices and will calibrate them for 1 week at home with multiple comparative measurements with an invasive blood sugar meter. Thereafter, they come to the trial site in the morning after an overnight fast and will eat a standardized breakfast and take their usual medication. Blood sugar will be measured 11 times before and after the meal uptake for a total of 3 h with several blood sugar meters and a reference method (YSI 2300 Stat Plus). Participants can then leave the site. The participants will then be allowed to use the devices at home for a total of 3 months. Additional visits will occur after 6 weeks (interim) and 12 weeks (final). At these visits blood will be drawn for measurement of glycemic control (HbA1c). At the final vist, the patients will also complete a standardized questionnaire regarding device use. This will conclude the study. Total study duration for one participant: 14 weeks
Intervention type
Device
Phase
Drug names
Primary outcome measure
The primary outcome parameter is the mean observed difference between the non-invasive sugar measurements with the CNOGA ComboGlucometer and the reference method during the trial site visit.
Secondary outcome measures
1. Mean observed difference between the invasive blood sugar measurement with the CNOGA device and the reference method during the trial site visit
2. Comparison of long-term sugar control (HbA1c) at baseline and after 3 months
3. Other body signals (blood pressure, pulse, tissue oxygenation and others) will be measured with the non-invasive MTX device and compared to clinical reference methods during the meal experiment
Overall trial start date
01/05/2017
Overall trial end date
30/11/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 1 diabetes mellitus or type 2 diabetes mellitus or healthy subjects
2. Aged 18-80 years
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
15 patients with type 2 diabetes, 15 healthy subjects, 6 patients with type 1 diabetes
Participant exclusion criteria
1. Subjects requiring dialysis
2. Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos
3. Pregnancy
4. Nursing mothers
5. Any skin scratch(es) on the measured finger
6. Diagnosis of HIV infection or hepatitis
Recruitment start date
15/07/2017
Recruitment end date
30/08/2017
Locations
Countries of recruitment
Germany
Trial participating centre
Pfützner Science & Health Institute
Haifa-Allee 20
mainz
55128
Germany
Sponsor information
Organisation
CNOGA Medical Ltd.
Sponsor details
5 TarishStreet
North
Caesarea 30889000
Israel
Caesarea
30889000
Israel
+972 (4)-636-1080
ella@cnoga.com
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
CNOGA Medical Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published at the ATTD conference in February 2018 in Vienna and at the German Diabetes Conference in May 2018 in Berlin. In addition two manuscripts (overall study results and subgroup analyses) have been submitted to J. Diabetes Sci. Technol. and Diabetes Technol. Ther., respectively.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/03/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list