Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

Study Overview
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Brief Summary
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This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Detailed Description
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Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Official Title
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Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Working Model 3.4NR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects 18-70 years old Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients) Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents 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 > 10 cigarettes pr. day Participants not able to understand and read Swedish In investigator's opinion, participant 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 Rejection by screening optical measurements Known allergy to medical grade alcohol Known allergy to adhesives Systemic or topical administration of glucocorticoids for the past 7 days Participants undergoing dialysis treatment Anti-coagulation or anti-platelet therapy Use of beta-blockers Medical conditions causing bleeding tendency 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. Such conditions include but are not limited to HIV and Hepatitis B or C. Participants currently enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSP-08<br>All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection. | Device: Working Model 3.4NR<br>* Investigational Medical Device collecting spectral Raman data from tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation and validation of prediction models - MARD | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure. | One year | 
| Generation and validation of prediction models - ISUP | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure. | One year | 
| Generation and validation of prediction models - Consensus Error Grid | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study. | One year | 
| Safety evaluation: paucity of adverse events | Safety will be evaluated in a descriptive manner by the paucity of adverse events | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive glucose monitoring, Raman spectroscopy