Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Study Overview
=================
Brief Summary
-----------------
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects

Detailed Description
-----------------
Subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary Blood Glucose comparator or 8 capillary Blood Glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. Subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Official Title
-----------------
Performance Characteristics of Non-invasive Glucose Monitoring Device Prototypes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: P0.2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 18 years of age or older Diabetic patients (all types) Skin phototype 1-4 Exclusion Criteria: For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration For female participants: Breastfeeding Subjects not able to understand and read Danish In Investigator's opinion, subject is not able to follow instructions as specified in the protocol Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease) Diagnosed with reduced circulation Extensive skin changes, tattoos or diseases on probe application site Known allergy to medical grade alcohol Known allergy to adhesives, applicable to subjects in RSP-16-01 Systemic or topical administration of glucocorticoids for the past 7 days and under investigation Participants undergoing dialysis treatment Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. Participants currently enrolled in another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short term collection of IMD data<br>Subjects will collect spectral raman data on P0.2 for minimum 10 hours per day with a maximum of 15 minutes between each measurement for 5 days distributed over a time period of 10 days. Spectral data will be compared to standard BG and/or FGM measurements. | Device: P0.2<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Medium term collection of IMD data<br>Subjects will collect spectral raman data on P0.2 for four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. | Device: P0.2<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Long term collection of IMD data<br>Subjects will collect spectral raman data on P0.2 for four times a day for 90 days distributed over a time period of 6 months. Spectral data will be compared to standard BG measurements. | Device: P0.2<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|
| Experimental: Medium term collection of IMD data, increased # of sessions<br>Subjects will collect spectral raman data on P0.2 four times a day for 30 days distributed over a time period of 40 days. Spectral data will be compared to standard BG measurements. The number of optical sessions performed each time measurements are done are increased compared to the investigation's second arm. | Device: P0.2<br>* Investigational Medical Device collecting spectral raman data from tissue.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of predictive algorithms for determining blood glucose levels | Collected spectral raman data will found the development of predictive algorithms for glucose determination. | 3 years | 
| Validation of predictive algorithms for determining blood glucose levels | Performance of predictive models will be evaluated using the consensus error grid. | 3 years |