PROCEDURE
Aim of the study
The main purpose of the experiment is to measure light absorption of subject tissue by non-invasive custom-made measurement tool developed at Dynamic Brain Lab Japan.
Measurements are performed based on principles of plethysmography at multiple wavelengths.
Data collection
Data will be recorded in high temporal resolution in segments of 1 minute 5 minutes in duration on two groups of people.
The former group will be tested one time while the latter will be tested three repeated times within the same day in the following two conditions: before meals and 90 minutes after meals.
Along with absorption time-series, our device will record multiple environment al measures: such as temperature, air pressure, humidity, ambient light; and characteristics of subjects: their skin tissue properties, such as temperature, and resistance.
Experimenters will collect individual information on skin color-pigmentation, general health condition (such as height, weight, bioelectrical impedance analysis, age).
Data Analysis
The aim of analysis is to improve our understanding on the effect of recorded environmental factors and individual subject differences on the light absorption of skin tissue and on the measurements recorded by custom made measurement tool. Data will be analyzed in a postdoc analysis, first by standard statistical measures and time-series analysis tools, then by an exploratory analysis using tools of modern machine learning.
The protocol proceeded as follows:
1. The testing duration spanned 3 days.
2. Participants comprised both men and women of Japanese nationality diagnosed with type 1 or type 2 diabetes;
3. No minors were involved.
4. To safeguard privacy, participants were required to sign a release form, details of which are held by the contracted agency.
5. Prior to testing, all participants were briefed on the procedures by the agency.
6. Participant identities were anonymized by assigning codes rather than using their real names, as provided by the agency.
7. Participants exclusively utilized their personal glucose monitoring devices; no blood drawing systems were supplied by us.
8. Testing involved measurements take non an empty stomach, post-breakfast, and 3 hours after breakfast, allowing participants to follow their regular daily routines.
9. Every time blood sample is taken a measure with our device Glucoscanner has to be made.
10. Our device has to be used every time on the same hand and same finger (such information has to be written in the CRF).
11. Participants should avoid movements during the measurement with our device.
Experimenters will suggest to each participant to lay the arm, forearm or even just the hand where the device is worn on a stable surface (e.g. a table).
12. Participants may use a small pillow to get a more comfortable position.
13. Glucoscanner has to be used on the arm not involved in blood sampling.
14. In case the device is not well positioned the participant will have to remove the device and wear it again.
15. People have to prick their finger before to wear our device and right after our device measurements is over.
16. Participant can use any finger except the one used with our device, they have just to prick their finger and follow the procedure they regularly use in everyday life.
Vital signs
Body temperature.
Pulse rate.
Respiration rate (rate of breathing)
Blood pressure (Blood pressure is not considered a vital sign, but is often measured along with the vital signs.)
The test outcomes proved satisfactory, affirming the validity of our efforts.
The Glucoscanner prototypes employed during the testing phase were programmed to yield numerical data.