Study to explore how accurately the CNOGA Combo glucose meter and the MTX meter measure blood sugar, blood pressure and other important body information when people are eating a meal

ISRCTN ISRCTN33202080
DOI https://doi.org/10.1186/ISRCTN33202080
Secondary identifying numbers CNG-NGM-001
Submission date
27/03/2018
Registration date
24/05/2018
Last edited
23/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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.

Contact information

Prof Andreas Pfützner
Scientific

Pfützner Science & Health Institute
Haifa-Allee 20
Mainz
55128
Germany

ORCiD logoORCID ID 0000-0003-2385-0887

Study information

Study designProspective single-center open-label uncontrolled 3-month study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation 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
Study acronymCNOGA MEAL STUDY
Study objectivesThe 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(s)Ethikkommission der Landesärztekammer Rheinland-Pfalz (Ethics Committee of the Chamber of Physicians of the State of Rheinland-Pfalz), 12/07/2017, 00010925
Health condition(s) or problem(s) studiedAccuracy of devices in measuring health-related parameters in people with diabetes mellitus and healthy people
InterventionThe 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe 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 measures1. 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 study start date01/05/2017
Completion date30/11/2017

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants15 patients with type 2 diabetes, 15 healthy subjects, 6 patients with type 1 diabetes
Key inclusion criteria1. Type 1 diabetes mellitus or type 2 diabetes mellitus or healthy subjects
2. Aged 18-80 years
Key exclusion criteria1. 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
Date of first enrolment15/07/2017
Date of final enrolment30/08/2017

Locations

Countries of recruitment

  • Germany

Study participating centre

Pfützner Science & Health Institute
Haifa-Allee 20
mainz
55128
Germany

Sponsor information

CNOGA Medical Ltd.
Industry

5 TarishStreet, North
Caesarea 30889000, Israel
Caesarea
30889000
Israel

Phone +972 (4)-636-1080
Email ella@cnoga.com
Website www.cnoga.com

Funders

Funder type

Not defined

CNOGA Medical Ltd

No information available

Results and Publications

Intention to publish date01/03/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planResults 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 planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.