Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/03/2018
Date assigned
24/05/2018
Last edited
23/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

www.cnoga.com

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

Publication citations

Additional files

Editorial Notes