Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
Conditions: Glucose Metabolism Disorders, Diabetes Mellitus
Sponsor: Tirat Carmel Mental Health Center

17/10/2017
SPECTROPHON Glucometry Monitor Accuracy Study
NCT03359629
Authors:
Dmitry Rodin, Anatoly Kreinin,
Albert Pinhasov, Gleb Zilberstein
1. Kiryat Carmel Hospital, Israel 
2. Ariel University, Israel 
3. Spectrophon LTD, Rehovot, Israel 
4. Maale HaCarmel Mental Health Center, Israel 
 Protocol date: 21/05/2017, ver. 2
-2017 –

Study Design 
This study will examine the accuracy of Spectrophon NIGM incorporated 
in smart watches that noninvasively and indirectly detect the level of 
glucose in human blood. Adult subjects (n=200; both healthy individuals 
and participants with diabetes) will be recruited for the study in Maale 
Carmel Mental Health Center (MCMHC). In parallel to glucose 
measurements with NIGM, blood will be collected and the glucose level 
will be checked. An intravenous cannula (Venflon) will be inserted in 
cubital vein and blood will be collected twice in the beginning and at the 
end of the procedure and checked for glucose level with YSI 2300 
Glucose Analyzer.
The measurements will be performed twice: before meal (subject should 
be in fasting state) and after meal with one-hour interval between two 
measurements.
The results of the measurements of the spectrometer biosensor will be 
compared to the results obtained from the YSI 2300 Laboratory Glucose 
Analyzer. 
Inclusion criteria (for the group of healthy participants):
Healthy individuals between ages 18 and 75 that do not have diabetes and 
are able to sign informed consent form.
Exclusion criteria (for the group of healthy participants):
Hepatitis or HIV, tuberculosis, diabetes, hemophilia and other serious 
coagulation disorders, significant impaired venous access, pregnancy.
Inclusion criteria (for the group of participants with diabetes):
Clinical diagnosis of diabetes (I type, II type), age: 18-75, able to sign 

informed consent form.
Exclusion criteria (for the group of participants with diabetes):
hepatitis or HIV, tuberculosis, hemophilia and other severe coagulation 
disorders, significantly impaired venous access, pregnancy. 
Procedure 
In the beginning of the experiment a participant must be in fasting state.
A blood sample is collected and checked for the glucose level with the 
reference devices YSI 2300 Glucose Analyzer. 
NIGM is applied to the participant's skin after taking blood sample. 
NIGM non-invasively measures glucose level in triplicate samplings.
After blood sampling, the participant receives food (no limitations to food 
type and quantity). 
60 min. after meal, the second blood sample is collected and checked for 
the glucose level. NIGM is applied again to participant’s skin after taking 
blood sample. NIGM non-invasively measures glucose level in triplicate 
samplings.
The application automatically saves every measurement into archive. To 
better control the process, the manual fixation of data obtained by NIGM 
is performed. 
Statistical analysis 
Mean absolute relative difference between Spectrophon NIGM, YSI 2300 
Laboratory Glucose Analyzer and Accu-Chek Performa NC will be 
estimated for every sample to control the accuracy of the obtained data. 

Regression analysis tools will be used to estimate the accuracy of NIGM 
measurements. 
Principal investigator
Prof. Anatoly Kreinin
Signature
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