Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

Study Overview
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Brief Summary
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This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

Detailed Description
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Participants will be enrolled at six different sites in four different countries. All participants will undergo identical procedures, which include four steps: Baseline visit (1 day), calibration period (25 days), validation period (23 days) and a close-out visit (1 day) with a total duration of 50 days. The calibration period consists of 23 home-based days and two in-clinic days. At the two in-clinic days, measurement sessions are performed every 30 minutes. A measurement session consists of two reference measurements (Contour Next One) and three measurements on the Investigational Medical Device. The glucose level of the participants is manipulated by administration of a glucose rich drink. At home-based days, the subject must perform four measurement sessions a day. During the validation period, participants perform up to four home-based measurement sessions a day.

Official Title
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Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Prototype 0.5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects ≥18 years of age Diagnosed with diabetes, all types except gestational diabetes Skin phototype 1-4 Willing to perform a minimum of 8 finger sticks during each day of home-based measurements and 30 finger sticks at the two in-clinic study days Subject has a wireless internet connection at home to be used in the study Exclusion Criteria: For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration For female subjects: Breastfeeding Subject currently participating in another study Subject not able to understand and read the local language In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease) Subject diagnosed with cardiovascular diseases Reduced circulation in right hand evaluated by Allen's test Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity Radiotherapy for the past six months Extensive skin changes, tattoos or diseases on right hand thenar (probe application site) Known allergy to medical grade alcohol used to clean the skin Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSP-20<br>Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 48 days. | Device: Prototype 0.5<br>* Investigational Medical Device collecting spectral Raman data non-invasively from tissue<br>* Other names: P0.5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement accuracy | Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD). | 6 months | 
| Safety evaluation: paucity of adverse events | Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical study | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device deficiencies | Description of device deficiencies will be listed. Deficiencies will be reported during the clinical study. | Up to 6 months | 
| Device usability | The use of the device will be evaluated by means of questionnaires. The subjects are asked if they encountered any problems during measurements, and if so, to elaborate the problems encountered. | 6 months | 

 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